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Study · Randomized controlled trial · n = 466 · 2009

7 results

Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea.

Gao Y, Yoon KH, Chuang LM, Mohan V, Ning G, Shah S, Jang HC, Wu TJ, Johns D, Northrup J, Brodows R

Diabetes research and clinical practice18 Nov 2008Cited by 69 (Europe PMC)

PMID19019476 (opens in a new tab)DOI10.1016/j.diabres.2008.09.037 (opens in a new tab)PepBankPUB-19019476
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 Asian patients with diabetes on metformin with or without sulphonylurea, exenatide reduced HbA1c more than placebo.

    In plain wordsIn Asian patients with diabetes, exenatide reduced HbA1c more than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHbA1c reduction
    Study

    n = 466

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 12 weeks · 16 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.2%
    exenatide
    HbA1c change
    −0.4%
    placebo

    Source sentences

    Summary
    Endpoint HbA(1c) reduction (mean [95% CI]) with exenatide was superior to placebo (-1.2 [-1.3, -1.1]% vs. -0.4 [-0.5, -0.2]%, p<0.001).
    2 context sentences
    Summary · context
    The primary endpoint was baseline to endpoint HbA(1c) change.
    Summary · context
    To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents.MethodsPatients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, r…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Asian patients with diabetes, more patients achieved HbA1c at or below 7% with exenatide than placebo.

    In plain wordsIn Asian patients with diabetes, more patients reached HbA1c at or below 7% with exenatide than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseHbA1c at or below 7%
    Study

    n = 466

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 12 weeks · 16 weeksAs given in this study (human).

    Measurements

    HbA1c at or below 7%
    48%
    exenatide
    HbA1c at or below 7%
    17%
    placebo

    Source sentences

    Summary
    More exenatide- than placebo-treated patients achieved HbA(1c) <or=7% (48% vs. 17%, p<0.001).
    1 context sentence
    Summary · context
    To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents.MethodsPatients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, r…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Asian patients with diabetes, exenatide reduced body weight more than placebo.

    In plain wordsIn Asian patients with diabetes, exenatide reduced body weight more than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseBody weight reduction
    Study

    n = 466

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 12 weeks · 16 weeksAs given in this study (human).

    Measurements

    Body weight change
    −1.2 kg
    exenatide
    Body weight change
    −0.1 kg
    placebo

    Source sentences

    Summary
    At endpoint, weight reduction was greater with exenatide (-1.2 [-1.5, -0.9]kg) than placebo (-0.1 [-0.3, 0.2]kg), p<0.001.
    1 context sentence
    Summary · context
    To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents.MethodsPatients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, r…
  4. 04HumanRandomized controlled trialSafety outcome

    In Asian patients with diabetes, generally mild-to-moderate nausea occurred in 25% with exenatide versus 1% with placebo.

    In plain wordsIn Asian patients with diabetes, nausea was generally mild to moderate and occurred more often with exenatide than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseNausea
    Study

    n = 466

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 12 weeks · 16 weeksAs given in this study (human).

    Measurements

    Nausea
    25%
    exenatide
    Nausea
    1%
    placebo

    Source sentences

    Summary
    Nausea, generally mild-to-moderate, was the most common adverse event with exenatide (25% vs. 1% with placebo).
    1 context sentence
    Summary · context
    To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents.MethodsPatients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, r…
  5. 05HumanRandomized controlled trialSafety outcome

    In Asian patients with diabetes, symptomatic hypoglycaemia was more frequent with exenatide than placebo.

    In plain wordsIn Asian patients with diabetes, symptomatic low blood glucose was more frequent with exenatide than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseSymptomatic hypoglycaemia
    Study

    n = 466

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 12 weeks · 16 weeksAs given in this study (human).

    Measurements

    Symptomatic hypoglycaemia
    36%
    exenatide
    Symptomatic hypoglycaemia
    9%
    placebo

    Source sentences

    Summary
    The incidence of symptomatic hypoglycaemia with exenatide and placebo were 36% and 9%, respectively (p<0.001).
    1 context sentence
    Summary · context
    To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents.MethodsPatients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, r…
  6. 06HumanRandomized controlled trialSafety outcome

    In Asian patients with diabetes taking exenatide and metformin, the hypoglycaemia rate was 1.8 events/patient-year.

    In plain wordsIn Asian patients with diabetes taking exenatide and metformin, low blood glucose occurred at 1.8 events/patient-year.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableHypoglycaemia rate with metformin
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 12 weeks · 16 weeksAs given in this study (human).

    Measurements

    Hypoglycaemia rate
    1.8 events/patient-year
    exenatide with MET

    Source sentences

    Summary
    Hypoglycaemia rates (events/patient-year) for patients taking exenatide with MET or MET and SU were 1.8 (0.9, 3.7) and 4.7 (3.5, 6.5), respectively.
    1 context sentence
    Summary · context
    To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents.MethodsPatients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, r…
  7. 07HumanRandomized controlled trialSafety outcome

    In Asian patients with diabetes taking exenatide, metformin and sulphonylurea, the hypoglycaemia rate was 4.7 events/patient-year.

    In plain wordsIn Asian patients with diabetes taking exenatide, metformin and sulphonylurea, low blood glucose occurred at 4.7 events/patient-year.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableHypoglycaemia rate with metformin and sulphonylurea
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 12 weeks · 16 weeksAs given in this study (human).

    Measurements

    Hypoglycaemia rate
    4.7 events/patient-year
    exenatide with MET and SU

    Source sentences

    Summary
    Hypoglycaemia rates (events/patient-year) for patients taking exenatide with MET or MET and SU were 1.8 (0.9, 3.7) and 4.7 (3.5, 6.5), respectively.
    1 context sentence
    Summary · context
    To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents.MethodsPatients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, r…

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00324363

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

AstraZenecan = 466Jan 2006 to Apr 2007

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 23 Feb 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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