Study · Randomized controlled trial · n = 377 · 2004

8 results

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

Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD

Diabetes care1 Nov 2004Cited by 890 (Europe PMC)

PMID15504997DOI10.2337/diacare.27.11.2628PepBankPUB-15504997

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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialSafety outcome
In sulfonylurea-treated patients with type 2 diabetes, the most frequent adverse events were generally mild or moderate and gastrointestinal.
In plain wordsIn patients with type 2 diabetes taking sulfonylureas, the most frequent adverse events were generally mild or moderate digestive symptoms.
Peptide
Exenatide (exendin-4)
Outcome
Direction not reportedGastrointestinal adverse events
Study
n = 377
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
The most frequent adverse events were generally mild or moderate and gastrointestinal in nature.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S.
Summary · context
All subjects continued sulfonylurea therapy.
Report a problemFND-1550499708
02HumanRandomized controlled trialSafety outcome
In the trial of exenatide in sulfonylurea-treated patients with type 2 diabetes, no severe hypoglycemia occurred.
In plain wordsIn the exenatide trial in patients taking sulfonylureas, no severe low blood sugar occurred.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSevere hypoglycemia
Study
n = 377
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · subcutaneous · 30 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycemia was observed.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S.
Summary · context
All subjects continued sulfonylurea therapy.
Report a problemFND-1550499709
03HumanRandomized controlled trialEfficacy outcome
In sulfonylurea-treated patients with type 2 diabetes, exenatide 10 microg reduced HbA1c versus placebo.
In plain wordsIn patients with type 2 diabetes taking sulfonylureas, exenatide 10 microg reduced HbA1c versus placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c 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
HbA1c change from baseline
−0.86%
10-microg arm
HbA1c change from baseline
0.12%
placebo arm
Source sentences
Summary
At week 30, HbA(1c) changes from baseline were -0.86 +/- 0.11, -0.46 +/- 0.12, and 0.12 +/- 0.09% (+/-SE) in the 10-microg, 5-microg, and placebo arms, respectively (adjusted P < 0.001).
4 context sentences(design, population, supporting numbers)
Summary · context
This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S.
Summary · context
After a 4-week, single-blind, placebo lead-in period, 377 subjects were randomized (60% men, age 55 +/- 11 years, BMI 33 +/- 6 kg/m(2), HbA(1c) 8.6 +/- 1.2% [+/-SD]) and began 4 weeks at 5 microg subcutaneous exenatide twice daily (before breakfast and dinner; arms A and B) or placebo.
Summary · context
Subsequently, subjects in arm B were escalated to 10 microg b.i.d. exenatide.
Summary · context
All subjects continued sulfonylurea therapy.
Report a problemFND-1550499701
04HumanRandomized controlled trialEfficacy outcome
In sulfonylurea-treated patients with type 2 diabetes, exenatide 5 microg reduced HbA1c versus placebo.
In plain wordsIn patients with type 2 diabetes taking sulfonylureas, exenatide 5 microg reduced HbA1c versus placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c 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
HbA1c change from baseline
−0.46%
5-microg arm
HbA1c change from baseline
0.12%
placebo arm
Source sentences
Summary
At week 30, HbA(1c) changes from baseline were -0.86 +/- 0.11, -0.46 +/- 0.12, and 0.12 +/- 0.09% (+/-SE) in the 10-microg, 5-microg, and placebo arms, respectively (adjusted P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S.
Summary · context
All subjects continued sulfonylurea therapy.
Report a problemFND-1550499702
05HumanRandomized controlled trialEfficacy outcome
Among evaluable patients with baseline HbA1c above 7%, 41% receiving exenatide 10 microg achieved HbA1c at most 7%, versus 9% with placebo.
In plain wordsIn evaluable patients with elevated HbA1c, exenatide 10 microg increased target attainment versus placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHbA1c target attainment
Study
n: not reported in source
Comparator
placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).
Measurements
Proportion achieving HbA1c <= 7%
41%
10-microg arm, baseline HbA1c > 7%
Proportion achieving HbA1c <= 7%
9%
placebo arm, baseline HbA1c > 7%
Source sentences
Summary
Of evaluable subjects with baseline HbA(1c) > 7% (n = 237), 41% (10 microg), 33% (5 microg), and 9% (placebo) achieved HbA(1c) <or= 7% (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S.
Summary · context
All subjects continued sulfonylurea therapy.
Report a problemFND-1550499703
06HumanRandomized controlled trialEfficacy outcome
Among evaluable patients with baseline HbA1c above 7%, 33% receiving exenatide 5 microg achieved HbA1c at most 7%, versus 9% with placebo.
In plain wordsIn evaluable patients with elevated HbA1c, exenatide 5 microg increased target attainment versus placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHbA1c 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 achieving HbA1c <= 7%
33%
5-microg arm, baseline HbA1c > 7%
Proportion achieving HbA1c <= 7%
9%
placebo arm, baseline HbA1c > 7%
Source sentences
Summary
Of evaluable subjects with baseline HbA(1c) > 7% (n = 237), 41% (10 microg), 33% (5 microg), and 9% (placebo) achieved HbA(1c) <or= 7% (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S.
Summary · context
All subjects continued sulfonylurea therapy.
Report a problemFND-1550499704
07HumanRandomized controlled trialEfficacy outcome
In sulfonylurea-treated patients with type 2 diabetes, exenatide 10 microg decreased fasting glucose versus placebo.
In plain wordsIn patients with type 2 diabetes taking sulfonylureas, exenatide 10 microg lowered fasting glucose versus placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose
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).
Source sentences
Summary
Fasting plasma glucose concentrations decreased in the 10-microg arm compared with placebo (P < 0.05).
4 context sentences(design, population, supporting numbers)
Summary · context
This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S.
Summary · context
After a 4-week, single-blind, placebo lead-in period, 377 subjects were randomized (60% men, age 55 +/- 11 years, BMI 33 +/- 6 kg/m(2), HbA(1c) 8.6 +/- 1.2% [+/-SD]) and began 4 weeks at 5 microg subcutaneous exenatide twice daily (before breakfast and dinner; arms A and B) or placebo.
Summary · context
Subsequently, subjects in arm B were escalated to 10 microg b.i.d. exenatide.
Summary · context
All subjects continued sulfonylurea therapy.
Report a problemFND-1550499705
08HumanRandomized controlled trialEfficacy outcome
In sulfonylurea-treated patients with type 2 diabetes, exenatide 10 microg reduced body weight versus placebo.
In plain wordsIn patients with type 2 diabetes taking sulfonylureas, exenatide 10 microg reduced weight versus placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
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
−1.6 kg
10-microg exenatide arm
Source sentences
Summary
Subjects in the exenatide arms had dose-dependent progressive weight loss, with an end-of-study loss in the 10-microg exenatide arm of -1.6 +/- 0.3 kg from baseline (P < 0.05 vs. placebo).
4 context sentences(design, population, supporting numbers)
Summary · context
This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S.
Summary · context
After a 4-week, single-blind, placebo lead-in period, 377 subjects were randomized (60% men, age 55 +/- 11 years, BMI 33 +/- 6 kg/m(2), HbA(1c) 8.6 +/- 1.2% [+/-SD]) and began 4 weeks at 5 microg subcutaneous exenatide twice daily (before breakfast and dinner; arms A and B) or placebo.
Summary · context
Subsequently, subjects in arm B were escalated to 10 microg b.i.d. exenatide.
Summary · context
All subjects continued sulfonylurea therapy.
Report a problemFND-1550499706

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

Registered trials3

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

3 trials · 3 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00856609

The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)n = 1503 Mar 2009 to 19 Sept 2016

Weight Loss · Obesity

Trial page ClinicalTrials.govUpdated 4 Jun 2019

CompletedPhase not statedNCT00569907

Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide

HealthPartners Instituten = 18Jan 2007 to May 2009

Diabetes Mellitus Type 2

Trial page ClinicalTrials.govUpdated 26 Nov 2015

CompletedPhase 3NCT00039026

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

AstraZenecan = 377Feb 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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