Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea.

Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS, Baron AD

Diabetes care1 May 2005Cited by 835 (Europe PMC)

PMID15855571DOI10.2337/diacare.28.5.1083PepBankPUB-15855571

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced A1C by 0.8% from baseline and 1.0% versus placebo.
In plain wordsExenatide reduced A1C more than placebo in patients with type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseA1C change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg twice daily for 4 weeks, then 10 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Measurements
A1C change from baseline
−0.8%
exenatide 10 microg b.i.d., week 30 (SE 0.1)
A1C change from baseline
0.2%
placebo, week 30 (SE 0.1)
Placebo-adjusted A1C change
−1%
exenatide 10 microg b.i.d. vs placebo
Source sentences
Summary
Week 30 A1C changes from baseline (+/-SE) were -0.8 +/- 0.1% (10 microg), -0.6 +/- 0.1% (5 microg), and +0.2 +/- 0.1% (placebo; adjusted P < 0.0001 vs. placebo), yielding placebo-adjusted reductions of -1.0% (10 microg) and -0.8% (5 microg).
3 context sentences(design, population, supporting numbers)
Summary · context
A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks.
Summary · context
Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d.
Summary · context
Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
Report a problemFND-1585557101
02HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced A1C by 0.6% from baseline and 0.8% versus placebo.
In plain wordsExenatide reduced A1C more than placebo in patients with type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseA1C change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Measurements
A1C change from baseline
−0.6%
exenatide 5 microg b.i.d., week 30 (SE 0.1)
A1C change from baseline
0.2%
placebo, week 30 (SE 0.1)
Placebo-adjusted A1C change
−0.8%
exenatide 5 microg b.i.d. vs placebo
Source sentences
Summary
Week 30 A1C changes from baseline (+/-SE) were -0.8 +/- 0.1% (10 microg), -0.6 +/- 0.1% (5 microg), and +0.2 +/- 0.1% (placebo; adjusted P < 0.0001 vs. placebo), yielding placebo-adjusted reductions of -1.0% (10 microg) and -0.8% (5 microg).
3 context sentences(design, population, supporting numbers)
Summary · context
A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks.
Summary · context
Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d.
Summary · context
Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
Report a problemFND-1585557102
03HumanRandomized controlled trialEfficacy outcome
In evaluable patients with type 2 diabetes, 34% receiving exenatide achieved A1C at or below 7% versus 9% with placebo.
In plain wordsMore evaluable patients reached the A1C target with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseA1C target attainment
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg twice daily for 4 weeks, then 10 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Measurements
Proportion reaching A1C <=7%
34%
exenatide 10 microg b.i.d., evaluable population
Proportion reaching A1C <=7%
9%
placebo, evaluable population
Source sentences
Summary
In the evaluable population, exenatide-treated subjects were more likely to achieve A1C < or =7% than placebo-treated subjects (34% [10 microg], 27% [5 microg], and 9% [placebo]; P < 0.0001).
3 context sentences(design, population, supporting numbers)
Summary · context
A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks.
Summary · context
Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d.
Summary · context
Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
Report a problemFND-1585557103
04HumanRandomized controlled trialEfficacy outcome
In evaluable patients with type 2 diabetes, 27% receiving exenatide achieved A1C at or below 7% versus 9% with placebo.
In plain wordsMore evaluable patients reached the A1C target with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseA1C target attainment
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Measurements
Proportion reaching A1C <=7%
27%
exenatide 5 microg b.i.d., evaluable population
Proportion reaching A1C <=7%
9%
placebo, evaluable population
Source sentences
Summary
In the evaluable population, exenatide-treated subjects were more likely to achieve A1C < or =7% than placebo-treated subjects (34% [10 microg], 27% [5 microg], and 9% [placebo]; P < 0.0001).
3 context sentences(design, population, supporting numbers)
Summary · context
A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks.
Summary · context
Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d.
Summary · context
Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
Report a problemFND-1585557104
05HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes on metformin and a sulfonylurea, weight fell by 1.6 kg from baseline with exenatide 10 microg b.i.d. and by 0.9 kg with placebo, a significant difference versus placebo.
In plain wordsWeight fell with exenatide and also with placebo, and the fall was larger with exenatide, in patients with type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
5 microg twice daily for 4 weeks, then 10 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Measurements
Weight change from baseline
−1.6 kg
exenatide 10 microg b.i.d., week 30 (SE 0.2)
Weight change from baseline
−0.9 kg
placebo (SE 0.2)
Source sentences
Summary
Both exenatide arms demonstrated significant weight loss (-1.6 +/- 0.2 kg from baseline each exenatide arm, -0.9 +/- 0.2 kg placebo; P < or = 0.01 vs. placebo).
3 context sentences(design, population, supporting numbers)
Summary · context
A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks.
Summary · context
Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d.
Summary · context
Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
Report a problemFND-1585557105
06HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes on metformin and a sulfonylurea, weight fell by 1.6 kg from baseline with exenatide 5 microg b.i.d. and by 0.9 kg with placebo, a significant difference versus placebo.
In plain wordsWeight fell with exenatide and also with placebo, and the fall was larger with exenatide, in patients with type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
5 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Measurements
Weight change from baseline
−1.6 kg
exenatide 5 microg b.i.d., week 30 (SE 0.2)
Weight change from baseline
−0.9 kg
placebo (SE 0.2)
Source sentences
Summary
Both exenatide arms demonstrated significant weight loss (-1.6 +/- 0.2 kg from baseline each exenatide arm, -0.9 +/- 0.2 kg placebo; P < or = 0.01 vs. placebo).
3 context sentences(design, population, supporting numbers)
Summary · context
A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks.
Summary · context
Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d.
Summary · context
Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
Report a problemFND-1585557106
07HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes in this placebo-controlled exenatide study, mild or moderate nausea was the most frequent adverse event.
In plain wordsIn this exenatide study in type 2 diabetes, mild or moderate nausea was the most frequent adverse event.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5 microg twice daily, or 5 microg for 4 weeks then 10 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
Mild or moderate nausea was the most frequent adverse event.
3 context sentences(design, population, supporting numbers)
Summary · context
A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks.
Summary · context
Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d.
Summary · context
Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
Report a problemFND-1585557107
08HumanRandomized controlled trialSafety outcome
In type 2 diabetes, mild or moderate hypoglycemia occurred in 28% with exenatide versus 13% with placebo.
In plain wordsLow blood sugar occurred in 28% with exenatide versus 13% with placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseMild or moderate hypoglycemia
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
5 microg twice daily for 4 weeks, then 10 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Measurements
Incidence of mild/moderate hypoglycemia
28%
exenatide 10 microg b.i.d.
Incidence of mild/moderate hypoglycemia
13%
placebo
Source sentences
Summary
The incidence of mild/moderate hypoglycemia was 28% (10 microg), 19% (5 microg), and 13% (placebo) and appeared lower with MIN than with MAX sulfonylurea treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks.
Summary · context
Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d.
Summary · context
Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
Report a problemFND-1585557108
09HumanRandomized controlled trialSafety outcome
In type 2 diabetes, mild or moderate hypoglycemia occurred in 19% with exenatide versus 13% with placebo.
In plain wordsLow blood sugar occurred in 19% with exenatide versus 13% with placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseMild or moderate hypoglycemia
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
5 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Measurements
Incidence of mild/moderate hypoglycemia
19%
exenatide 5 microg b.i.d.
Incidence of mild/moderate hypoglycemia
13%
placebo
Source sentences
Summary
The incidence of mild/moderate hypoglycemia was 28% (10 microg), 19% (5 microg), and 13% (placebo) and appeared lower with MIN than with MAX sulfonylurea treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks.
Summary · context
Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d.
Summary · context
Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea.
Report a problemFND-1585557109

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00035984

Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus

AstraZenecan = 734May 2002 to Aug 2003

Diabetes Mellitus, Non-Insulin-Dependent

Trial page ClinicalTrials.govUpdated 24 Feb 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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