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Study · Randomized controlled trial · n = 326 · 2010

7 results

Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial.

Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE

Lancet (London, England)26 Jun 2010Cited by 457 (Europe PMC)

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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with type 2 diabetes, exenatide reduced HbA1c more than sitagliptin.

    In plain wordsIn patients with diabetes taking metformin, exenatide reduced HbA1c more than sitagliptin.

    Outcome
    DecreaseHbA1c versus sitagliptin
    Study

    n = 326

    Comparator
    Sitagliptin
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg once weekly · injection · 26 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.5%
    exenatide
    HbA1c change
    −0.9%
    sitagliptin
    HbA1c treatment difference
    −0.6%
    exenatide versus sitagliptin

    Source sentences

    Summary
    Treatment differences were -0.6% (95% CI -0.9 to -0.4, p<0.0001) for exenatide versus sitagliptin, and -0.3% (-0.6 to -0.1, p=0.0165) for exenatide versus pioglitazone.
    5 context sentences
    Summary · context
    Treatment with exenatide reduced HbA(1c) (least square mean -1.5%, 95% CI -1.7 to -1.4) significantly more than did sitagliptin (-0.9%, -1.1 to -0.7) or pioglitazone (-1.2%, -1.4 to -1.0).
    Summary · context
    Primary endpoint was change in HbA(1c) between baseline and week 26.
    Summary · context
    491 patients received at least one dose of study drug and were included in the intention-to-treat analysis (160 on exenatide, 166 on sitagliptin, and 165 on pioglitazone).
    Summary · context
    In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated with metformin, and at baseline had mean glycosylated haemoglobin (HbA(1c)) of 8.5% (SD 1.1), fasting plasma glucose of 9.1 mmol/L (2.6), and weight of 88.0 kg (20.1), were e…
    Summary · context
    Patients were randomly assigned to receive: 2 mg injected exenatide once weekly plus oral placebo once daily; 100 mg oral sitagliptin once daily plus injected placebo once weekly; or 45 mg oral pioglitazone once daily plus injected placebo once weekly.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with type 2 diabetes, exenatide reduced HbA1c more than pioglitazone.

    In plain wordsIn patients with diabetes taking metformin, exenatide reduced HbA1c more than pioglitazone.

    Outcome
    DecreaseHbA1c versus pioglitazone
    Study

    n = 325

    Comparator
    Pioglitazone
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg once weekly · injection · 26 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.5%
    exenatide
    HbA1c change
    −1.2%
    pioglitazone
    HbA1c treatment difference
    −0.3%
    exenatide versus pioglitazone

    Source sentences

    Summary
    Treatment differences were -0.6% (95% CI -0.9 to -0.4, p<0.0001) for exenatide versus sitagliptin, and -0.3% (-0.6 to -0.1, p=0.0165) for exenatide versus pioglitazone.
    5 context sentences
    Summary · context
    Treatment with exenatide reduced HbA(1c) (least square mean -1.5%, 95% CI -1.7 to -1.4) significantly more than did sitagliptin (-0.9%, -1.1 to -0.7) or pioglitazone (-1.2%, -1.4 to -1.0).
    Summary · context
    Primary endpoint was change in HbA(1c) between baseline and week 26.
    Summary · context
    491 patients received at least one dose of study drug and were included in the intention-to-treat analysis (160 on exenatide, 166 on sitagliptin, and 165 on pioglitazone).
    Summary · context
    In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated with metformin, and at baseline had mean glycosylated haemoglobin (HbA(1c)) of 8.5% (SD 1.1), fasting plasma glucose of 9.1 mmol/L (2.6), and weight of 88.0 kg (20.1), were e…
    Summary · context
    Patients were randomly assigned to receive: 2 mg injected exenatide once weekly plus oral placebo once daily; 100 mg oral sitagliptin once daily plus injected placebo once weekly; or 45 mg oral pioglitazone once daily plus injected placebo once weekly.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with type 2 diabetes, exenatide produced greater weight loss than sitagliptin.

    In plain wordsIn patients with diabetes taking metformin, exenatide produced greater weight loss than sitagliptin.

    Outcome
    DecreaseWeight versus sitagliptin
    Study

    n = 326

    Comparator
    Sitagliptin
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2 mg once weekly · injection · 26 weeksAs given in this study (human).

    Measurements

    Weight treatment difference
    −1.5 kg
    exenatide versus sitagliptin
    Weight change
    −2.3 kg
    exenatide

    Source sentences

    Summary
    Weight loss with exenatide (-2.3 kg, 95% CI-2.9 to -1.7) was significantly greater than with sitagliptin (difference -1.5 kg, 95% CI -2.4 to -0.7, p=0.0002) or pioglitazone (difference -5.1 kg, -5.9 to -4.3, p<0.0001).
    3 context sentences
    Summary · context
    491 patients received at least one dose of study drug and were included in the intention-to-treat analysis (160 on exenatide, 166 on sitagliptin, and 165 on pioglitazone).
    Summary · context
    In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated with metformin, and at baseline had mean glycosylated haemoglobin (HbA(1c)) of 8.5% (SD 1.1), fasting plasma glucose of 9.1 mmol/L (2.6), and weight of 88.0 kg (20.1), were e…
    Summary · context
    Patients were randomly assigned to receive: 2 mg injected exenatide once weekly plus oral placebo once daily; 100 mg oral sitagliptin once daily plus injected placebo once weekly; or 45 mg oral pioglitazone once daily plus injected placebo once weekly.
  4. 04HumanRandomized controlled trialSafety outcome

    In metformin-treated patients with type 2 diabetes, nausea occurred in 24% with exenatide versus 10% with sitagliptin.

    In plain wordsIn patients with diabetes taking metformin, nausea occurred in 24% with exenatide versus 10% with sitagliptin.

    Outcome
    IncreaseNausea versus sitagliptin
    Study

    n = 326

    Comparator
    Sitagliptin
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    2 mg once weekly · injection · 26 weeksAs given in this study (human).

    Measurements

    Nausea
    24%
    exenatide
    Nausea
    10%
    sitagliptin

    Source sentences

    Summary
    The most frequent adverse events with exenatide and sitagliptin were nausea (n=38, 24%, and n=16, 10%, respectively) and diarrhoea (n=29, 18%, and n=16, 10%, respectively);
    3 context sentences
    Summary · context
    491 patients received at least one dose of study drug and were included in the intention-to-treat analysis (160 on exenatide, 166 on sitagliptin, and 165 on pioglitazone).
    Summary · context
    In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated with metformin, and at baseline had mean glycosylated haemoglobin (HbA(1c)) of 8.5% (SD 1.1), fasting plasma glucose of 9.1 mmol/L (2.6), and weight of 88.0 kg (20.1), were e…
    Summary · context
    Patients were randomly assigned to receive: 2 mg injected exenatide once weekly plus oral placebo once daily; 100 mg oral sitagliptin once daily plus injected placebo once weekly; or 45 mg oral pioglitazone once daily plus injected placebo once weekly.
  5. 05HumanRandomized controlled trialSafety outcome

    In metformin-treated patients with type 2 diabetes, diarrhoea occurred in 18% with exenatide versus 10% with sitagliptin.

    In plain wordsIn patients with diabetes taking metformin, diarrhoea occurred in 18% with exenatide versus 10% with sitagliptin.

    Outcome
    IncreaseDiarrhoea versus sitagliptin
    Study

    n = 326

    Comparator
    Sitagliptin
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    2 mg once weekly · injection · 26 weeksAs given in this study (human).

    Measurements

    Diarrhoea
    18%
    exenatide
    Diarrhoea
    10%
    sitagliptin

    Source sentences

    Summary
    The most frequent adverse events with exenatide and sitagliptin were nausea (n=38, 24%, and n=16, 10%, respectively) and diarrhoea (n=29, 18%, and n=16, 10%, respectively);
    3 context sentences
    Summary · context
    491 patients received at least one dose of study drug and were included in the intention-to-treat analysis (160 on exenatide, 166 on sitagliptin, and 165 on pioglitazone).
    Summary · context
    In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated with metformin, and at baseline had mean glycosylated haemoglobin (HbA(1c)) of 8.5% (SD 1.1), fasting plasma glucose of 9.1 mmol/L (2.6), and weight of 88.0 kg (20.1), were e…
    Summary · context
    Patients were randomly assigned to receive: 2 mg injected exenatide once weekly plus oral placebo once daily; 100 mg oral sitagliptin once daily plus injected placebo once weekly; or 45 mg oral pioglitazone once daily plus injected placebo once weekly.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with type 2 diabetes, exenatide produced greater weight loss than pioglitazone.

    In plain wordsIn patients with diabetes taking metformin, exenatide produced greater weight loss than pioglitazone.

    Outcome
    DecreaseWeight versus pioglitazone
    Study

    n = 325

    Comparator
    Pioglitazone
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2 mg once weekly · injection · 26 weeksAs given in this study (human).

    Measurements

    Weight treatment difference
    −5.1 kg
    exenatide versus pioglitazone
    Weight change
    −2.3 kg
    exenatide

    Source sentences

    Summary
    Weight loss with exenatide (-2.3 kg, 95% CI-2.9 to -1.7) was significantly greater than with sitagliptin (difference -1.5 kg, 95% CI -2.4 to -0.7, p=0.0002) or pioglitazone (difference -5.1 kg, -5.9 to -4.3, p<0.0001).
    3 context sentences
    Summary · context
    491 patients received at least one dose of study drug and were included in the intention-to-treat analysis (160 on exenatide, 166 on sitagliptin, and 165 on pioglitazone).
    Summary · context
    In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated with metformin, and at baseline had mean glycosylated haemoglobin (HbA(1c)) of 8.5% (SD 1.1), fasting plasma glucose of 9.1 mmol/L (2.6), and weight of 88.0 kg (20.1), were e…
    Summary · context
    Patients were randomly assigned to receive: 2 mg injected exenatide once weekly plus oral placebo once daily; 100 mg oral sitagliptin once daily plus injected placebo once weekly; or 45 mg oral pioglitazone once daily plus injected placebo once weekly.
  7. 07HumanRandomized controlled trialSafety outcome

    In metformin-treated patients with type 2 diabetes, no major hypoglycaemia episodes occurred with exenatide.

    In plain wordsIn patients with diabetes taking metformin, no major low blood sugar episodes occurred with exenatide.

    Outcome
    Not applicableMajor hypoglycaemia
    Study

    n = 160

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    2 mg once weekly · injection · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    No episodes of major hypoglycaemia occurred.
    3 context sentences
    Summary · context
    491 patients received at least one dose of study drug and were included in the intention-to-treat analysis (160 on exenatide, 166 on sitagliptin, and 165 on pioglitazone).
    Summary · context
    In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated with metformin, and at baseline had mean glycosylated haemoglobin (HbA(1c)) of 8.5% (SD 1.1), fasting plasma glucose of 9.1 mmol/L (2.6), and weight of 88.0 kg (20.1), were e…
    Summary · context
    Patients were randomly assigned to receive: 2 mg injected exenatide once weekly plus oral placebo once daily; 100 mg oral sitagliptin once daily plus injected placebo once weekly; or 45 mg oral pioglitazone once daily plus injected placebo once weekly.

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

CompletedPhase 2Results postedNCT04431713

Exenatide Once-weekly as a Treatment for Multiple System Atrophy

University College, Londonn = 5016 Sept 2020 to 22 Mar 2024

Multiple System Atrophy

Trial pageClinicalTrials.govUpdated 27 Jun 2025
CompletedPhase 4NCT02380521

Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes

University of Palermon = 60Jan 2015 to Nov 2016

Type 2 Diabetes Mellitus

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

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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. 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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