Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial.

Buse JB, Bergenstal RM, Glass LC, Heilmann CR, Lewis MS, Kwan AY, Hoogwerf BJ, Rosenstock J

Annals of internal medicine6 Dec 2010Cited by 389 (Europe PMC)

PMID21138825DOI10.7326/0003-4819-154-2-201101180-00300PepBankPUB-21138825

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 study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In insulin glargine-treated adults with type 2 diabetes, exenatide reduced HbA1c more than placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, exenatide reduced long-term blood sugar more than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n: not reported in source
Comparator
placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Measurements
HbA1c change
−1.74%
exenatide
HbA1c change
−1.04%
placebo
Between-group difference
−0.69%
HbA1c
95% CI
−0.93 to −0.46%
between-group HbA1c difference
Source sentences
Summary
The HbA₁(c) level decreased by 1.74% with exenatide and 1.04% with placebo (between-group difference, -0.69% [95% CI, -0.93% to -0.46%]; P < 0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome was change in HbA₁(c) level.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882501
02HumanRandomized controlled trialEfficacy outcome
In insulin glargine-treated adults with type 2 diabetes, exenatide reduced weight compared with placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, exenatide reduced weight compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change
Study
n: not reported in source
Comparator
placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Measurements
Weight change
−1.8 kg
exenatide
Weight change
1 kg
placebo
Between-group difference
−2.7 kg
weight
CI
−3.7 to −1.7 kg
between-group weight difference
Source sentences
Summary
Weight decreased by 1.8 kg with exenatide and increased by 1.0 kg with placebo (between-group difference, -2.7 kg [CI, -3.7 to -1.7]).
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the percentage of participants with HbA₁(c) values of 7.0% or less and 6.5% or less, 7-point self-monitored glucose profiles, body weight, waist circumference, insulin dose, hypoglycemia, and adverse events.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882502
03HumanRandomized controlled trialEfficacy outcome
In insulin glargine-treated adults with type 2 diabetes, insulin dosage increased less with exenatide than placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, insulin doses increased less with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseInsulin dosage increase
Study
n: not reported in source
Comparator
placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Measurements
Insulin dosage increase
13 U/d
exenatide
Insulin dosage increase
20 U/d
placebo
Source sentences
Summary
Average increases in insulin dosage with exenatide and placebo were 13 U/d and 20 U/d.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the percentage of participants with HbA₁(c) values of 7.0% or less and 6.5% or less, 7-point self-monitored glucose profiles, body weight, waist circumference, insulin dose, hypoglycemia, and adverse events.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882503
04HumanRandomized controlled trialSafety outcome
In insulin glargine-treated adults with type 2 diabetes, minor hypoglycemia rates were similar with exenatide and placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, minor low blood sugar rates were similar with exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeMinor hypoglycemia
Study
n: not reported in source
Comparator
placebo
Analysis
Secondary
Outcome group
Adverse events · Metabolic and weight
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Source sentences
Summary
The estimated rate of minor hypoglycemia was similar between groups.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the percentage of participants with HbA₁(c) values of 7.0% or less and 6.5% or less, 7-point self-monitored glucose profiles, body weight, waist circumference, insulin dose, hypoglycemia, and adverse events.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882504
05HumanRandomized controlled trialSafety outcome
In insulin glargine-treated adults with type 2 diabetes, adverse-event discontinuations were more frequent with exenatide than placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, more patients stopped exenatide than placebo because of adverse events.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseDiscontinuation due to adverse events
Study
n: not reported in source
Comparator
placebo
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Measurements
Adverse-event discontinuations
13 patients
exenatide
Adverse-event discontinuations
1 patients
placebo
Source sentences
Summary
Thirteen exenatide recipients and 1 placebo recipient discontinued the study because of adverse events (P < 0.010);
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the percentage of participants with HbA₁(c) values of 7.0% or less and 6.5% or less, 7-point self-monitored glucose profiles, body weight, waist circumference, insulin dose, hypoglycemia, and adverse events.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882505
06HumanRandomized controlled trialSafety outcome
In insulin glargine-treated adults with type 2 diabetes, nausea was more frequent with exenatide than placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, nausea was more frequent with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseNausea
Study
n: not reported in source
Comparator
placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Measurements
Nausea
41%
exenatide
Nausea
8%
placebo
Source sentences
Summary
rates of nausea (41% vs. 8%), diarrhea (18% vs. 8%), vomiting (18% vs. 4%), headache (14% vs. 4%), and constipation (10% vs. 2%) were higher with exenatide than with placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the percentage of participants with HbA₁(c) values of 7.0% or less and 6.5% or less, 7-point self-monitored glucose profiles, body weight, waist circumference, insulin dose, hypoglycemia, and adverse events.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882506
07HumanRandomized controlled trialSafety outcome
In insulin glargine-treated adults with type 2 diabetes, diarrhea was more frequent with exenatide than placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, diarrhea was more frequent with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseDiarrhea
Study
n: not reported in source
Comparator
placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Measurements
Diarrhea
18%
exenatide
Diarrhea
8%
placebo
Source sentences
Summary
rates of nausea (41% vs. 8%), diarrhea (18% vs. 8%), vomiting (18% vs. 4%), headache (14% vs. 4%), and constipation (10% vs. 2%) were higher with exenatide than with placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the percentage of participants with HbA₁(c) values of 7.0% or less and 6.5% or less, 7-point self-monitored glucose profiles, body weight, waist circumference, insulin dose, hypoglycemia, and adverse events.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882507
08HumanRandomized controlled trialSafety outcome
In insulin glargine-treated adults with type 2 diabetes, vomiting was more frequent with exenatide than placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, vomiting was more frequent with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseVomiting
Study
n: not reported in source
Comparator
placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Measurements
Vomiting
18%
exenatide
Vomiting
4%
placebo
Source sentences
Summary
rates of nausea (41% vs. 8%), diarrhea (18% vs. 8%), vomiting (18% vs. 4%), headache (14% vs. 4%), and constipation (10% vs. 2%) were higher with exenatide than with placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the percentage of participants with HbA₁(c) values of 7.0% or less and 6.5% or less, 7-point self-monitored glucose profiles, body weight, waist circumference, insulin dose, hypoglycemia, and adverse events.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882508
09HumanRandomized controlled trialSafety outcome
In insulin glargine-treated adults with type 2 diabetes, headache was more frequent with exenatide than placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, headache was more frequent with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHeadache
Study
n: not reported in source
Comparator
placebo
Analysis
Secondary
Outcome group
Adverse events · Nervous system and cognition
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Measurements
Headache
14%
exenatide
Headache
4%
placebo
Source sentences
Summary
rates of nausea (41% vs. 8%), diarrhea (18% vs. 8%), vomiting (18% vs. 4%), headache (14% vs. 4%), and constipation (10% vs. 2%) were higher with exenatide than with placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the percentage of participants with HbA₁(c) values of 7.0% or less and 6.5% or less, 7-point self-monitored glucose profiles, body weight, waist circumference, insulin dose, hypoglycemia, and adverse events.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882509
10HumanRandomized controlled trialSafety outcome
In insulin glargine-treated adults with type 2 diabetes, constipation was more frequent with exenatide than placebo.
In plain wordsIn adults with type 2 diabetes receiving insulin glargine, constipation was more frequent with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseConstipation
Study
n: not reported in source
Comparator
placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
10 µg twice daily · injection · 30 weeksAs given in this study (human).
Measurements
Constipation
10%
exenatide
Constipation
2%
placebo
Source sentences
Summary
rates of nausea (41% vs. 8%), diarrhea (18% vs. 8%), vomiting (18% vs. 4%), headache (14% vs. 4%), and constipation (10% vs. 2%) were higher with exenatide than with placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the percentage of participants with HbA₁(c) values of 7.0% or less and 6.5% or less, 7-point self-monitored glucose profiles, body weight, waist circumference, insulin dose, hypoglycemia, and adverse events.
Summary · context
Adults with type 2 diabetes and an HbA₁(c) level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents).
Summary · context
Assignment by a centralized, computer-generated, random-sequence interactive voice-response system to exenatide, 10 µg twice daily, or placebo for 30 weeks.
Report a problemFND-2113882510

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 postedNCT00765817

Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

AstraZenecan = 261Oct 2008 to Jan 2010

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 24 Oct 2016

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

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