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Slide Clinical Use of Insulin Therapy (ADA)
Slide Clinical Use of Insulin Therapy (ADA)
“Prandial” Insulin
Insulin
Level
“Basal” Insulin
SLEEP
Breakfast Lunch Dinner
Pharmacokinetic Profiles of Insulin Products
Long (Detemir)
0 2 4 6 8 10 12 14 16 18 20 22 24
Hours
Common Insulin Regimens:
Type 2 Diabetes
Continue regimen; check If fasting bg in target range, check bg before lunch, dinner and bed.
A1C every 3 months Depending on bg results, add second injection
(can usually begin with ~4 units and adjust be 2 units every 3 days until bg in range)
Pre-lunch bg out of range: add Pre-dinner bg out of range: add NPH insulin at Pre-bed bg out of range: add
rapid-acting insulin at breakfast breakfast or rapid-acting at lunch rapid-acting insulin at dinner
Continue regimen; check Recheck pre-meal bg levels and if out of range, may need to add another
HbA1C every 3 months injection; if A1C continues to be out of range, check 2-h postprandial levels and
adjust preprandial rapid-acting insulin
Continue regimen; check If fasting bg in target range, check bg before lunch, dinner and bed.
HbA1C every 3 months Depending on bg results, add second injection
(can usually begin with ~4 units and adjust be 2 units every 3 days until bg in range)
Pre-lunch bg out of range: add Pre-dinner bg out of range: add NPH insulin at Pre-bed bg out of range: add
rapid-acting insulin at breakfast breakfast or rapid-acting at lunch rapid-acting insulin at dinner
Continue regimen; check Recheck pre-meal bg levels and if out of range, may need to add another
A1C every 3 months injection; if A1C continues to be out of range, check 2-h postprandial levels and
adjust preprandial rapid-acting insulin
Glargine
Mean A1C (%)
NPH
Weeks
Basal Glargine
35 insulin *
* NPH
Hypoglycemia Episode
30
Patients (%) With 1
* * *
25
*
20
15
10
5
B L D
0
20 22 24 2 4 6 8 10 12 14 16 18 20
Time Of Day (Hours)
• If A1C is ≥7%...
– Move to Step Two…
Continue regimen; check If fasting bg in target range, check bg before lunch, dinner and bed.
A1C every 3 months Depending on bg results, add second injection
(can usually begin with ~4 units and adjust be 2 units every 3 days until bg in range)
Pre-lunch bg out of range: add Pre-dinner bg out of range: add NPH insulin at Pre-bed bg out of range: add
rapid-acting insulin at breakfast breakfast or rapid-acting at lunch rapid-acting insulin at dinner
Continue regimen; check Recheck pre-meal bg levels and if out of range, may need to add another
A1C every 3 months injection; if A1C continues to be out of range, check 2-h postprandial levels and
adjust preprandial rapid-acting insulin
• If A1C is ≥7%...
– Move to Step Three…
Continue regimen; check If fasting bg in target range, check bg before lunch, dinner and bed.
A1C every 3 months Depending on bg results, add second injection
(can usually begin with ~4 units and adjust be 2 units every 3 days until bg in range)
Pre-lunch bg out of range: add Pre-dinner bg out of range: add NPH insulin at Pre-bed bg out of range: add
rapid-acting insulin at breakfast breakfast or rapid-acting at lunch rapid-acting insulin at dinner
Continue regimen; check Recheck pre-meal bg levels and if out of range, may need to add another
A1C every 3 months injection; if A1Ccontinues to be out of range, check 2-h postprandial levels and
adjust preprandial rapid-acting insulin
Biphasic
* *
Prandial
* * * * * * *
Basal < >
* *
Injection * Self-measured glucose
N Engl J Med 2007;357:1716-30.
Mean One-year Changes
p= 0.04
20 25
20
Mean percentage change
-30
Biphasic
-40 Prandial
HbA1C FPG PPG Weight
Basal
8.5 9.6 mmol/l 12.6 85.8 kg
(%) (173 mg/dl) mmol/l (188 lbs)
(227 mg/dl)
20 8
Biphasic insulin ± prandial
Prandial insulin ± basal
Mean relative change (%)
10
No. of Events/Patient/Yr
Basal insulin ± prandial
6
0
-10 4
-20
2
-30
-40 0
Glycated Fasting Postprandial Body Hypoglycaemia
Haemoglobin Plasma Glucose Weight Grade 2 or 3
Glucose
Baseline 8.5% 9.6 mmol/l 12.6 mmol/l 85.8 kg
value 173 mg/dl 227 mg/dl 188 lbs
p value 0.28 0.83 <0.001 0.20 <0.001
Summary
• Three-quarters of patients added a second insulin
• Those commencing therapy with a basal or prandial
insulin more often achieved glycemic targets than
patients commencing with a biphasic insulin
• Patients commencing therapy with basal insulin had
fewer hypoglycemic episodes and less weight gain
Bedtime
0 10 20 30 40 50 Fasting Lunch Dinner
Time (weeks) 03:00 hr 2 hr 2 hr 2 hr
post- post- post-
breakfast lunch dinner
Subjects:
• Insulin naïve (785 entered study, 343 randomized) with type 2 diabetes
(A1C ≥8.0%)
• Receiving 2 or 3 OHAs for ≥3 months (OHAs continued except
sulfonylurea)
Additional insulin glulisine once daily (n=115)
Insulin glargine
(n=785) Additional insulin glulisine twice daily (n=113)
14 weeks
Randomization (subjects Additional insulin glulisine three times daily (n=115)
with A1C >7.0%, n=434)
24 weeks
Adapted from Raccah D.
http://www.fesemi.org/grupos/obesidad/noticias/ponencias_iv_reunion/Prof.%20Denis%20Raccah.pdf.
Accessed April 9, 2010. Cited as sanofi aventis, data on file.
1.2.3 Study: Glargine Plus 1, 2 or 3
Doses of Glulisine
HbA1c (%)
with glulisine
9.0
40 added to
glargine
37%
Subjects who 8.0
20 achieved A1C
<7.0% with 7.44
7.40
glargine during 7.29
run-in 7.0
0
Run in Randomization Wk 8 Wk 16 Wk 24
A1C in all subjects (n=785) = 9.8 at run-in and 7.3 at randomization
Adapted from Raccah D. http://www.fesemi.org/grupos/obesidad/noticias/ponencias_iv_reunion/Prof.%20Denis%20Raccah.pdf.
Accessed April 9, 2010. Cited as sanofi aventis, data on file.
1.2.3 Study: Glargine Plus 1, 2 or 3
Doses of Glulisine
5 20 0.35
(event/patient-year)
(event/patient-year)
4
from baseline (kg)
15 17.1 0.30
3.9 0.25
3.7 3.8 0.26
3 12.9 0.20
10 12.2
2 0.15
5 0.10
1 0.10
0.05
0 0 0.00
x1 x2 x3 x1 x2 x3 x1 x2 x3
Glulisine Glulisine Glulisine
7.4
7.3 7.35
7.32 7.29
7.2
A1C (%)
7.1
7.0
7.03
6.99
6.9 6.94
6.8
6.7
0
Overall Breakfast Main meal
group group
Lankisch MR et al. Diabetes Obes Metab 2008;10:1178-85.
Lankisch MR et al. Diabetes Obes Metab 2008;10:1178-85.
Summary
• Insulin is the oldest, most studied and most effective
antihyperglycemic agent but can cause weight gain (2-4 kg)
and hypoglycemia
• After 2-3 months, if FBG levels are in target range but A1C ≥7%,
check BG before lunch, dinner and bed, and, depending
on the results, add 2nd injection, generally of rapid-acting insulin.