Study · Non-randomized trial · n = 1,379 · 2013

16 results

Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.

Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J

Postgraduate medicine1 May 2013Cited by 52 (Europe PMC)

PMID23748506DOI10.3810/pgm.2013.05.2660PepBankPUB-23748506

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 study16

16 results from studies that gave the peptide. 16 results from people.

01HumanNon-randomized trialEfficacy outcome
In patients with diabetes, weekly exenatide reduced HbA1c by 1.4% from baseline.
In plain wordsIn patients with diabetes, HbA1c fell from baseline with weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c
Study
n = 1,379
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Measurements
HbA1c change
−1.4%
ITT population
Source sentences
Summary
The ITT population experienced significant reductions from baseline (least-squares mean [95% CI]) in HbA1c levels (-1.4% [-1.5% to -1.4%]), fasting blood glucose levels (-36 mg/dL [-38.4 mg/dL to -33.8 mg/dL]), and body weight (-2.5 kg [-2.8 kg to -2.3 kg]) after 24 to 30 weeks of EQW treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850601
02HumanNon-randomized trialEfficacy outcome
In patients with diabetes, weekly exenatide reduced fasting blood glucose by 36 mg/dL from baseline.
In plain wordsIn patients with diabetes, fasting blood glucose fell from baseline with weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting blood glucose
Study
n = 1,379
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Measurements
Fasting blood glucose change
−36 mg/dL
ITT population
Source sentences
Summary
The ITT population experienced significant reductions from baseline (least-squares mean [95% CI]) in HbA1c levels (-1.4% [-1.5% to -1.4%]), fasting blood glucose levels (-36 mg/dL [-38.4 mg/dL to -33.8 mg/dL]), and body weight (-2.5 kg [-2.8 kg to -2.3 kg]) after 24 to 30 weeks of EQW treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850602
03HumanNon-randomized trialEfficacy outcome
In patients with diabetes, weekly exenatide reduced body weight by 2.5 kg from baseline.
In plain wordsIn patients with diabetes, body weight fell from baseline with weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n = 1,379
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Measurements
Body weight change
−2.5 kg
ITT population
Source sentences
Summary
The ITT population experienced significant reductions from baseline (least-squares mean [95% CI]) in HbA1c levels (-1.4% [-1.5% to -1.4%]), fasting blood glucose levels (-36 mg/dL [-38.4 mg/dL to -33.8 mg/dL]), and body weight (-2.5 kg [-2.8 kg to -2.3 kg]) after 24 to 30 weeks of EQW treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850603
04HumanNon-randomized trialEfficacy outcome
In patients with diabetes, weekly exenatide was associated with a systolic blood pressure reduction of 2.8 mm Hg from baseline.
In plain wordsIn patients with diabetes, systolic blood pressure fell from baseline with weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseSystolic blood pressure
Study
n = 1,379
Outcome group
Blood pressure · Cardiovascular
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Measurements
Systolic blood pressure change
−2.8 mm Hg
weekly exenatide
Source sentences
Summary
Treatment with EQW was associated with modest, significant reductions in blood pressure (systolic blood pressure, -2.8 mm Hg [-3.5 mm Hg to -2.1 mm Hg]; diastolic blood pressure, -0.8 mm Hg [-1.2 mm Hg to -0.4 mm Hg])
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850606
05HumanNon-randomized trialEfficacy outcome
In patients with diabetes, weekly exenatide was associated with a diastolic blood pressure reduction of 0.8 mm Hg from baseline.
In plain wordsIn patients with diabetes, diastolic blood pressure fell from baseline with weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseDiastolic blood pressure
Study
n = 1,379
Outcome group
Blood pressure · Cardiovascular
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Measurements
Diastolic blood pressure change
−0.8 mm Hg
weekly exenatide
Source sentences
Summary
Treatment with EQW was associated with modest, significant reductions in blood pressure (systolic blood pressure, -2.8 mm Hg [-3.5 mm Hg to -2.1 mm Hg]; diastolic blood pressure, -0.8 mm Hg [-1.2 mm Hg to -0.4 mm Hg])
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850607
06HumanNon-randomized trialEfficacy outcome
In patients with diabetes, weekly exenatide was associated with a total cholesterol reduction of 6.5 mg/dL from baseline.
In plain wordsIn patients with diabetes, total cholesterol fell from baseline with weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseTotal cholesterol
Study
n = 1,379
Outcome group
Lipids · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Measurements
Total cholesterol change
−6.5 mg/dL
weekly exenatide
Source sentences
Summary
and fasting lipid levels (total cholesterol, -6.5 mg/dL [-8.2 mg/dL to -4.7 mg/dL]
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850608
07HumanNon-randomized trialEfficacy outcome
In patients with diabetes, weekly exenatide was associated with a LDL cholesterol reduction of 3.9 mg/dL from baseline.
In plain wordsIn patients with diabetes, LDL cholesterol fell from baseline with weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseLDL cholesterol
Study
n = 1,379
Outcome group
Lipids · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Measurements
LDL cholesterol change
−3.9 mg/dL
weekly exenatide
Source sentences
Summary
and fasting lipid levels (total cholesterol, -6.5 mg/dL [-8.2 mg/dL to -4.7 mg/dL]; low-density lipoprotein cholesterol, -3.9 mg/dL [5.3 mg/dL to -2.5 mg/dL]
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850609
08HumanNon-randomized trialEfficacy outcome
In patients with diabetes, weekly exenatide was associated with a triglyceride reduction of 6% from baseline.
In plain wordsIn patients with diabetes, triglycerides fell from baseline with weekly exenatide.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseTriglycerides
Study
n = 1,379
Outcome group
Lipids · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Measurements
Triglyceride change
−6%
weekly exenatide
Source sentences
Summary
and triglyceride [geometric least-squares mean percent change (95% CI)], -6% [-8% to -4%] levels).
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850610
09HumanNon-randomized trialSafety outcome
In patients with diabetes, weekly exenatide was generally well tolerated.
In plain wordsIn patients with diabetes, weekly exenatide was generally well tolerated.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableTolerability
Study
n = 1,379
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Source sentences
Summary
Exenatide once weekly was generally well tolerated.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850612
10HumanNon-randomized trialSafety outcome
In patients receiving weekly exenatide, transient mild-to-moderate gastrointestinal events were among the most frequently reported events but seldom limited treatment.
In plain wordsIn patients receiving weekly exenatide, digestive events were among the most reported adverse events but seldom limited treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableGastrointestinal adverse events
Study
n = 1,379
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Source sentences
Summary
Transient, mild-to-moderate gastrointestinal treatment-emergent adverse events and injection-site treatment-emergent adverse events were reported most frequently, but were seldom treatment limiting.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850613
11HumanNon-randomized trialSafety outcome
In patients receiving weekly exenatide, injection-site events were among the most frequently reported adverse events but seldom limited treatment.
In plain wordsIn patients receiving weekly exenatide, injection-site events were among the most reported adverse events but seldom limited treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableInjection-site adverse events
Study
n = 1,379
Outcome group
Adverse events · Skin and wound
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Source sentences
Summary
Transient, mild-to-moderate gastrointestinal treatment-emergent adverse events and injection-site treatment-emergent adverse events were reported most frequently, but were seldom treatment limiting.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850614
12HumanNon-randomized trialSafety outcome
In patients receiving weekly exenatide, no major hypoglycemic events occurred.
In plain wordsIn patients receiving weekly exenatide, no major low blood sugar events occurred.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMajor hypoglycemic events
Study
n = 1,379
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Source sentences
Summary
No major hypoglycemic events were observed; minor hypoglycemic events occurred infrequently in patients not using a sulfonylurea.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850615
13HumanNon-randomized trialEfficacy outcome
In 1195 exenatide-treated completers, reductions were similar to those in the intent-to-treat population.
In plain wordsIn patients completing weekly exenatide treatment, reductions resembled those in the full treatment population.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseEfficacy reductions in completers
Study
n = 1,195
Outcome group
Overall treatment effect · Whole body
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Source sentences
Summary
Similar reductions were observed in the completer population.
4 context sentences(design, population, supporting numbers)
Summary · context
The ITT population experienced significant reductions from baseline (least-squares mean [95% CI]) in HbA1c levels (-1.4% [-1.5% to -1.4%]), fasting blood glucose levels (-36 mg/dL [-38.4 mg/dL to -33.8 mg/dL]), and body weight (-2.5 kg [-2.8 kg to -2.3 kg]) after 24 to 30 weeks of EQW treatment.
Summary · context
Changes from baseline in efficacy parameters for the ITT population and a completer population (1195 patients with ≥ 22 weeks of exposure) were evaluated.
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850611
14HumanNon-randomized trialEfficacy outcome
In patients receiving weekly exenatide, HbA1c decreased across baseline strata, with greater reductions at higher baseline HbA1c.
In plain wordsIn patients receiving weekly exenatide, HbA1c fell more when starting HbA1c was higher.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c by baseline stratum
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Source sentences
Summary
Reductions in HbA1c and fasting blood glucose levels were observed across baseline HbA1c level strata; patients with higher baseline HbA1c levels experienced greater reductions.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850604
15HumanNon-randomized trialEfficacy outcome
In patients receiving weekly exenatide, fasting glucose decreased across baseline HbA1c strata, with greater reductions at higher baseline HbA1c.
In plain wordsIn patients receiving weekly exenatide, fasting glucose fell more when starting HbA1c was higher.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting glucose by baseline HbA1c stratum
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Source sentences
Summary
Reductions in HbA1c and fasting blood glucose levels were observed across baseline HbA1c level strata; patients with higher baseline HbA1c levels experienced greater reductions.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850605
16HumanNon-randomized trialSafety outcome
In patients receiving weekly exenatide without sulfonylureas, minor hypoglycemic events occurred infrequently.
In plain wordsIn patients receiving weekly exenatide without sulfonylureas, minor low blood sugar events were uncommon.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMinor hypoglycemic events without sulfonylurea
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 24 to 30 weeksAs given in this study (human).
Source sentences
Summary
No major hypoglycemic events were observed; minor hypoglycemic events occurred infrequently in patients not using a sulfonylurea.
2 context sentences(design, population, supporting numbers)
Summary · context
This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population.
Summary · context
The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks.
Report a problemFND-2374850616

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

Registered trials6

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

6 trials · 6 completed · 6 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01029886

Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

AstraZenecan = 912Jan 2010 to Apr 2011

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 9 Apr 2015

CompletedPhase 3Results postedNCT00877890

A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

AstraZenecan = 254Mar 2009 to Jan 2010

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 7 Apr 2015

CompletedPhase 3Results postedNCT00676338

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

AstraZenecan = 820Nov 2008 to Jan 2011

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 9 Apr 2015

CompletedPhase 3Results postedNCT00641056

Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)

AstraZenecan = 467Apr 2008 to Nov 2009

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 15 Jun 2015

CompletedPhase 3Results postedNCT00637273

A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

AstraZenecan = 514Jan 2008 to Jul 2009

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 7 Apr 2015

CompletedPhase 3Results postedNCT00308139

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

AstraZenecan = 303Apr 2006 to Aug 2014

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 26 Aug 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

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