Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study.

Russell-Jones D, Cuddihy RM, Hanefeld M, Kumar A, González JG, Chan M, Wolka AM, Boardman MK

Diabetes care30 Dec 2011Cited by 273 (Europe PMC)

PMID22210563PMCIDPMC3263915DOI10.2337/dc11-1107PepBankPUB-22210563

Read at source 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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study10

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

01HumanRandomized controlled trialSafety outcome
In patients with diabetes, nausea occurred in 11.3% with exenatide.
In plain wordsIn patients with diabetes, nausea occurred in 11.3% with exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea
Study
n = 248
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Nausea incidence
11.3%
exenatide once weekly arm
Source sentences
Summary
EQW, nausea (11.3%) and diarrhea (10.9%);
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056307
02HumanRandomized controlled trialSafety outcome
In patients with diabetes, diarrhea occurred in 10.9% with exenatide.
In plain wordsIn patients with diabetes, diarrhea occurred in 10.9% with exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableDiarrhea
Study
n = 248
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Diarrhea incidence
10.9%
exenatide once weekly arm
Source sentences
Summary
EQW, nausea (11.3%) and diarrhea (10.9%);
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056308
03HumanRandomized controlled trialEfficacy outcome
In drug-naive patients with diabetes, HbA1c reductions with exenatide and metformin did not differ significantly.
In plain wordsIn patients with diabetes, exenatide and metformin produced similar HbA1c reductions.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c versus metformin
Study
n: not reported in source
Comparator
Metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
HbA1c reduction
−1.53%
exenatide once weekly, 26 weeks (LS mean)
HbA1c reduction
−1.48%
metformin, 26 weeks (LS mean)
Source sentences
Summary
HbA(1c) reductions (%) at 26 weeks (least-squares means) with EQW versus MET, PIO, and SITA were -1.53 vs. -1.48 (P = 0.620), -1.63 (P = 0.328), and -1.15 (P < 0.001), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056301
04HumanRandomized controlled trialEfficacy outcome
In drug-naive patients with diabetes, HbA1c reductions with exenatide and pioglitazone did not differ significantly.
In plain wordsIn patients with diabetes, HbA1c reductions did not differ significantly between exenatide and pioglitazone.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c versus pioglitazone
Study
n: not reported in source
Comparator
Pioglitazone
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
HbA1c reduction
−1.53%
exenatide once weekly, 26 weeks (LS mean)
HbA1c reduction
−1.63%
pioglitazone, 26 weeks (LS mean)
Source sentences
Summary
HbA(1c) reductions (%) at 26 weeks (least-squares means) with EQW versus MET, PIO, and SITA were -1.53 vs. -1.48 (P = 0.620), -1.63 (P = 0.328), and -1.15 (P < 0.001), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056302
05HumanRandomized controlled trialEfficacy outcome
In drug-naive patients with diabetes, exenatide reduced HbA1c more than sitagliptin.
In plain wordsIn patients with diabetes, exenatide reduced HbA1c more than sitagliptin.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c versus sitagliptin
Study
n: not reported in source
Comparator
Sitagliptin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
HbA1c reduction
−1.53%
exenatide once weekly, 26 weeks (LS mean)
HbA1c reduction
−1.15%
sitagliptin, 26 weeks (LS mean)
Source sentences
Summary
HbA(1c) reductions (%) at 26 weeks (least-squares means) with EQW versus MET, PIO, and SITA were -1.53 vs. -1.48 (P = 0.620), -1.63 (P = 0.328), and -1.15 (P < 0.001), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056303
06HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, weight changes with exenatide and metformin did not differ significantly.
In plain wordsIn patients with diabetes, exenatide and metformin produced similar weight changes.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeWeight versus metformin
Study
n: not reported in source
Comparator
Metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Weight change
−2 kg
exenatide once weekly, 26 weeks
Weight change
−2 kg
metformin, 26 weeks
Source sentences
Summary
Weight changes (kg) were -2.0 vs. -2.0 (P = 0.892), +1.5 (P < 0.001), and -0.8 (P < 0.001), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056304
07HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, exenatide reduced weight compared with pioglitazone.
In plain wordsIn patients with diabetes, exenatide reduced weight compared with pioglitazone.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight versus pioglitazone
Study
n: not reported in source
Comparator
Pioglitazone
Outcome group
Body weight · Metabolic and weight
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Weight change
−2 kg
exenatide once weekly, 26 weeks
Weight change
1.5 kg
pioglitazone, 26 weeks
Source sentences
Summary
Weight changes (kg) were -2.0 vs. -2.0 (P = 0.892), +1.5 (P < 0.001), and -0.8 (P < 0.001), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056305
08HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, exenatide reduced weight more than sitagliptin.
In plain wordsIn patients with diabetes, exenatide reduced weight more than sitagliptin.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight versus sitagliptin
Study
n: not reported in source
Comparator
Sitagliptin
Outcome group
Body weight · Metabolic and weight
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Weight change
−2 kg
exenatide once weekly, 26 weeks
Weight change
−0.8 kg
sitagliptin, 26 weeks
Source sentences
Summary
Weight changes (kg) were -2.0 vs. -2.0 (P = 0.892), +1.5 (P < 0.001), and -0.8 (P < 0.001), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056306
09HumanRandomized controlled trialSafety outcome
In the diabetes trial including exenatide, confirmed minor hypoglycemia was rare.
In plain wordsIn the diabetes trial including exenatide, confirmed minor hypoglycemia was rare.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMinor hypoglycemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
Minor (confirmed) hypoglycemia was rarely reported.
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056309
10HumanRandomized controlled trialSafety outcome
In the diabetes trial including exenatide, no major hypoglycemia occurred.
In plain wordsIn the diabetes trial including exenatide, no major hypoglycemia occurred.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMajor hypoglycemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
2.0 mg weekly · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
No major hypoglycemia occurred.
2 context sentences(design, population, supporting numbers)
Summary · context
To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes.
Summary · context
Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks.
Report a problemFND-2221056310

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

Registered trials2

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

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT02380521

Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes

University of Palermon = 60Jan 2015 to Nov 2016

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 8 Nov 2016

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

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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