Strictly for Internal Use only

GLUCOBAY

• Glucobay is an innovative oral antidiabetic agent

developed in the research laboratories of Bayer AG

• The active ingredient of Glucobay is acarbose a

01 Introduction pseudotetrasaccharide of microbial origin isolated
from Actinoplanes utahensis

• Bayer ensures usage of high standard technology to

make sure yield of highly purified acarbose

Antidiabetic, preferential action on postprandial blood

02 Category
glucose
03 Chemistry Complex pseudo-tetrassacharide

• Each uncoated tablet contains :Acarbose 25mg

04 Composition
• Each uncoated tablet contains :Acarbose 50 mg

Acarbose,

Antihyperglycemic action results from competitive,

reversible inhibition of intestinal alpha-glucosidase
enzymes

• It Binds competitively & Reversibly ( in a dose-

dependent manner to the oligosaccharide binding
05 Mode of action site) to alpha-glucosidase enzymes in the brush
border of the small intestinal mucosa

• As a result, delays the digestion & absorption of

the carbohydrates in the upper part of the small
intestine

• Hence, blunts the post prandial blood glucose

levels.

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This effect lasts for 4 to 6 hours provided that acarbose

is present at the site of enzymatic action at the same time
as the oligosaccharides.

It decrease postprandial secretion of Gastric

Inhibitory Polypeptide (GIP) and increase postprandial
levels of glucagon like peptide (GLP 1).

Acarbose is poorly absorbed and systemic

bioavailability is low.
After oral administration, <2% of the unchanged drug is
absorbed and enters the circulation, with most
06 Pharmacokinetics
remaining in the lumen of the gastrointestinal tract.
The absorbed material appears in the urine as
metabolites, mostly glucose, within 14 to 24 hours.
Excretion via the kidneys predominates.

Acarbose lowered blood glucose significantly when

administered
As a monotherapy and in combination with other oral
antidiabetic drugs. Acarbose works principally to
lower postprandial hyperglycemia.
07 Clinical Pharmacology
The drug reliably reduces HbA1c and increases insulin
sensitivity.

Acarbose has not been associated with bodyweight gain.

Cause modest decrease in postprandial triglyceride levels
Hypoglycemia is not a side-effect.

Type 1 Diabetes Mellitus

08 Indications Type 2 Diabetes Mellitus

IGT or Prediabetes

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• Start with 25 mg bid or tid

• Depending upon the clinical condition of the
09 Dosage patient raise the dose to 50 mg bid or tid. as per the
therapeutic regimen.
• Glucobay should be chewed or swallow with the
first bite of the meal.

• Flatulence, diarrhea & abdominal pain (Transient)

• GI adverse effects seen only during the initial 2 to 3
weeks of treatment
• GI adverse effects are dose-dependent, mild and
10 GI- Side effects transient
• Up regulation of glucosidase enzyme activity in the
lower small intestine play a role in  GI adverse
effects
• Recommends “Start Low and Go Slow” approach
to minimize the GI side effects

1. Significant reduction of PPBG levels

2. Effective reduction of all glycemic parameters
3. Reduction of triglyceride levels
4. Decrease in Insulin resistance
5. Reduction in plasma in insulin levels
Key Points 6. Marginal reduction in body weight
7. Beneficial for the treatment of IGT besides that it also
is an effective medication for the prevention of IGT
11 8. Used frequently in type 2 and type 1 diabetic patients
where it reduces the dose of insulin giving patient a
potential benefit
9. Used also in the cases of postprandial hypoglycemia,
dumping syndrome and in patients where due to
diabetes the bowel movement is impaired
10. Used as adjuvant or monotherapy
11. Well tolerated, even on long term use
12. Can be combined with any OHA

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13. Can be used in combination with any type of

Insulin’s
14. Elevates GLP-1 response
15. Reduces cardiovascular risk, blood pressure in
hypertensive patients, vascular and ischaemic
damage
16. Improves diabetic dyslipidaemia
17. Acarbose increases insulin sensitivity and preserves
β-cell function
18. Unmatched safety profile – No systemic absorption,
no hypoglycaemia, no hyperinsulinaemia, minimal
side effects, no beta-cell exhaustion, minimal drug
– drug interactions

12 Product Packs Strip of 10 tablets

BRAND NAME COMPANY NAME
VOLIX RANBAXY
VOLIBO SUN
PPG ABBOT
Competition VOBOSE USV
13
(Voglibose) VOZUCA DR.REDDY’S
PRANDIAL CIPLA
VOBIT LUPIN
VOGLISTAR MANKIND
VOCARB GLENMARK

BRAND NAME COMPANY NAME

GALVUS NOVARTIS
Competition (VILDAGLIPTIN)
14
( Gliptins ) JANUVIA (SITAGLIPTIN) MERCK
ONGLYZA BMS
(SAXAGLIPTIN)

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TRADJENTA BOEHRINGER
(LINAGLIPTIN) INGLHEM

BRAND NAME COMPANY NAME

Competition GLUCAR GLENMARK

15
( Acarbose ) REBOSE SUN
DIABOSE MICRO

• Like metformin , Acarbose is associated with

beneficial effects on hyperglycemia,
hyperinsulinemia, body weight, and, in some
studies, triglyceride levels
• Acarbose do not have a propensity to produce
weight gain, & hypoglycemia unlike the
sulphonylureas
• Acarbose has favorable effect on PPG, FBG, HBA1c
→ reflect the overall improvement in glucose
control of the patients
• Relative risk for CVD increases with 2-hour blood
glucose irrespective of the FPG level
• Data suggest that the specific ability of acarbose to
Acarbose in Clinical reduce postprandial hyperglycaemia have a
16
practice beneficial impact on cardiovascular morbidity and
mortality
• Acarbose is approved for prediabetes, T2DM &
T1DM with insulin
• Acarbose has well-documented CV protective
benefits in prediabetes as well as in T2DM
• Additionally Acarbose has clinically documented
beneficial effects on lipid parameters, oxidative
stress, inflammatory markers, etc
• Acarbose is recommended by AACE, NICE, CDA,
IDF & ICMR Guidelines as monotherapy & as
combination therapy

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* Globally approved for *Available in only 6

the management of countries not
diabetes in >95 approved in USA
Countries including US and Europe
and Europe

* More than 300 clinical

*Only 46 clinical
reports published from >27
trial reports &
countries
publications

*PPBG reduction just in a *Effect was seen only after

month post treatment 2 months

*FBG reduction by 20
*FBG reduction
mg/dl by 11 mg/dl

Knockout Points
17
(Glucobay vs Voglibose)
*HbA1 reduction
*HbA1 reduction by
by 0.47%
0.77% *Statistically
*NO significant
significant reduction in BM
reduction in
BMI
*No published data on
direct CV benefits

*Well-documented CV
risk reduction in Pre-
diabetes & Type -2
diabetes *Japanese ministry of
health, labour & welfare
issued new revised
warnings for Voglibose
*Is documented to be that included fluminant
effective & safe even in hepatitis, hepatic function
cirrhotic patients disorder and jaundice.

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*Voglibose provides an
inferior reduction in
HbA1c than Vildagliptin
* Proven comparable
reduction in HbA1c & a
greater reduction in body
weight than Vildagliptin

STARCH

Initial results of STARCH, cross-sectional, multi-center study, confirm that

Indian type-2 diabetic subjects consume high carbohydrate containing diet

Primary Secondary

- To access how much - Compare

energy of a diabetic carbohydrate
patients come from contents &
carbohydrates composition of
diabetic population
with non- diabetic
➔ 64.1% of energy of a population
diabetic patient
comes from ➔ Dietary CHO
carbohydrates consumption &
STARCH composition was
18 observed to be
(Objectives & similar between both
Outcomes) the groups
- Out of the total energy
from the carbohydrate, %
- Assess the
of complex carbohydrate
percentage of
intake of a diabetic patients
diabetic patients
following dietary
➔ 89.2% is from
plan
complex
carbohydrates.
➔ In diabetes group,
57% were advised to
diet plan by their
physician

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➔ 66% subjects
confirmed
adherence to
diet plan
- Access the
glycemic control in
diabetics

➔ PPBG was observed

high in diabetic
population who are
consuming >60%
total carbohydrate

➔ PPBG value with in

group
consuming<50%
carbohydrate cannot
be
interpreted due to
less number of
patient

➔ Only 33.1% of
diabetic population
had HbA1c <7%

➔ PPBG in 62.5% of
diabetic population
were above the
target of 180mg/dl

- Observe the utilization

pattern of anti-diabetic
drugs

➔ Irrespective of
duration of diabetes,
most commonly
used drugs are
metformin and
sulfonylureas

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followed by TZD,
Insulin, AGIs &
DPP4 inhibitors

• Study enrolled total 796 subjects (385

diabetic & 409 non- diabetic population)
from 10-centers across India
• Carbohydrate constitute ~ 64.3% of total energy
from diet in diabetic population, which is higher
than recommended
• 89.2% of carbohydrate consumed by diabetics are
complex
• Dietary composition seems to be similar in
STARCH diabetic & non- diabetic group
19 (Summary key • Only 33% diabetic subjects have HbA1c
highlights) <7%
• PPBG of 62.5% diabetic population were
above the target of 180 mg/dl
• Diabetes group confirmed that ~66% adhere
to dietary plan as advised by their
physicians
• Dietary carbohydrate influence glycemic
control and needs intervention in term of
patient education and modalities like use of
AGIs like Acarbose

STARCH reveals

Indian Diabetics consumes High amount of CHO in

their diet

STARCH
20 High carbohydrates may result in higher
(Clinical Implications)
PPG in patients with diabetics

Post prandial hyperglycemia contributes to

HbA1c

Several treatment options are available

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Acarbose is the best treatment option due to its

unique MOA

Delays the digestion & absorption of the

carbohydrates in the brush border of the small
intestine

Hence, blunts the PPBG Spikes

Also provides the GLP-1 response with the

proven CV benefits

FLATULENC- Transient effect with Glucobay

Doctor I understand the problem of flatulence faced by

your patients.

You would also agree with me that flatulence with your

patients is due to Glucobay’s unique mode of action &
non-availability of the alpha-glucosidase enzymes in
the lower part of the small intestine.
The undigested carbohydrates in the lower part of the
21 IMP. FAQ
small intestine, with the help of bacteria (intestinal
anaerobic), ferment into carbon dioxide, methane and
hydrogen which results into flatulence.

Within 2 to 3 weeks, there is up - regulation of alpha-

glucosidase enzyme in the lower part of the small
intestine too & the flatulence problem gradually
disappears over time.

10

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For Improved patient compliance & tolerability with

Glucobay,
We recommend a “Start Low, Go Slow” approach.

Doctor , Glucobay is available in 2 strengths 25mg &

50mg & the dosage recommendation is to start in week
1 & 2 with 25/50mg OD and gradually up titrate it in
week 3 & 4 to 25/50 mg BD & further up titrate it to
25/50 mg TID in week 5 & 6 to achieve desired glycemic
control. Hence, study also proves lower GI sideeffects in
the step-wise dosage regimen than the patients taking
the full dose.

Hence, flatulence is only a transient effect with

Glucobay.

11

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GLUCOBAY-M

Glucobay® -M 25
Each film coated tablet of Glucobay® -M 25 contains 25 mg
Composition of
01 Acarbose with 500mg Metformin Hydrochloride
Glucobay® -M 50
Each film coated tablet of Glucobay® -M 50 contains 50 mg
of
Acarbose with 500mg Metformin Hydrochloride
Acarbose –
• 1. It Binds competitively & Reversibly ( in a dose-
dependent
manner to the oligosaccharide binding site) to alpha-
glucosidase enzymes in the brush border of the small intestinal
mucosa

Mechanim • As a result, delays the digestion & absorption of the

02
of action carbohydrates in the upper part of the small intestine

• Hence, blunts the post prandial blood glucose levels.

.
Metformin
2. Decreases hepatic glucose production, decreases intestinal
absorption of glucose, and improves insulin sensitivity
by increasing peripheral glucose uptake and utilization

12

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• Metformin and Acarbose, having distinct and

Medical complementary
Rationale for modes of action, have additive effect in combination and are
Fixed Dose
effective in patients with diabetes that is not adequately
Combination of
Acarbose controlled by either agent alone.
and
Metformin • In combination with Metformin, Acarbose has been shown
(GlucobayM to improve long-term glycemic control
)

• Thus fixed dose combination of Acarbose and Metformin

has beneficial effects on
03
- hyperglycemia
- hyperinsulinemia
- body weight
- triglyceride levels.

• B o t h Acarbose and Metformin have additive effect in

reducing cardiovascular complications.
• It will also help improve patient compliance since the number
of daily tablets will decrease because of the fixed
dose combination.

• Better patient compliance will lead to better glycaemic control

Parameter Acarbose - Metformin Glucobay® M
Feature – Feature
- Benefit
Absorption Acts locally in Rapidly Rapid onset
GI tract, absorbed of action
where it with a
rapidly bioavailabi
achieves high l ity of 50
04 Pharmacokinetics concentration -
s 60%
Half-life 2 hrs. 6 hrs. Can be given
(t1/2) twice or
thrice daily
Dosage 2 – 3 times 2 – 3 times Can be given
frequency/ twice or
day thrice daily

13

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Metabolis No systemic No hepatic Minimal

m Metabolism metabolism systemic
drug
interactions in
liver
Excretion GI & Renal Renal Not
recommende
d in
renal
insufficiency
• Metformin and Acarbose, having distinct and complementary
modes of action and have additive effect in combination.
• Effective in patients with diabetes that are not adequately
controlled by either agent alone
• Studies have shown that Acarbose is a safe and effective
adjunct to Metformin
0 Salient Features • Beneficial effects on hyperglycemia, hyperinsulinemia, body
5 weight, and triglyceride levels.
• Acarbose & Metformin independently reduce the
risk of cardiovascular disease
• Improves long-term glycemic control (HbA1c measurement)
by 0.8%, 0.65%, and 0.9% in 3 different studies
• Improves glycemic control without weight gain.
• Well tolerated and no serious adverse events are reported
• No significant increase in hypoglycemic events
• Improves patient compliance since the number of daily
tablets will decrease
• Better patient compliance will lead to better glycaemic control
For the treatment of patients with type II diabetes mellitus,
0 Indications when diet,
6
Exercise and single agent does not result in adequate glycemic
control.
• Glucobay® -M should be used in a dosage of two to three
0 Dosage times
7 daily.
• The patient may be started on low dose initially which
may be titrated gradually to achieve desired glycaemic
control.

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• Glucobay® -M is generally well tolerated & it’s important

0 Adverse Drug to have
8 Reactions gradual increase in dose to avoid the GI disturbances.
• The common adverse drug reaction associated with
Metformin & Acarbose are nausea, vomiting, diarrhea,
flatulence, asthenia, indigestion, abdominal discomfort,
headache, constipation, dizziness and anorexia
• Hypersensitivity to either ACARBOSE or METFORMIN or to
both.
0 Contraindications • Contraindicated in patients with inflammatory bowel
9 disease, colonic ulceration, partial intestinal obstruction or in
patients predisposed to intestinal obstruction.
• Renal or hepatic insufficiency; cardiovascular and
respiratory disease with a hypoxemic state of the tissues ,
heart failure and conditions predisposing to lactic acidosis

BRAND NAME COMPANY NAME

1 Competition VOLIX-M RANBAXY
0
JANUMET MERCK
VOZUCZ-M DRL

11 Product Pack Glucobay M 25 & 50 – Strip of 10 tablet

( Metformin in Immediate Release)

15

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Q 1.Why have you combined Glucobay with

Metformin?
Ans: Glucobay is combined with Metformin to get the
FAQs additional benefit of the complimentary mode of action,
1
2 effective control over FBG, PPBG
& HbA1c, ensure CV benefits & dosage compliance. The above
benefits help to delay the progression of diabetes & thereby
provide better quality of life.

Q 2. What is the recommended dose of

Glucobay M?
Ans: Glucobay M should be taken with meals in addition
to diet & exercise. Glucobay® -M should be used in a dosage
of two to three times daily. The patient may be started on low
dose initially which may titrated gradually to achieve desired
glycaemic control.

Q 3. Why Glucobay M should be taken with

meals?
Ans: Dr. both Glucobay & Metformin are recommended with
meals along with diet & life style modification.

Q 4. What is the benefit of this fixed dose combination as

compared to prescribing these separately?
Ans: Dr Metformin and Acarbose have distinct and
complementary modes of action and have additive effect in
combination. Moreover Dr Glucobay M improves patient
compliance since the number of daily tablets will decrease
leading to better glycaemic control

Q 5. How will be the tolerance of Glucobay M since both

Metformin & Acarbose cause GI disturbance?
Ans: Glucobay M is generally well tolerated. With slow titration
of therapy the GI disturbance & their frequency can be
minimized.

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Q 6. When do you recommend Glucobay M?

Ans: Glucobay M is recommended for the treatment of patients
with type II diabetes mellitus, when diet, exercise and single
agent does not result in adequate glycaemic control

Q 7. What do you recommend if Patients are not controlled

with the lower dose of Glucobay M?
Ans: Our recommendation is to gradually increase the dose of
Glucobay M to Metformin 500mg + Acarbose 50 mg BID upto
T.I.D along with tight dietary & life style modifications.

Q 8. Why not combine Glucobay with SU’s?

Ans: Dr Diabetes being a progressive & lifelong disease the
effect of the therapy selected has to be long lasting. In case of
SU’s, primary & secondary drug failures are very common &
thus with a fixed dose combination of Glucobay with SU’s the
appropriate dosage titration may not be convenient.

Q 9. What do you recommend if Patients are not controlled

with the higher dose of Glucobay M?
Ans: In such cases Dr after considering the patient profile & the
various therapeutic options you may think of adding another
OHA or insulin to existing therapy of Glucobay M.

Q 10. How does Acarbose & Metformin ensure cardio

benefits?
Ans: Dr. you are already aware about the CV benefits of
Glucobay through STOP NIDDM trial published in Lancet &
shown to you from time to time (Reinforce the outcomes
wherever required). On the other hand Metformin reduces the
macro vascular complications of diabetes by improving
vascular endothelial functions & reducing pro-inflammatory
cytokines and oxidative stress.
Therefore, Dr. Glucobay M may help in retarding the
development of cardiovascular complications especially in
diabetics.

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EUGLIM
01 Introduction EUGLIM (Glimepiride) is a sulfonylurea, an oral
hypoglycaemic agent.
02 Category Glimepiride - 3rd generation of sulphonylurea group
Glimepiride 1mg , 2mg & 4mg tables for oral
03 Composition
administrations

04 Mode of Action
Euglim acts by,

• Blocking sulfonylurea receptors on K+ channels in

β-cells
• Reduce permeability of K+ (inhibits efflux of K+)
• Depolarization & Ca+2 entry in β-cells
• Stimulation of β–cells
• Secretion of insulin

Pancreatic effect:
▪ Increase insulin release from pancreas
▪ Suppress secretions of Glucagons

(Insulin Release)
❖ Rapid interaction with Beta cells:
(MOA) Pancreatic
05 ➢ Euglim Associates to those binding sites
Effect
within 5 -10 minutes (2 – 3 times faster than
other sulfonylurea drugs).

❖ Significance :
➢ Euglim exerts a faster effect on Beta cells to
release insulin more than other sulfonylurea.

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➢ Rapid control of blood glucose than other

sulfonylurea

❖ Euglim has shorter effect on Beta cells by which it

induces the lowest insulin releasing activity (lower
binding affinity).

❖ Significance :
➢ Euglim induces the lowest stimulating effect
on B cells to secrete Insulin So…Low risk of
hypoglycemia (Low Insulin secretion)
➢ The lowest risk of rapid depletion
(exhaustion) of the functioning B cells → Low
risk of secondary failure

Extra-Pancreatic effect:

❖ Increases the number of insulin receptors

(MOA) ❖ Increases post-receptor insulin sensitivity
06
Extra-Pancreatic Effect ❖ Increases glycogen storage in muscle and liver
❖ Decreases the hepatic output of glucose
❖ Provides insulin like effect

• The time required to reach maximum effect

[minimum blood glucose level] is about 2 - 3 hours in
type 2 diabetes.
• The glucose lowering effect is maintained for 24
07 Pharmacodynamics
hours.
• Glucose lowering effect of Glimepiride is dose-
dependent

Onset of Action Achieves peak response in 2-4 hours

Duration 24 hours with single dose
100%
08 Pharmacokinetics • Effects of food on absorption:
Bioavailability clinically insignificant
• Total protein binding: greater
than 99%

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Renal excretion: 60% & feces:

Excretion 40%
Half-life: 5 to 9 hours
Glimepiride is generally well tolerated.
The most common treatment related adverse effects
include dizziness, headache, asthenia and nausea.
09 Tolerability

Glimepiride has less severe effects on cardiovascular

variables than glibenclamide.
Hypoglycemia is known to occur in conjunction with
sulfonylurea therapy, but it has a higher incidence with the
use of glibenclamide than with other drugs of this class.

10 Side-effect In a 1-year comparative study, hypoglycemia occurred in

10% glimepiride recipients and 16.3% patients receiving
glibenclamide. The incidence of hypoglycemia during the
first month of a comparative trial was 1.7% with glimepiride
and 5.6% with glibenclamide.

1. As an adjunct to diet and exercise in patients with

non-insulin-dependent (type II) diabetes mellitus,
the recommended initial dose of glimepiride is 1 or
2 milligrams once daily. The drug should be given
with breakfast or the first main meal. After reaching
a dose of 2 milligrams, dose increases should be
based on blood glucose responses and made in
increments of no more than 2 milligrams at 1 - to -
Dosage &
11 2 - week intervals. Usual maintenance doses have
Administration
ranged from 1 to 4 milligrams once daily; the
maximum recommended daily dose is 8 milligrams.

2. If the maximum dose of glimepiride fails to lower

blood glucose sufficiently, metformin may be added
to glimepiride monotherapy. The dose of each agent
should be adjusted to achieve desired blood glucose
control; however, the minimum effective dose of
each agent should be used.

20

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3. In type II patients with secondary failure,

combined therapy with insulin may be considered.
Fasting blood glucose levels for instituting
combination therapy have usually been greater than
150 milligrams/deciliter. The recommended dose of
glimepiride is 8 milligrams once daily, with the first
main meal. After beginning low-dose insulin, the
insulin dose should be adjusted upward on a
weekly basis, determined by blood glucose. When
stabilization is achieved, frequent patient
monitoring of capillary blood glucose is suggested,
preferably daily. Adjustments of insulin dose may
be required periodically based on glycosylated
hemoglobin and blood glucose levels.

It is suggested that in elderly and in patients with renal and

Dosage in elderly, renal mild hepatic insufficiency, glimepiride 1 milligram once
12 and hepatic
daily be given initially. The drug should probably be
insufficiency
avoided in patients with more severe liver dysfunction.

1. Euglim offers more blood glucose control with less

insulin

Glimepiride has action on peripheral cells.It enhances the

translocation of GLUT4 on cell membrane .

2. Euglim ensure longer diabetic control

13 Advantages of Euglim
As compared to other sulfonylureas, Glimepiride achieves
good glycemic control with less insulin because of its
insulin-mimetic effects on peripheral cells Less hyper
insulinemia with glimepiride. Hyper insulinemia is one of
the possible risk factor for the development of diabetic
complications.Because of this effect of glimepiride on beta
cells, the beta cells will not get exhausted as early as with

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other sulfonylureas; therefore the secondary failure rate

would be less.
Thus, glimepiride remains effective for longer period of
time.

3. Euglim offers faster glycemic control

Glimepiride binds to the sulfonylurea receptor 2-3 times

faster as compared to other sulfonylureas The action of
glimepiride starts quickly to control postprandial
hyperglycemia. Glimepiride causes more rapid fall in blood
sugar (as compared to Glibenclamide) & the reduction in
blood sugar is greatest in first four hours.

4. Euglim is safe

Glimepiride dissociates from the sulfonylurea receptor

8-9 time faster as compared to other sulfonylureas. The
action of glimepiride gets terminated immediately,
because of which the risk of hypoglycemia is very less.

5. Euglim is easy to take

Glimepiride is given as once daily dose Better patient

compliance

BRAND NAME COMPANY NAME

AMARYL SANOFI

14 Competitors ZORYL INTAS

GLIMY DRL
BETAGLIM PANACEA

22

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EUGLIM-M
Features Metformin
(N,N-
dimethylimidodicarbonimidic
diamide hydrochloride)
Chemical name
and structure
Plasma protein binding is
negligible. The mean Vd
Pharmaco- ranged between 63-276 L.
Kinetics Excreted unchanged in the
urine. Eimination half-life is
approximately 6.5 hours.
Cimetidine, thiazides,
Drug
corticosteroids, furosemide
Interactions
nifedipine etc.
Gastrointestinal symptoms,
including diarrhea may impair
Adverse
absorption of vitamin B12 and
effects
folic acid during long-term use
or poor diet.
Decreases hepatic glucose
Mechanism of production, decreases intestinal
Action absorption of glucose and
improves insulin sensitivity
(increases peripheral glucose
uptake and utilization)
Strictly for Internal Use only
Glimepiride
1-[{p-[2-(3-ethyl-4-methyl-2-
oxo-3-
pyrroline-1-
carboxamido)ethyl]
phenyl}sulfonyl]-3-
(trans-4-
methylcyclohexyl)urea
Completely absorbed. Plasma
protein binding is 99.4% and
the volume of distribution is
8.8L. metabolized mostly in the
liver Pharmacokinetics is
similar in elderly and younger
patients.
Beta-blockers, calcium channel
blockers, anti-inflammatory
drugs, thyroid hormone or
sulphonamides etc.
Nausea, vomiting, sensations
of pressure or fullness in the
epigastrium
Increase insulin release from the
beta cell. Also increases glucose
transport and glucose
transporter expression (GLUT1
and GLUT4), lipogenesis and
glycogenesis
23
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Product
Strip of 10 tablets
Packs

EUGLIM-M 1 and 2 mg
(Glimepiride and Metformin SR
Tablets) Composition:
Composition EUGLIM-M 1 mg
Each uncoated bilayered tablet
contains: Glimepiride USP
1 mg
For the treatment of patients with Type II diabetes mellitus when
Indication diet,
exercise and the single agent do not result in adequate glycemic
control
Glimepiride 1 mg / Metformin hydrochloride 500 mg: 1-2 tablets
once
daily up to a maximum of 3 tablets per day or as directed by
physician. Glimepiride 2 mg I Metformin hydrochloride 500 mg : 1
tablet once daily
Dosage & or as directed by the
administrati on physician.
Dosage must be individualized on the basis of both effectiveness and
tolerance, while not exceeding the maximum recommended daily
dose. The maximum recommended daily dose of metformin in adults
is 2000 mg and glimepiride is 8 mg once daily.
Do not crush or chew the tablet; the whole tablet to be taken with
water. Start with one tablet per day. The aim should be to decrease
both fasting
plasma glucose and glycosylated hemoglobin levels to normal by
using
the lowest effective dose of the
drug.
METFORMIN GLIMEPIRIDE

Advantageous features of Glimepiride differs from other

metformin in the treatment of
type 2 diabetes
-Antihyperglycaemic efficacy
-Counters insulin resistance
-Not cause weight gain
-Hypoglycaemia unlikely
Important -Can improve lipid profile
features -Anti-atherothrombotic effects
SUs in a number of respects:
-Associated with a lower risk of
hypoglycemia.
-Less weight gain
-Can be used in older patients
and those with renal
compromise.
-Preserves myocardial

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 Strictly for Internal Use only

-Some beneficial CV outcomes Preconditioning (a protective

-Conveniently combined with
other antidiabetic agents
mechanism that limits damage
in the event of an ischemic
event).
-Associated with a reduced risk
of myocardial damage.
-More effective in preventing
cardiac arrhythmias.

Renal disease or renal Known hypersensitivity to drug.

dysfunction (e.g., as suggested Diabetic ketoacidosis, with or
by serum creatinine levels ≥1.5 without coma.
mg/dL [males], ≥ 1.4 mg/dL
Contraindication [females], known
hypersensitivity to drug, acute
or chronic metabolic acidosis,
including diabetic ketoacidosis,
with or without coma.
Precaution in o Pregnancy: Pregnancy is generally regarded as a contra-
special
indication and insulin should be used in all pregnant
population
diabetic women.
Nursing Mothers:
o The ingredients in the combination may enter breast milk
and is best avoided in nursing mothers.
Elderly patients:
o Caution is advised in elderly patients. Frequent monitoring of serum
creatinine and dose reduction is recommended in this age group.

FEATURES BENEFITS
Fixed dose combination Simple to Rx, Simple to take,
Improves compliance.
Complementary mode of action Additive effect. Improves
glycaemic control compared to
Euglim-M monotherapy
Synergistic effect Tight & 24-hr glycaemic control
Proven Effective and Safe Anti- Improved Efficacy & Safety on a
Diabetic gold standard

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Rapid Onset of action
Effective control of Blood glucose
Levels
Effective & round the clock
glucose control
Effect on insulin resistance &
Insulin deficiency
Favourable PK PD Profile
No drug interaction
Tolerability
Low incidence of side effects
Once daily dosing
The best tested oral combination
Well tested in clinical trial
1. Amaryl M – Sanofi Aventis
2. Glycomet- GP – USV
Competition 3. Glyciphage –G – Franco- Indian
4. Gluconorm- G ---Lupin
5. Gemer forte2----Sun
Strictly for Internal Use only
Meets patients expectations,
faster reduction of glycaemic
levels.
Resolution of Symptoms &
complications
Long acting benefit in
progressed diabetes. Faster
resolution. Dosage convenience
Improved insulin sensitivity &
secretion.
Advantages in terms efficacy,
dosing, dose adjustment.
Can be combined with other
antidiabetic agent
Improves quality of life, safe in
elderly.
Patient compliance
Patient compliance
Can reduce A1C by 1.5 to 2%
Assurance regarding the efficacy
& safety in the treatment of
diabetes
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