Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial.

Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG

Annals of internal medicine1 Oct 2005Cited by 548 (Europe PMC)

PMID16230722DOI10.7326/0003-4819-143-8-200510180-00006PepBankPUB-16230722

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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide and insulin glargine both reduced HbA1c by 1.11%, with a between-group difference of 0.017 percentage point.
In plain wordsExenatide and insulin glargine reduced HbA1c similarly in patients with type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c reduction
Study
n = 551
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
HbA1c reduction at week 26
1.11%
exenatide and insulin glargine, each arm
Between-group difference in HbA1c
0.017 percentage point
95% CI -0.123 to 0.157
Source sentences
Summary
At week 26, both exenatide and insulin glargine reduced hemoglobin A1c levels by 1.11% (difference, 0.017 percentage point [95% CI, -0.123 to 0.157 percentage point]).
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072201
02HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced postprandial glucose excursions more than insulin glargine.
In plain wordsExenatide reduced after-meal blood sugar rises more than insulin glargine in patients with type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePostprandial glucose excursions
Study
n = 551
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Source sentences
Summary
Exenatide reduced postprandial glucose excursions more than insulin glargine, while insulin glargine reduced fasting glucose concentrations more than exenatide.
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072202
03HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, exenatide reduced fasting glucose less than insulin glargine.
In plain wordsExenatide reduced fasting blood sugar less than insulin glargine in patients with type 2 diabetes.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseFasting glucose concentration
Study
n = 551
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Source sentences
Summary
Exenatide reduced postprandial glucose excursions more than insulin glargine, while insulin glargine reduced fasting glucose concentrations more than exenatide.
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072203
04HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, weight decreased 2.3 kg with exenatide and increased 1.8 kg with insulin glargine.
In plain wordsPatients lost weight with exenatide but gained weight with insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change
Study
n = 551
Comparator
Insulin glargine
Outcome group
Body weight · Metabolic and weight
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
Change in body weight
−2.3 kg
exenatide, week 26
Change in body weight
1.8 kg
insulin glargine, week 26
Between-group difference in body weight
−4.1 kg
CI -4.6 to -3.5 kg
Source sentences
Summary
Body weight decreased 2.3 kg with exenatide and increased 1.8 kg with insulin glargine (difference, -4.1 kg [CI, -4.6 to -3.5 kg]).
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072204
05HumanRandomized controlled trialSafety outcome
In type 2 diabetes, symptomatic hypoglycemia rates were similar with exenatide and insulin glargine.
In plain wordsSymptomatic low blood sugar occurred at similar rates with exenatide and insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSymptomatic hypoglycemia
Study
n = 551
Comparator
Insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Source sentences
Summary
Rates of symptomatic hypoglycemia were similar, but nocturnal hypoglycemia occurred less frequently with exenatide (0.9 event/patient-year versus 2.4 events/patient-year; difference, -1.6 events/patient-year [CI, -2.3 to -0.9 event/patient year]).
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072205
06HumanRandomized controlled trialSafety outcome
In type 2 diabetes, nocturnal hypoglycemia occurred less frequently with exenatide than insulin glargine, at 0.9 versus 2.4 events/patient-year.
In plain wordsNighttime low blood sugar occurred less often with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseNocturnal hypoglycemia
Study
n = 551
Comparator
Insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
Nocturnal hypoglycemia rate
0.9 events/patient-year
exenatide
Nocturnal hypoglycemia rate
2.4 events/patient-year
insulin glargine
Between-group difference in nocturnal hypoglycemia rate
−1.6 events/patient-year
CI -2.3 to -0.9
Source sentences
Summary
Rates of symptomatic hypoglycemia were similar, but nocturnal hypoglycemia occurred less frequently with exenatide (0.9 event/patient-year versus 2.4 events/patient-year; difference, -1.6 events/patient-year [CI, -2.3 to -0.9 event/patient year]).
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072206
07HumanRandomized controlled trialSafety outcome
In type 2 diabetes, nausea occurred in 57.1% with exenatide versus 8.6% with insulin glargine.
In plain wordsNausea occurred more often with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseNausea
Study
n = 551
Comparator
Insulin glargine
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
Nausea incidence
57.1%
exenatide
Nausea incidence
8.6%
insulin glargine
Source sentences
Summary
Gastrointestinal symptoms were more common in the exenatide group than in the insulin glargine group, including nausea (57.1% vs. 8.6%), vomiting (17.4% vs. 3.7%) and diarrhea (8.5% vs. 3.0%).
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072207
08HumanRandomized controlled trialSafety outcome
In type 2 diabetes, vomiting occurred in 17.4% with exenatide versus 3.7% with insulin glargine.
In plain wordsVomiting occurred more often with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseVomiting
Study
n = 551
Comparator
Insulin glargine
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
Vomiting incidence
17.4%
exenatide
Vomiting incidence
3.7%
insulin glargine
Source sentences
Summary
Gastrointestinal symptoms were more common in the exenatide group than in the insulin glargine group, including nausea (57.1% vs. 8.6%), vomiting (17.4% vs. 3.7%) and diarrhea (8.5% vs. 3.0%).
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072208
09HumanRandomized controlled trialSafety outcome
In type 2 diabetes, diarrhea occurred in 8.5% with exenatide versus 3.0% with insulin glargine.
In plain wordsDiarrhea occurred more often with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseDiarrhea
Study
n = 551
Comparator
Insulin glargine
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
Diarrhea incidence
8.5%
exenatide
Diarrhea incidence
3%
insulin glargine
Source sentences
Summary
Gastrointestinal symptoms were more common in the exenatide group than in the insulin glargine group, including nausea (57.1% vs. 8.6%), vomiting (17.4% vs. 3.7%) and diarrhea (8.5% vs. 3.0%).
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072209
10HumanRandomized controlled trialSafety outcome
In type 2 diabetes, 19.4% receiving exenatide withdrew versus 9.7% receiving insulin glargine.
In plain wordsMore patients withdrew with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseStudy withdrawal
Study
n = 551
Comparator
Insulin glargine
Outcome group
Adverse events · Whole body
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
Study withdrawal
19.4%
exenatide
Study withdrawal
9.7%
insulin glargine
Source sentences
Summary
Of the 551 participants, 19.4% of those receiving exenatide and 9.7% of those receiving insulin glargine withdrew from the study.
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072210
11HumanRandomized controlled trialEfficacy outcome
In type 2 diabetes, 8.6% receiving exenatide reached the fasting glucose target versus 21.6% receiving insulin glargine.
In plain wordsFewer patients reached the fasting blood sugar target with exenatide than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting glucose target attainment
Study
n = 551
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 microg twice daily · 26 weeksAs given in this study (human).
Measurements
Patients reaching fasting plasma glucose target <5.6 mmol/L
8.6%
exenatide
Patients reaching fasting plasma glucose target <5.6 mmol/L
21.6%
insulin glargine
Source sentences
Summary
Only 21.6% of the insulin glargine group and 8.6% of the exenatide group achieved the target level for fasting plasma glucose of less than 5.6 mmol/L (<100 mg/dL).
3 context sentences(design, population, supporting numbers)
Summary · context
26-week multicenter, open-label, randomized, controlled trial.
Summary · context
551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy.
Summary · context
Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL).
Report a problemFND-1623072211

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

CompletedPhase 3Results postedNCT00082381

Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

AstraZenecan = 551Jun 2003 to Jul 2008

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 7 Apr 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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