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Study · Randomized controlled trial · 2005

9 results

Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes.

DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD

Diabetes care1 May 2005Cited by 1,048 (Europe PMC)

PMID15855572 (opens in a new tab)DOI10.2337/diacare.28.5.1092 (opens in a new tab)PepBankPUB-15855572
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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, exenatide reduced HbA1c by 0.78% from baseline versus a 0.08% increase with placebo.

    In plain wordsExenatide reduced HbA1c more than placebo in patients with type 2 diabetes.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHbA1c change
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 26 weeks · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    HbA1c change from baseline
    −0.78%
    exenatide 10 microg b.i.d., week 30, ITT (SE 0.10)
    HbA1c change from baseline
    0.08%
    placebo, week 30, ITT (SE 0.10)

    Source sentences

    Summary
    At week 30, HbA(1c) changes from baseline +/- SE for each group were -0.78 +/- 0.10% (10 microg), -0.40 +/- 0.11% (5 microg), and +0.08 +/- 0.10% (placebo; intent to treat; adjusted P < 0.002).
    3 context sentences
    Summary · context
    A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients.
    Summary · context
    After 4 weeks of placebo, subjects self-administered 5 microg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 microg exenatide, or placebo subcutaneously twice daily for 26 weeks.
    Summary · context
    All subjects continued metformin therapy.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, exenatide reduced HbA1c by 0.40% from baseline versus a 0.08% increase with placebo.

    In plain wordsExenatide reduced HbA1c more than placebo in patients with type 2 diabetes.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHbA1c change
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    HbA1c change from baseline
    −0.4%
    exenatide 5 microg b.i.d., week 30, ITT (SE 0.11)
    HbA1c change from baseline
    0.08%
    placebo, week 30, ITT (SE 0.10)

    Source sentences

    Summary
    At week 30, HbA(1c) changes from baseline +/- SE for each group were -0.78 +/- 0.10% (10 microg), -0.40 +/- 0.11% (5 microg), and +0.08 +/- 0.10% (placebo; intent to treat; adjusted P < 0.002).
    3 context sentences
    Summary · context
    A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients.
    Summary · context
    After 4 weeks of placebo, subjects self-administered 5 microg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 microg exenatide, or placebo subcutaneously twice daily for 26 weeks.
    Summary · context
    All subjects continued metformin therapy.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In evaluable patients with type 2 diabetes, 46% receiving exenatide reached HbA1c at or below 7% versus 13% with placebo.

    In plain wordsMore evaluable patients reached the HbA1c target with exenatide than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseHbA1c target attainment
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 26 weeks · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    Proportion reaching HbA1c <=7%
    46%
    exenatide 10 microg b.i.d., evaluable subjects
    Proportion reaching HbA1c <=7%
    13%
    placebo, evaluable subjects

    Source sentences

    Summary
    Of evaluable subjects, 46% (10 microg), 32% (5 microg), and 13% (placebo) achieved HbA(1c) < or =7% (P < 0.01 vs. placebo).
    3 context sentences
    Summary · context
    A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients.
    Summary · context
    After 4 weeks of placebo, subjects self-administered 5 microg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 microg exenatide, or placebo subcutaneously twice daily for 26 weeks.
    Summary · context
    All subjects continued metformin therapy.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In evaluable patients with type 2 diabetes, 32% receiving exenatide reached HbA1c at or below 7% versus 13% with placebo.

    In plain wordsMore evaluable patients reached the HbA1c target with exenatide than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseHbA1c target attainment
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    Proportion reaching HbA1c <=7%
    32%
    exenatide 5 microg b.i.d., evaluable subjects
    Proportion reaching HbA1c <=7%
    13%
    placebo, evaluable subjects

    Source sentences

    Summary
    Of evaluable subjects, 46% (10 microg), 32% (5 microg), and 13% (placebo) achieved HbA(1c) < or =7% (P < 0.01 vs. placebo).
    3 context sentences
    Summary · context
    A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients.
    Summary · context
    After 4 weeks of placebo, subjects self-administered 5 microg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 microg exenatide, or placebo subcutaneously twice daily for 26 weeks.
    Summary · context
    All subjects continued metformin therapy.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, exenatide reduced weight by 2.8 kg, significantly more than placebo.

    In plain wordsPatients with type 2 diabetes lost more weight with exenatide than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseWeight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 10 microg twice daily for 26 weeks · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    Weight change
    −2.8 kg
    exenatide 10 microg b.i.d. (SE 0.5), P < 0.001 vs placebo

    Source sentences

    Summary
    Exenatide-treated subjects displayed progressive dose-dependent weight loss (-2.8 +/- 0.5 kg [10 microg], -1.6 +/- 0.4 kg [5 microg]; P < 0.001 vs. placebo).
    3 context sentences
    Summary · context
    A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients.
    Summary · context
    After 4 weeks of placebo, subjects self-administered 5 microg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 microg exenatide, or placebo subcutaneously twice daily for 26 weeks.
    Summary · context
    All subjects continued metformin therapy.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, exenatide reduced weight by 1.6 kg, significantly more than placebo.

    In plain wordsPatients with type 2 diabetes lost more weight with exenatide than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseWeight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 microg twice daily · subcutaneous · 30 weeksAs given in this study (human).

    Measurements

    Weight change
    −1.6 kg
    exenatide 5 microg b.i.d. (SE 0.4), P < 0.001 vs placebo

    Source sentences

    Summary
    Exenatide-treated subjects displayed progressive dose-dependent weight loss (-2.8 +/- 0.5 kg [10 microg], -1.6 +/- 0.4 kg [5 microg]; P < 0.001 vs. placebo).
    3 context sentences
    Summary · context
    A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients.
    Summary · context
    After 4 weeks of placebo, subjects self-administered 5 microg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 microg exenatide, or placebo subcutaneously twice daily for 26 weeks.
    Summary · context
    All subjects continued metformin therapy.
  7. 07HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes in this placebo-controlled exenatide study, the most frequent adverse events were gastrointestinal and generally mild to moderate.

    In plain wordsIn this exenatide study in type 2 diabetes, the most frequent adverse events were mild to moderate digestive symptoms.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableGastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5 microg twice daily for 4 weeks, then 5 or 10 microg twice daily for 26 weeks · subcutaneous · 30 weeksAs given in this study (human).

    Source sentences

    Summary
    The most frequent adverse events were gastrointestinal in nature and generally mild to moderate.
    3 context sentences
    Summary · context
    A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients.
    Summary · context
    After 4 weeks of placebo, subjects self-administered 5 microg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 microg exenatide, or placebo subcutaneously twice daily for 26 weeks.
    Summary · context
    All subjects continued metformin therapy.
  8. 08HumanRandomized controlled trialSafety outcome

    In type 2 diabetes, mild to moderate hypoglycemia was low and similar across exenatide and placebo arms.

    In plain wordsMild to moderate low blood sugar was similarly uncommon with exenatide and placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeMild to moderate hypoglycemia
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 5 or 10 microg twice daily for 26 weeks · subcutaneous · 30 weeksAs given in this study (human).

    Source sentences

    Summary
    Incidence of mild to moderate hypoglycemia was low and similar across treatment arms, with no severe hypoglycemia.
    3 context sentences
    Summary · context
    A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients.
    Summary · context
    After 4 weeks of placebo, subjects self-administered 5 microg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 microg exenatide, or placebo subcutaneously twice daily for 26 weeks.
    Summary · context
    All subjects continued metformin therapy.
  9. 09HumanRandomized controlled trialSafety outcome

    In type 2 diabetes, no severe hypoglycemia occurred across treatment arms, including exenatide.

    In plain wordsNo severe low blood sugar occurred in any treatment arm, including exenatide.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableSevere hypoglycemia
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    5 microg twice daily for 4 weeks, then 5 or 10 microg twice daily for 26 weeks · subcutaneous · 30 weeksAs given in this study (human).

    Source sentences

    Summary
    Incidence of mild to moderate hypoglycemia was low and similar across treatment arms, with no severe hypoglycemia.
    3 context sentences
    Summary · context
    A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients.
    Summary · context
    After 4 weeks of placebo, subjects self-administered 5 microg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 microg exenatide, or placebo subcutaneously twice daily for 26 weeks.
    Summary · context
    All subjects continued metformin therapy.

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

CompletedPhase not statedNCT00569907

Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide

HealthPartners Instituten = 18Jan 2007 to May 2009

Diabetes Mellitus Type 2

Trial pageClinicalTrials.govUpdated 26 Nov 2015
CompletedPhase 3NCT00039013

Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

AstraZenecan = 336Mar 2002 to Jun 2003

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 24 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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