A PROJECT REPORT ON-

Novel Route of Insulin for Diabetes Treatment

A Project Report Submitted to the Bundelkhand University in partial
fulfilment for the award of the degree Bachelor of Pharmacy

2023-24

Submitted to- Submitted by-

Dr. Shobhit Singh Anjali verma
(Assistant professor) B. Pharma final year

INSTITUTE OF PHARMACY BUNDELKHAND UNIVERSITY,

JHANSI, U.P.
Roll no. – 201251016017
Enrollment number – BU0200060172
 INSTITUTE OF PHARMACY
BUNDELKHAND UNIVERSITY, JHANSI

CERTIFICATE
This certifies that the project named, " Novel Route of Insulin for Diabetes
Treatment," which has been submitted partially satisfies the requirements for the
graduate degree Bachelor of Pharmacy, Institute of Pharmacy, Bundelkhand
University, Jhansi, is a bonafide work carried out by ANJALI VERMA under
my guidance and supervision during the academic session 2023- 2024.

Date: Head of department

Dr. Peeyush Bhardwaj
(Associate Professor & Head)
Institute of Pharmacy, Jhansi
 INSTITUTE OF PHARMACY
BUNDELKHAND UNIVERSITY, JHANSI

CERTIFICATE
This certifies that the project named, " Novel Route of Insulin for Diabetes
Treatment," which has been submitted partially satisfies the requirements for the
graduate degree Bachelor of Pharmacy, Institute of Pharmacy, Bundelkhand
University, Jhansi, is a bonafide work carried out by ANJALI VERMA under
my guidance and supervision during the academic session 2023- 2024.

Date: GUIDE:
Dr. Shobhit Singh
(Assistant professor)
BU Jhansi
 INSTITUTE OF PHARMACY
BUNDELKHAND UNIVERSITY, JHANSI

DECLARATION

I hereby declare that this project report entitled “Novel Route of Insulin for
Diabetes Treatment” was prepared by me under the direct guidance and
supervision of Dr. SHOBHIT SINGH (Assistant Professor) Institute of Pharmacy,
Bundelkhand University, Jhansi. The same is submitted to Bundelkhand
University, Jhansi in partial fulfilment of the requirement for the award of degree
of Bachelor of Pharmacy. I further declare that I have not submitted this project
report previously for the award of any degree or diploma to me.

Date: ANJALI VERMA

 ACKNOWLEDGEMENT

I want to express my gratitude to my guide, Dr. SHOBHIT SINGH for their

encouragement, insightful suggestions, and mentorship. I’d also like to extend
my thanks to the Head of the department, Dr. PEEYUSH BHARDWAJ for
allowing me to work on a wonderful project. Your assistance, guidance, and
encouragement have been invaluable. His attention to detail and organizational
skills were essential in helping me to keep track of my research. Thank you for
being a part of this project.

Date: ANJALI VERMA

SNo. Topic Page no.
Certificate i-ii

Declaration iii
Acknowledgement iv
Abstract 1

1 Introduction 2-4

1.1 India's diabetic dilemma; A growing shadow

2 Insulin chemistry and mechanism of action of insulin 5-7
2.1 Types of insulin
2.2 Insulin working mechanism
3 Novel approaches to deliver insulin 8-15
3.1 Inhaled insulin
3.2 Oral insulin
3.3 Colonic insulin delivery
3.4 Nasal Insulin
3.5 Buccal insulin
3.6 Transdermal
4 Different types of salts 16-18

4.1 Limitations of salts

4.2 Chinen Salt

5 Myths about diabetes 19-21

6 Diet and Exercise 22-23

7 Reference 24-26
 FIGURE TABLE
Sr No. List of Figures Page no.
Fig 1 Prevalence of diabetes in 2020 3
Fig 2 Structure of insulin 4
Fig 3 Insulin working mechanism 6
Fig 4 Novel approach to delivering insulin 7
Fig 5 Visual representation of chinen salt 17
Abstract
A large number of populations are living with diabetes, which is the most
common endocrine disorder which is classified into Type-I and Type-II
diabetes. Diabetes is one of the listed diseases specified in Section 3 of the Drug
and Magic Remedies Act, 1954, where advertisement of drugs for certain
diseases has been
prohibited. It can be managed or controlled with proper diagnosis and treatment
and by changing food habits. In addition to therapy with oral hypoglycemic agents,
patients are also given subcutaneous insulin injections which is traditionally used
in diabetes therapy. This multi-dose injectable therapy has relatively low patient
compliance. To avoid the associated drawbacks with this therapy, several other
delivery techniques, including oral, buccal, rectal, transdermal and pulmonary
routes were investigated for effective insulin delivery. Several novel techniques
along with novel devices are discussed in this review. The recent development in
insulin delivery and products going through various phases of clinical trials are
focused here. This review enumerates how the investigation, recent technology,
and developments in research played a pivotal role in the treatment of diabetes in
near future with alternative, safe, and efficient insulin delivery.

Keywords: Diabetes mellitus, inhaled insulin, insulin delivery, oral insulin,

technology, closed-loop system, artificial pancreas, Insulin, Diabetes,
Subcutaneous, Inhalable systems, Patient, compliance

Institute of Pharmacy, Bundelkhand University 1

Introduction
Diabetes mellitus or Diabetes, a widespread and tricky disease, hangs like a dark
cloud over global health. It affects millions across the world, throwing their blood
sugar levels off balance and causing problems in almost every part of the body.
Imagine your blood sugar like a wobbly seesaw
- diabetes makes it tilt wildly, leading to a chain reaction of complications.

In this messy maze, insulin acts as a guiding light for people with diabetes. This
super-important hormone keeps blood sugar in check, helping the body use sugar
for energy. But getting insulin into the body the right way can be tricky. Think
needles, pumps, and all sorts of hassles. This is where our journey begins!

There are primarily two types of diabetes—Type 1 and Type 2.

Type 1 Diabetes is an autoimmune condition where the immune system attacks
and destroys insulin-producing beta cells in the pancreas.
Type 2 diabetes, more common, occurs when the body does not produce enough
insulin or the body's cells resist the effects of insulin.
Secondary Diabetes Pancreatic diabetes due to pancreatitis Hormonal or endocrinal
abnormalities, i.e., acromegaly, Cushing's syndrome, pheochromocytoma, etc. Drugs
induced (latrogenie) due to steroids and thiazides Genetic syndromes associated with
diabetes, i.e., Lipodystrophies, muscular dystrophies, Klinefelter's syndrome,
Turner's syndrome, Down's syndrome, DIDMOAD (Diabetes insipidus, diabetes
mellitus, optic atrophy and deafness) syndrome Genetic defect of β cell function,
e.g., maturity onset diabetes of young (MODY I to VI)
Gestational Diabetes The text also includes a note that Secondary diabetes is a type
of diabetes that is caused by a number of factors, including genetics, environmental
factors, and medications.

This thesis sets sail on a mission to explore new ways of giving insulin. While the
old methods have helped many, they also come with limitations that can make
managing diabetes hard, discouraging people and affecting their quality of life. So,
finding a new way to deliver insulin isn't just about science, it's about helping people
with diabetes deal with daily struggles.

Institute of Pharmacy, Bundelkhand University 2

I.1 India's Diabetes Dilemma: A Growing Shadow:
Imagine over “77 million people” in India, roughly one in eleven, living with
diabetes. That's more than the entire population of Canada! Sadly, this places India
as the second most affected country by this disease, with only China having a larger
burden.

This grim picture doesn't end there. In 2020 alone, diabetes and its complications
claimed the lives of “700,000” Indians. Globally, one in six people with diabetes
comes from India, a sobering statistic considering the country's population makes up
only 17.5% of the world's total.

But what kind of diabetes are we talking about? Unlike western countries with higher
rates of Type 1 diabetes, India grapples primarily with Type 2, affecting 90- 95% of
diagnosed cases. Interestingly, while obesity is often associated with Type 2, only
about one-third of Indian diabetics have a body mass index above the "overweight"
threshold.

What is fueling this trend? Analysts attribute it to the changes in lifestyle induced
by the swift industrialization and urbanization in India. As People move from rural
to urban settings, their diets change dramatically. Urban Indians consume
significantly more animal fat compared to their rural counterparts, contributing to
increased energy intake and potentially setting the stage for Type 2 diabetes.

This shift is concerning, not just for its immediate impact, but also for its long-term
Consequences. Early exposure to these lifestyle changes translates to a higher risk
of chronic complications associated with diabetes later in life.

Institute of Pharmacy, Bundelkhand University 3

The road ahead for India's diabetes battle is long and challenging. However, understanding the
unique causes and characteristics of the disease within the Indian context is crucial for developing
effective prevention and management strategies.

Fig.1. Prevalence of Diabetes in 2020

Institute of Pharmacy, Bundelkhand University 4

• Insulin: Chemistry and Mechanism of Action of Insulin

Insulin is a 51 amino acid polypeptide discovered by Banting and Best in 1922

(Fig.2). Since its discovery, the properties of insulin have been widely studied.
However, since insulin is not easily penetrated by biofilms and destroyed in the
gastrointestinal tract by digestive enzymes, it has been administered mainly by
subcutaneous injection, which is not only inconvenient but also causes physical and
psychological pain to the patient and accompanied by a variety of adverse reactions.
The hard dose adjustment brings the risk of hypoglycemia during the long-term
administration, hampering the patient's quality of life.

Institute of Pharmacy, Bundelkhand University 5

2.1 Types of insulin
The main types are:
Short acting/ultrashort acting insulins (regular insulin or insulin analog)
Intermediate-acting insulins (modified insulins)
Long-acting insulins
Mixed insulin preparations

A. Short-acting/ultrashort acting insulins (i) Regular insulins. These are clear

solutions When injected subcutaneously, their action starts within half an hour,
reaches its peak within 2-3 hours and remains for 6 hours, hence, repeated
injections have to be given for 24 hours to control of blood glucose. They are
particularly useful in diabetic emergencies or ketoacidosis. (ii) Ultrashort-acting
insulin analogues. These are also clear solutions and their action is more rapid than
regular insulins. They start acting within 5-15 minutes, reach their peak within 30-
60 minutes and the action subsides within 2-3 hours.

B. Intermediate-acting insulins (modified insulins) These are also clear solutions.

They are absorbed from the injection site in a sustained and steady manner,
providing insulin action for 12- 16 hours. They are used to provide basal insulin
coverage throughout the day.

C. Long-acting insulins These are cloudy solutions. They are absorbed from the
injection site very slowly and provide insulin action for 24-36 hours. They are used
to provide basal insulin coverage throughout the day.

D. Mixed insulin preparations These are mixtures of short-acting and intermediate-

acting or long- acting insulins in predetermined proportions. They are available in
various combinations to provide both mealtime and basal insulin coverage.

Institute of Pharmacy, Bundelkhand University 6

2.2 Insulin working mechanism

The regulation of the blood glucose by the insulin occurs either by gluconeogenesis or
glycogenolysis process. Here the primary mechanism involves the inhibition of the
glucose production in the liver which results into higher glucose uptake by muscles
and other relevant tissues.
• Following a meal, within the time frame of1–10 min, the hyperglycemia
stimulates the specific pancreatic β cells to release insulin in very small
fractional quantities (<5%).
• The released insulin from the pancreas enters into the systemic circulation
which facilitates its distribution into one of the main target cell hepatocytes.
• In hepatocytes, insulin promotes the deposition of glucose in the form of
glycogen which results into the effective reduction of blood sugar levels.
• In addition, the insulin also reaches the cellular regions of skeletal muscles
and the adipose tissues initiating their consumption of glucose.
• In this coordinates mechanism involving insulin secretion and distribution
helps to restore the plasma sugar levels to the levels compared to the fasted
state

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Institute of Pharmacy, Bundelkhand University 8
•NOVEL APPROACHES TO DELIVER INSULIN
The subcutaneous route of insulin administration is associated with many drawbacks
such as injection pain, inconvenience, variable compliance and difficulty in
achieving postprandial blood glucose control. In addition, subcutaneous insulin
administration results in peripheral hyperinsulinemia in contrast to physiologic
delivery to the portal vein. Therefore, there is interest in delivering insulin by
alternate noninvasive routes. Currently, the pulmonary route of administration is
approved and discussed as well as other routes under investigation.

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3.1 INHALED INSULIN

Insulin delivery to the lungs was the first reported alternate to subcutaneous
injection. It has long been appreciated that insulin delivery by aerosol reduces blood
glucose. Early studies showed that delivering bovine or porcine insulin using a
nebulizer produced a prompt hypoglycemia in subjects with and without diabetes

Advantages of the pulmonary route include a vast and well perfused absorptive
surface, absence of certain peptidases that are present in the gastrointestinal (GI)
tract that breaks down insulin, and the ability to bypass the “first pass metabolism.”
However, the exact mechanism of insulin absorption across the pulmonary
epithelium remains unclear, but it is believed to involve transcytotic and
paracellular mechanisms.

The first inhaled product, Exubera® was approved by the US FDA in year 2006.
Exubera® was a dry power formulation available as 1 mg and 3 mg doses to be taken
with the help of an Inhance™ inhaler device. Exubera® was found to have
pharmacokinetic and pharmacodynamic (PK/PD) properties similar to insulin aspart
with a faster onset of action (10-15 min). In clinical trials in patients with
uncontrolled T1DM and T2DM, Exubera® was found to reduce postprandial blood
glucose and A1c significantly. However, Exubera® was contraindicated in smokers
as it increased the risk of hypoglycemia due to greater absorption compared to
nonsmokers. In addition, patients were required to undergo pulmonary function tests
before treatment initiation, after 6 months and annually thereafter.This product did
not do well commercially despite the noninvasive route possibly due to higher cost,
the bulky delivery device, concerns related to declining in pulmonary function, and
less preference by the patients and physicians. This product was withdrawn from the
market by Pfizer in 2007.

Another promising inhaled insulin is Afrezza (Sanofi and MannKind) based on

Technosphere® dry powdered formulation. The onset of action of Afrezza inhaled
insulin is 15 min and duration is 2-3 h, which is ideal for postprandial blood glucose
control. Transient nonproductive cough and a modest reduction in lung function
initially are the common side- effects. Recently, MannKind completed two large
phase 3 clinical trials with the use of this device in patients with T1DM and T2DM
and a clinical trial is under investigation in patients with already compromised
pulmonary function . This device is in the FDA approval process.
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3.2 ORAL INSULIN
The oral route of insulin administration may be the most patient-friendly way of
taking insulin and it could more closely mimic physiological insulin delivery (more
portal insulin concentration than peripheral).
However, the challenges in making oral insulin include: Inactivation by proteolytic
enzymes in the GI tract and low permeability through the intestinal membrane due to
larger size and hydrophobicity of insulin resulting in poor bioavailability. Several
pharmaceutical companies are engaged in developing carriers to protect insulin from
GI degradation and facilitate intestinal transport of insulin to deliver insulin to the
circulation with sufficient bioavailability.

Natural and synthetic nanoparticles have been used as a carrier or vehicle for insulin
such as chitosan, liposomes, polymeric nanovesicles, polylactides, poly-ε, poly-alkyl
cyanoacrylate and various polymeric hydrogels, although further discussion of these
carriers or vehicles is beyond the scope of this review.

Certain oral insulin preparations such as Capsulin, ORMD-0801, IN-105, oral

hepatic directed vesicles and Eligen completed phase 1 and phase 2 trials with
promising results.

Recently, multifunctional polymers and self nanoemulsifying drug delivery system

(SNEDDS) has been tried for oral insulin by Sakloetsakun et al. This SNEDDS was
based on thiolated chitosan. The formulations in the presence or absence of insulin
(5 mg/mL) were spherical with the size range between 80 and 160 nm. Entrapment
efficiency of insulin increased significantly when the thiolated chitosan was
employed (95.14% ± 2.96%), in comparison to the insulin SNEDDS (80.38% ±
1.22%).

After 30 min, the in vitro release profile of insulin from the nanoemulsions was
markedly increased compared with the control. In vivo results showed that
insulin/thiolated chitosan SNEDDS displayed a significant increase in serum insulin
(P = 0.02) compared to oral insulin solution. A new strategy to combine SNEDDS
and thiolated chitosan described in this study could therefore be a promising and
innovative approach to improve oral bioavailability of insulin.

Institute of Pharmacy, Bundelkhand University 11

3.3 COLONIC INSULIN DELIVERY

Oral colon delivery is currently considered of importance not only for the treatment
of local pathologies, such as primarily inflammatory bowel disease, but also as a
means of accomplishing systemic therapeutic goals. Large intestine is ideally not
suited for absorption processes for drugs but it has certain advantages over small
intestine like, long transit time, lower levels of peptidases (prevent destruction of
peptides) and higher responsiveness to permeation enhancers. Accordingly, it has
been under extensive investigation as a possible strategy to improve the oral
bioavailability of peptide and protein drugs. Oral delivery systems intended for
colonic release of insulin were devised according to microflora-, pH-and time-
dependent strategies were well described in a review by Maroni et al. Bioavailability
and pharmacological availability data are generally still far from being reliable in
terms of magnitude, onset, duration and above all, consistency for this route of
administration and it is under investigation.

Despite the enthusiasm and progress in making oral insulin, there is still a long way
to go before these products will be available in the market.

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3.4 NASAL INSULIN

In theory, intranasal delivery has several advantages over oral (bypass GI peptidases),
subcutaneous (noninvasive and painless) and inhalation route (no issue with lung
function) which makes this route attractive for the delivery of insulin. However,
intranasal delivery has shortcomings such as limited permeability of a large molecule
through the nasal mucosa and rapid mucociliary clearance resulting in variable
absorption.

Historically, intranasal delivery with early porcine and bovine insulins was
investigated in patients with T1DM. Currently, two technologies are under
investigation: Nasulin™ (CPEX pharmaceuticals) and nasal insulin by Nastech
Pharmaceutical Company Inc. Both insulin preparations have bioavailability of
about 15-25% with the onset of action ~10-20 min.Results from the phase 2 and 3
clinical trials are awaited. The substances such as bile salt, surfactant and fatty acid
derivatives are being investigated to enhance mucosal permeability of insulin but
they increase the risks for local irritation, nasal secretion, sneezing or burning
sensation.

Nasal insulin crosses the blood brain barrier hence it has a hypothesized effect on
memory functionIn a randomized placebo controlled trial with 104 adults with
amnestic mild cognitive impairment or mild to moderate Alzheimer's disease were
randomized to receive either placebo or 20 IU or 40 of intranasal insulin. Treatment
with intranasal insulin improved memory, preserved caregiver-rated functional
ability and preserved general cognition without any significant hypoglycemic event.
These improvements in cognitive
functions were correlated with changes in the Aβ42 level and in the tau protein-to-
Aβ42 ratio in cerebrospinal fluid. Based on this, large randomized controlled trials)
are ongoing to evaluate the usefulness of this agent for the treatment of Alzheimer's
disease.

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3.5 BUCCAL INSULIN

Buccal delivery of insulin has similar benefits as oral insulin with the advantage of
bypassing GI degradation. Furthermore, the relatively large surface area results in
better bioavailability. Initially, Generex Biotechnology developed Oral-lyn™ which
is a liquid formulation of short acting insulin that is administered using Generex's
metered dosage aerosol applicator (RapidMist™).
The Eli-Lilly and Generex conducted phase 1 and phase 2 trials in patients with
T1DM and T2DM with promising results. However, in 2004 both companies
dissolved their development agreements. The phase 2 clinical trial is on-going on and
further information is awaited (NCT00948493 and NCT00668850). Another
molecule being developed by Shreya Life Sciences Pvt. Ltd., India is oral
Recosulin® and the results of the phase 2 and phase 3 trials are awaited.

Another method for delivery of insulin is fast dissolving films as an alternative to

the oral tablets for rapid drug delivery. The Monosol Rx (Pharm Film Drug delivery
technology) in collaboration Midatech Company developed Midaform™ insulin,
which is delivered by buccal route. No information is available on studies using this
formulation. Another formulation “insulin loaded orally dissolved films" is
undergoing PK/PD investigation (NCT01446120).

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3.6 TRANSDERMAL

Trans-dermal insulin delivery eliminates the problems associated with needles and
injections and large surface area of the skin makes it a convenient route for insulin
delivery. However, the penetration of insulin is halted by the stratum corneum, the
outer most layer of the skin. Numerous methods have been explored to overcome the
barrier of stratum corneum.

There are several ways insulin can be delivered transdermally such as:
Iontophoresis, the technique that uses small electric currents,] Sonophereis or
phonopheresis uses ultrasound Waves, Microdermal ablation by removing the stratum
Corneum,
Electroporation utilizes high voltage pulses that are applied for a very short time,

Transfersulin is the insulin encapsulated in transferosome, an elastic, flexible vesicle

which squeeze by itself to deliver drugs through skin pores,

Insupatch™, a device developed as an add-on to an insulin pump that applies local

heat to the skin in order to increase the absorption of insulin and

Recombinant human hyaluronidase (rHuPH20) to increase insulin absorption from

subcutaneous tissue.

Additionally, microneedles with 1 µm diameter and of various lengths can deliver

insulin in effective, accurate and precise manner. Microneedle technology also can
be combined as a transdermal patch.
The transdermal insulin delivery techniques are limited by skin injury, burn or
blister formation and rarely significant pain and discomfort. These technologies are
still evolving and their long-term utility, safety and usefulness are not known at
present.

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• Different types of salts
When discussing salts in the context of diabetes control, it's essential to focus on
dietary salt, or sodium chloride, rather than alternative salts like "Chinese salt,"
which might refer to monosodium glutamate (MSG) or other specific compounds.
Managing salt intake is crucial for people with diabetes, as high sodium levels can
contribute to hypertension and cardiovascular issues. Here are some types of salts
and considerations:

• Sodium Chloride (Table Salt): This is the most common salt. While it's
necessary for various bodily functions, excessive intake can lead to
high blood pressure, a risk factor for cardiovascular complications
common in diabetes.

• Himalayan Pink Salt: Some people opt for Himalayan pink salt as an
alternative to table salt. It contains trace minerals, but the overall impact
on diabetes control is similar to that of regular salt. The key is
moderation.
• Sea Salt: Sea salt is another alternative, often praised for its natural
minerals. However, the differences in mineral content are minimal, and
it still primarily consists of sodium chloride.

• Low-Sodium Salt: This is a specially formulated salt that contains less

sodium than regular table salt. It can be a helpful option for those
looking to reduce their sodium intake.
• Salt Substitutes: Some salt substitutes use potassium chloride instead of
sodium chloride. These can be suitable for certain individuals, but those
with kidney problems or taking specific medications should consult
with a healthcare professional, as excess potassium can be problematic.

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• Limitations of salts
While some alternative salts and low-sodium options may offer potential benefits,
it's important to understand their limitations, especially in the context of diabetes
control. Here are some general considerations:
• Nutrient Content: While certain alternative salts like Himalayan pink salt and
sea salt may contain trace minerals, the amounts are typically minimal and
unlikely to have a significant impact on overall nutrition. Relying on these salts
for nutritional benefits may not be sufficient, and it's crucial to obtain essential
nutrients from a well-balanced diet.
• Individual Variability: Responses to salt substitutes or low-sodium salts can
vary among individuals. Some people may find them helpful in managing
blood pressure, while others may not experience the same benefits. It's
essential to monitor how your body responds and consult with a healthcare
professional if you have concerns.
• Potassium Concerns: Salt substitutes often use potassium chloride as a
replacement for sodium chloride. While potassium is essential for various
bodily functions, excessive intake can be harmful, especially for individuals
with kidney problems or those taking medications that affect potassium levels.
It's crucial to consult with a healthcare provider before using potassium-
containing substitutes.
• Cost and Accessibility: Some specialty salts or low-sodium products may be
more expensive or less accessible than regular table salt. Cost and availability
can be limiting factors for some individuals, making it challenging to
incorporate these alternatives into their daily diet.
• Taste Preferences: Salt substitutes or low-sodium salts may have different
tastes compared to regular table salt. Some people find it challenging to adapt
to these changes, impacting their overall satisfaction with meals. Gradual
adjustments and experimenting with herbs and spices can help enhance flavor
without relying solely on salt.

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 • Processed and Packaged Foods: Even when individuals try to reduce salt
intake by using alternative salts, they may still be exposed to high sodium
levels from processed and packaged foods. Reading food labels is crucial to
identifying hidden sources of sodium in the diet.

It's essential to approach salt intake with moderation and be mindful of overall
dietary choices. A well-balanced diet that includes a variety of nutrient-dense
foods, along with regular monitoring and consultation with healthcare
professionals, is key to effective diabetes management. Always seek
personalized advice based on your specific health needs and conditions.

Institute of Pharmacy, Bundelkhand University 18

 • Chinen salt
Chinen salt, a traditional Chinese supplement containing berberine, has emerged as
a potential player in type 2 diabetes management. This intriguing compound mimics
certain diabetes medications and activates glucose-regulating pathways, leading to
promising reductions in blood sugar levels in both animal and human studies. Chinen
salt is a supplement that contains the salt compound berberine chloride, typically
derived from Chinese goldthread (Coptis chinensis). It’s used in TCM to treat
diabetes and eliminate toxin.

6.1 How Chinen salt affects diabetes

Impact of Chinen Salt on Diabetes The primary active compound in chinen salt,
berberine chloride belongs to the alkaloid group of chemical compounds. Berberine
has demonstrated the ability to lower blood sugar levels in individuals with type 2
diabetes, as observed in both animal and human studies.

The precise mechanisms of berberine's action remain incompletely understood.

Nevertheless, it may enhance insulin secretion, reduce insulin resistance, lower
glucose absorption, and influence gut bacteria involved in blood sugar regulation. A
meta-analysis of 14 randomized studies suggests that, in conjunction with lifestyle
modifications, berberine may significantly decrease blood sugar levels compared to
a placebo, with efficacy comparable to met form in and other diabetes medications.

Fig.5. Visual representation on Chinen salt

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• MYTHS ABOUT DIABETES
To help separate fact from fiction, here are some of the myths and the actual truth about
diabetes.

• All diabetes is inherited.

Not everyone who gets diabetes inherits it. People tend to inherit the risk of NIDDM
diabetes more than IDDM. You are considered at risk for developing NIDDM if any
first-degree relatives have diabetes.

• People with diabetes should never eat sugar and sweets.

While sugar and sweets can elevate blood glucose levels, individuals with diabetes
can include sugar in their meal plans within the recommended calorie limits on
occasion. It's crucial to dispel the misconception that consuming too much sugar
alone can cause diabetes, especially if there are no other risk factors present for its
development. Diabetes doesn't solely result from sugar intake; it's influenced by
various factors, and a balanced approach to dietary choices is key in managing the
condition effectively.

• You can have borderline diabetes for many years.

There is no such thing as borderline diabetes. You either have it, or you don’t. You
have diabetes if, a) your fasting blood glucose levels are greater than 126 mg/dl, or
b) The random blood glucose is above 200 mg/dl on at least two occasions.

• Once you start taking pills or insulin, you can eat anything that you want.

The pills or insulin that you take for diabetes are more effective when they don’t
have to work as hard to lower your blood glucose. Combining your medicines with
a healthy meal plan and physical activity is the best method of control of diabetes.

• Insulin causes impotence.

Some men who have diabetes may become impotent, but not because they take
Institute of Pharmacy, Bundelkhand University 20
insulin. Impotence or erectile dysfunction is caused by damage to nerves caused by
longstanding high blood glucose. Diabetes is one of the many reasons for getting
impotence.

• The best way to judge your blood sugar level is by the way that you feel

Some people have symptoms when their blood glucose is too high or low, others do
not. Because some of the symptoms of high and low blood glucose are similar, it
can be hard to know what your symptoms mean. The only way to be sure is to check
your blood glucose.

• If my blood sugar is usually over 180 mg/dl that must be normal for me.

No. Your usual blood glucose isn’t the same as normal blood glucose. Just because
your blood glucose is usually high, does not mean that this is an acceptable blood
glucose level. High blood glucose levels that are above those recommended goals
do damage to many organs and systems in your body.

• “The doctor has prescribed me insulin. How ever I do not feel sick at
all. So I would better postpone taking insulin at a later date”

For individuals with type 2 diabetes, particularly those grappling with obesity,
modest weight loss and heightened physical activity can markedly reduce blood
glucose levels, potentially obviating the need for insulin injections. However,
delaying insulin initiation poses risks to your health. Even a brief postponement can
allow high blood glucose levels to inflict substantial harm. It's advisable to
commence insulin promptly upon recommendation, facilitating better blood glucose
control. Simultaneously, one can concentrate on weight loss and increased exercise,
fostering the prospect of diminishing the body's reliance on insulin injections over
time. Prioritizing timely insulin commencement ensures proactive management of
blood glucose levels and overall well-being.

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• “My diabetes is much more serious than some people because I have to take
insulin injection while others do not take it”

Many individuals steer clear of insulin, thinking it prevents their diabetes from
worsening. Upon reflection, this notion seems impractical. Whether or not insulin is
part of the equation, elevated blood glucose levels signify a serious issue demanding
attention. Avoiding insulin doesn't diminish the seriousness of high blood glucose;
it merely provides a convenient way to overlook the problem. Initiation of insulin
doesn't suddenly intensify diabetes; instead, it introduces a potent tool to confront an
existing serious issue. Embracing insulin marks a crucial step toward managing
diabetes and cultivating a better quality of life.

• Type 2 or NIDDM diabetes is not serious.

Type 2 or NIDDM diabetes is not serious. This is never true. All types of diabetes
are serious, and need to be taken seriously by people who have it and their families.

• “The first prescription of insulin is the prescription for rest of your life”.

Indeed, many individuals require insulin for their entire lives, and the prospect of
lifelong usage need not be a cause for concern. Unlike drug or narcotics addiction,
insulin injections are a conscious, controlled choice made for the proper functioning
of your body. While some successfully implement lifestyle changes that allow for
the safe discontinuation of insulin without elevating blood glucose levels, the key is
not to jeopardize your life for the sake of avoiding a few injections. The occasional
prick of an injection is a small price to pay for the essential management of your
health and well-being.

Institute of Pharmacy, Bundelkhand University 22

 8.Diet & Exercise
Living with diabetes requires a balanced approach to diet and exercise. Making
mindful choices in what you eat and incorporating regular physical activity into your
routine can significantly impact your blood sugar levels and overall well-being.

Diet Tips:

1. Balanced Meals:

• Include a mix of carbohydrates, proteins, and healthy fats in your meals.

• Opt for whole grains like brown rice, quinoa, and whole wheat bread.

• Choose lean protein sources like chicken, fish, tofu, and legumes.

• Incorporate healthy fats from sources like avocados, nuts, and olive oil.

2. Watch Portion Sizes:

• Be mindful of portion sizes to avoid overeating.

• Use smaller plates to help control portions.

• Pay attention to your body's hunger and fullness cues.

3. Limit Added Sugars:

• Minimize the intake of sugary snacks, sodas, and desserts.

• Opt for natural sweeteners like fruits to satisfy your sweet cravings.

4. Fiber-Rich Foods:

• Include high-fiber foods like fruits, vegetables, and whole grains.

• Fiber helps in better blood sugar control and promotes digestive health.

Institute of Pharmacy, Bundelkhand University 23

 5. Regular Meal Timing:

• Stick to regular meal timings to maintain consistent blood sugar levels.

• Include healthy snacks between meals to avoid extreme hunger.

Exercise Tips:
1. Choose Activities You Enjoy:

• Pick exercises you find enjoyable to make them a regular part of your
routine.

• Options like walking, swimming, dancing, and gardening can be

both fun and beneficial.

2. Start Slow and Gradual:

• If you're new to exercise, begin with light activities.

• Gradually increase the intensity and duration as your fitness improves.

3. Consistency Matters:

• Aim for at least 150 minutes of moderate-intensity exercise per week.

• Consistency is key to reaping the long-term benefits of physical activity.

4. Strength Training:

• Include strength training exercises at least twice a week.

• Resistance training helps improve muscle strength and insulin

sensitivity.

5. Stay Hydrated:

• Drink plenty of water before, during, and after exercise.

• Proper hydration supports overall health and aids in regulating blood

Institute of Pharmacy, Bundelkhand University 24

 sugar.

6. Listen to Your Body:

• Pay attention to how your body responds to exercise.

• If you experience discomfort or pain, consult your healthcare provider.

7. Monitor Blood Sugar Levels:

• Regularly check your blood sugar levels, especially before and after
exercise.

• Monitoring helps you understand how your body responds to different

activities.

Institute of Pharmacy, Bundelkhand University 25

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