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Study · Randomized controlled trial · 2007

12 results

The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes.

Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M

Diabetes technology & therapeutics1 Aug 2007Cited by 27 (Europe PMC)

PMID17705687 (opens in a new tab)DOI10.1089/dia.2006.0024 (opens in a new tab)PepBankPUB-17705687
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 study12

12 results from studies that gave the peptide. 12 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, exenatide monotherapy reduced A1C versus placebo.

    In plain wordsExenatide alone reduced blood sugar more than placebo in adults with diabetes.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseA1C
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    10 microg twice-daily · 28 daysAs given in this study (human).

    Measurements

    A1C change
    −0.4%
    exenatide
    A1C change
    0.2%
    placebo

    Source sentences

    Summary
    Monotherapeutic treatment with 10 microg of exenatide twice-daily for 28 days resulted in significant mean reductions in glycosylated hemoglobin (A1C) of -0.4 +/- 0.1% and fasting plasma glucose of -36.1 +/- 11.0 mg/dL compared to increases of +0.2 +/- 0.1% and +11.0 +/- 12.7 mg/dL with placebo.
    1 context sentence
    Summary · context
    Study A was a randomized, double-blind, placebo-controlled study of 99 patients with type 2 diabetes that received either 10 microg twice-daily, 10 microg once-daily, or 20 microg once-daily exenatide or placebo for 28 days in the absence of background pharmacotherapy.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, exenatide monotherapy reduced fasting plasma glucose versus placebo.

    In plain wordsExenatide alone reduced fasting blood sugar more than placebo in adults with diabetes.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseFasting plasma glucose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    10 microg twice-daily · 28 daysAs given in this study (human).

    Measurements

    Fasting glucose change
    −36.1 mg/dL
    exenatide
    Fasting glucose change
    11 mg/dL
    placebo

    Source sentences

    Summary
    Monotherapeutic treatment with 10 microg of exenatide twice-daily for 28 days resulted in significant mean reductions in glycosylated hemoglobin (A1C) of -0.4 +/- 0.1% and fasting plasma glucose of -36.1 +/- 11.0 mg/dL compared to increases of +0.2 +/- 0.1% and +11.0 +/- 12.7 mg/dL with placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, exenatide reduced daily blood glucose versus placebo.

    In plain wordsExenatide reduced daily blood sugar more than placebo in adults with diabetes.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseDaily blood glucose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 28 daysAs given in this study (human).

    Source sentences

    Summary
    Self-monitored blood glucose profiles showed significant mean reductions in daily blood glucose concentrations in exenatide-treated patients compared to placebo.
  4. 04HumanNon-randomized trialEfficacy outcome

    In adults treated with diet and exercise, A1C decreased from baseline during open-label exenatide.

    In plain wordsBlood sugar decreased from baseline in adults receiving exenatide with diet and exercise.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseA1C diet and exercise subgroup
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice-daily for 4 weeks followed by 10 microg for 26 weeks · 30 weeksAs given in this study (human).

    Measurements

    A1C change
    −1%
    diet and exercise subgroup

    Source sentences

    Summary
    Exenatide treatment for 30 weeks in an open-label extension study resulted in similar mean reductions from baseline in A1C and body weight in patients treated with diet and exercise alone (-1.0 +/- 0.2% and -4.3 +/- 1.3 kg, respectively) as those treated on a background of metformin (-0.9 +/- 0.1% a…
  5. 05HumanNon-randomized trialEfficacy outcome

    In adults treated with diet and exercise, weight decreased from baseline during open-label exenatide.

    In plain wordsWeight decreased from baseline in adults receiving exenatide with diet and exercise.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseWeight diet and exercise subgroup
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 microg twice-daily for 4 weeks followed by 10 microg for 26 weeks · 30 weeksAs given in this study (human).

    Measurements

    Weight change
    −4.3 kg
    diet and exercise subgroup

    Source sentences

    Summary
    Exenatide treatment for 30 weeks in an open-label extension study resulted in similar mean reductions from baseline in A1C and body weight in patients treated with diet and exercise alone (-1.0 +/- 0.2% and -4.3 +/- 1.3 kg, respectively) as those treated on a background of metformin (-0.9 +/- 0.1% a…
  6. 06HumanNon-randomized trialEfficacy outcome

    In adults continuing metformin, A1C decreased from baseline during open-label exenatide.

    In plain wordsBlood sugar decreased from baseline in adults receiving exenatide while continuing metformin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseA1C metformin subgroup
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice-daily for 4 weeks followed by 10 microg for 26 weeks · 30 weeksAs given in this study (human).

    Measurements

    A1C change
    −0.9%
    metformin subgroup

    Source sentences

    Summary
    Exenatide treatment for 30 weeks in an open-label extension study resulted in similar mean reductions from baseline in A1C and body weight in patients treated with diet and exercise alone (-1.0 +/- 0.2% and -4.3 +/- 1.3 kg, respectively) as those treated on a background of metformin (-0.9 +/- 0.1% a…
  7. 07HumanNon-randomized trialEfficacy outcome

    In adults continuing metformin, weight decreased from baseline during open-label exenatide.

    In plain wordsWeight decreased from baseline in adults receiving exenatide while continuing metformin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseWeight metformin subgroup
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 microg twice-daily for 4 weeks followed by 10 microg for 26 weeks · 30 weeksAs given in this study (human).

    Measurements

    Weight change
    −3.7 kg
    metformin subgroup

    Source sentences

    Summary
    Exenatide treatment for 30 weeks in an open-label extension study resulted in similar mean reductions from baseline in A1C and body weight in patients treated with diet and exercise alone (-1.0 +/- 0.2% and -4.3 +/- 1.3 kg, respectively) as those treated on a background of metformin (-0.9 +/- 0.1% a…
  8. 08HumanNon-randomized trialEfficacy outcome

    In the open-label exenatide extension, A1C reductions were similar with diet and exercise alone and with background metformin.

    In plain wordsBlood sugar reductions during exenatide treatment were similar with diet and exercise alone and with background metformin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeA1C change by background treatment
    Study

    n: not reported in source

    Comparator
    Exenatide with background metformin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice-daily for 4 weeks followed by 10 microg for 26 weeks · 30 weeksAs given in this study (human).

    Measurements

    A1C change
    −1%
    diet and exercise alone
    A1C change
    −0.9%
    background metformin

    Source sentences

    Summary
    Exenatide treatment for 30 weeks in an open-label extension study resulted in similar mean reductions from baseline in A1C and body weight in patients treated with diet and exercise alone (-1.0 +/- 0.2% and -4.3 +/- 1.3 kg, respectively) as those treated on a background of metformin (-0.9 +/- 0.1% a…
    1 context sentence
    Summary · context
    Study B was an open-label extension of a short-term study of 127 patients with type 2 diabetes treated with metformin or diet and exercise. Patients received exenatide 5 microg twice-daily for 4 weeks followed by 10 microg for 26 weeks. Subjects treated with metformin continued oral therapy.
  9. 09HumanNon-randomized trialEfficacy outcome

    In the open-label exenatide extension, weight reductions were similar with diet and exercise alone and with background metformin.

    In plain wordsWeight reductions during exenatide treatment were similar with diet and exercise alone and with background metformin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeWeight change by background treatment
    Study

    n: not reported in source

    Comparator
    Exenatide with background metformin
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 microg twice-daily for 4 weeks followed by 10 microg for 26 weeks · 30 weeksAs given in this study (human).

    Measurements

    Weight change
    −4.3 kg
    diet and exercise alone
    Weight change
    −3.7 kg
    background metformin

    Source sentences

    Summary
    Exenatide treatment for 30 weeks in an open-label extension study resulted in similar mean reductions from baseline in A1C and body weight in patients treated with diet and exercise alone (-1.0 +/- 0.2% and -4.3 +/- 1.3 kg, respectively) as those treated on a background of metformin (-0.9 +/- 0.1% a…
    1 context sentence
    Summary · context
    Study B was an open-label extension of a short-term study of 127 patients with type 2 diabetes treated with metformin or diet and exercise. Patients received exenatide 5 microg twice-daily for 4 weeks followed by 10 microg for 26 weeks. Subjects treated with metformin continued oral therapy.
  10. 10HumanOther designSafety outcome

    Across both exenatide studies, gastrointestinal events predominated and were mostly mild to moderate.

    In plain wordsDigestive side effects were most frequent and mostly mild to moderate across both exenatide studies.

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

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In both studies, the most frequent adverse events were gastrointestinal and predominantly mild to moderate in intensity.
  11. 11HumanOther designSafety outcome

    Across the exenatide studies, mild-to-moderate hypoglycemia incidence was low.

    In plain wordsMild-to-moderate low blood sugar was uncommon across the exenatide studies.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableMild-to-moderate hypoglycemia
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Incidence of mild-to-moderate hypoglycemia was low, with no severe hypoglycemia.
  12. 12HumanOther designSafety outcome

    The exenatide studies reported no severe hypoglycemia.

    In plain wordsThe exenatide studies reported no severe low blood sugar.

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

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Incidence of mild-to-moderate hypoglycemia was low, with no severe hypoglycemia.

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

CompletedPhase 2NCT00085969

Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

AstraZenecan = 99Sept 2003 to Jan 2004

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 23 Feb 2015
CompletedPhase 3NCT00111540

Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

AstraZenecan = 456Nov 2002 to Sept 2006

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 23 Feb 2015
CompletedPhase 2NCT00044694

Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus

AstraZenecan = 156Aug 2002 to May 2003

Diabetes Mellitus, Non-Insulin-Dependent

Trial pageClinicalTrials.govUpdated 20 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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