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Study · Randomized controlled trial · n = 165 · 2010

7 results

A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin.

Liutkus J, Rosas Guzman J, Norwood P, Pop L, Northrup J, Cao D, Trautmann M

Diabetes, obesity & metabolism1 Dec 2010Cited by 58 (Europe PMC)

PMID20977576 (opens in a new tab)DOI10.1111/j.1463-1326.2010.01251.x (opens in a new tab)PepBankPUB-20977576
Publisher pagePubMedAsk about this study
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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 patients with inadequately controlled diabetes on TZDs with or without metformin, exenatide reduced HbA1c more than placebo.

    In plain wordsIn patients with diabetes on TZDs with or without metformin, exenatide reduced HbA1c more than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHbA1c change
    Study

    n = 165

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −0.84%
    exenatide
    HbA1c change
    −0.1%
    placebo
    HbA1c treatment difference
    −0.74%
    exenatide versus placebo

    Source sentences

    Summary
    Exenatide reduced HbA(1c) significantly more than placebo [-0.84% (s.e. 0.20) vs. -0.10% (0.23), treatment difference -0.74% (0.16), p < 0.001)].
    3 context sentences
    Summary · context
    The primary endpoint was HbA(1c) change at endpoint (Week 26 or last-observation-carried-forward).
    Summary · context
    A 26-week, multi-country (Canada, Mexico, Romania, South Africa and the USA), randomized, double-blind, placebo-controlled study compared exenatide twice-daily vs. placebo in 165 subjects suboptimally controlled with TZDs with or without metformin
    Summary · context
    After a 2-week, single-blind, lead-in period, subjects were randomly assigned (2 : 1) to add exenatide or placebo to current regimens.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, weight reductions were similar with exenatide and placebo on background TZDs with or without metformin.

    In plain wordsIn patients with diabetes, weight loss was similar with exenatide and placebo on background TZDs with or without metformin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeBody weight change
    Study

    n = 165

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    Body weight change
    −1.4 kg
    exenatide
    Body weight change
    −0.8 kg
    placebo

    Source sentences

    Summary
    Mean reductions in body weight were similar in both treatments at endpoint [exenatide, -1.4 (s.e. 0.6) kg vs. placebo, -0.8 (0.7) kg, p = 0.176)].
    2 context sentences
    Summary · context
    A 26-week, multi-country (Canada, Mexico, Romania, South Africa and the USA), randomized, double-blind, placebo-controlled study compared exenatide twice-daily vs. placebo in 165 subjects suboptimally controlled with TZDs with or without metformin
    Summary · context
    After a 2-week, single-blind, lead-in period, subjects were randomly assigned (2 : 1) to add exenatide or placebo to current regimens.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, nearly 71% receiving exenatide reduced both HbA1c and weight versus 54% receiving placebo.

    In plain wordsIn patients with diabetes, nearly 71% reduced both HbA1c and weight with exenatide versus 54% with placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseConcurrent HbA1c and body weight reduction
    Study

    n = 165

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    Concurrent HbA1c and weight reduction
    ≈ 71%
    exenatide
    Concurrent HbA1c and weight reduction
    54%
    placebo

    Source sentences

    Summary
    Nearly 71% of subjects had both a reduction in HbA(1c) and body weight with exenatide compared with 54% with placebo.
    2 context sentences
    Summary · context
    A 26-week, multi-country (Canada, Mexico, Romania, South Africa and the USA), randomized, double-blind, placebo-controlled study compared exenatide twice-daily vs. placebo in 165 subjects suboptimally controlled with TZDs with or without metformin
    Summary · context
    After a 2-week, single-blind, lead-in period, subjects were randomly assigned (2 : 1) to add exenatide or placebo to current regimens.
  4. 04HumanRandomized controlled trialSafety outcome

    In patients with diabetes, nausea was more frequent with exenatide than placebo.

    In plain wordsIn patients with diabetes, nausea was more frequent with exenatide than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseNausea
    Study

    n = 165

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    Nausea
    12%
    exenatide
    Nausea
    2%
    placebo

    Source sentences

    Summary
    The most common adverse events (exenatide vs. placebo) were nausea (12% vs. 2%, p = 0.037), vomiting (8% vs. 0%, p = 0.031) and headache (4% vs. 4%).
    2 context sentences
    Summary · context
    A 26-week, multi-country (Canada, Mexico, Romania, South Africa and the USA), randomized, double-blind, placebo-controlled study compared exenatide twice-daily vs. placebo in 165 subjects suboptimally controlled with TZDs with or without metformin
    Summary · context
    After a 2-week, single-blind, lead-in period, subjects were randomly assigned (2 : 1) to add exenatide or placebo to current regimens.
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with diabetes, vomiting was more frequent with exenatide than placebo.

    In plain wordsIn patients with diabetes, vomiting was more frequent with exenatide than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseVomiting
    Study

    n = 165

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    Vomiting
    8%
    exenatide
    Vomiting
    0%
    placebo

    Source sentences

    Summary
    The most common adverse events (exenatide vs. placebo) were nausea (12% vs. 2%, p = 0.037), vomiting (8% vs. 0%, p = 0.031) and headache (4% vs. 4%).
    2 context sentences
    Summary · context
    A 26-week, multi-country (Canada, Mexico, Romania, South Africa and the USA), randomized, double-blind, placebo-controlled study compared exenatide twice-daily vs. placebo in 165 subjects suboptimally controlled with TZDs with or without metformin
    Summary · context
    After a 2-week, single-blind, lead-in period, subjects were randomly assigned (2 : 1) to add exenatide or placebo to current regimens.
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with diabetes, headache occurred in equal proportions with exenatide and placebo.

    In plain wordsIn patients with diabetes, headache occurred at the same rate with exenatide and placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeHeadache
    Study

    n = 165

    Comparator
    Placebo
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    Headache
    4%
    exenatide
    Headache
    4%
    placebo

    Source sentences

    Summary
    The most common adverse events (exenatide vs. placebo) were nausea (12% vs. 2%, p = 0.037), vomiting (8% vs. 0%, p = 0.031) and headache (4% vs. 4%).
    2 context sentences
    Summary · context
    A 26-week, multi-country (Canada, Mexico, Romania, South Africa and the USA), randomized, double-blind, placebo-controlled study compared exenatide twice-daily vs. placebo in 165 subjects suboptimally controlled with TZDs with or without metformin
    Summary · context
    After a 2-week, single-blind, lead-in period, subjects were randomly assigned (2 : 1) to add exenatide or placebo to current regimens.
  7. 07HumanRandomized controlled trialSafety outcome

    In patients with diabetes, confirmed minor hypoglycaemia occurred in 4% with exenatide versus 2% with placebo, without a significant between-group difference.

    In plain wordsIn patients with diabetes, low blood glucose occurred in 4% with exenatide versus 2% with placebo, without a significant difference.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeConfirmed minor hypoglycaemia
    Study

    n = 165

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    Confirmed minor hypoglycaemia
    4%
    exenatide
    Confirmed minor hypoglycaemia
    2%
    placebo

    Source sentences

    Summary
    Confirmed (blood glucose <3.0 mmol/l) minor hypoglycaemia was experienced by 4 and 2% of subjects treated with exenatide and placebo, respectively. Incidence of hypoglycaemia was not significantly different between groups.
    2 context sentences
    Summary · context
    A 26-week, multi-country (Canada, Mexico, Romania, South Africa and the USA), randomized, double-blind, placebo-controlled study compared exenatide twice-daily vs. placebo in 165 subjects suboptimally controlled with TZDs with or without metformin
    Summary · context
    After a 2-week, single-blind, lead-in period, subjects were randomly assigned (2 : 1) to add exenatide or placebo to current regimens.

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 postedNCT00603239

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

AstraZenecan = 165Jan 2008 to Jul 2009

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.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.

  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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