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Study · Randomized controlled trial · 2010

12 results

Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with Type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled trial.

Ratner RE, Rosenstock J, Boka G

Diabetic medicine : a journal of the British Diabetic Association1 Sept 2010Cited by 115 (Europe PMC)

Summary

AimsTo evaluate the dose-response relationship of lixisenatide (AVE0010), a glucagon-like peptide-1 (GLP-1) receptor agonist, in metformin-treated patients with Type 2 diabetes.MethodsRandomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo. The primary end-point was change in HbA(1c) from baseline to 13 weeks in the intent-to-treat population.ResultsLixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo). Target HbA(1c) < 7.0% (53 mmol/mol) at study end was achieved in 68% of patients receiving 20 and 30 microg once-daily lixisenatide vs. 32% receiving placebo (P < 0.0001). Dose-dependent improvements were observed for fasting, postprandial and average self-monitored seven-point blood glucose levels. Weight changes ranged from -2.0 to -3.9 kg with lixisenatide vs. -1.9 kg with placebo. The most frequent adverse event was mild-to-moderate nausea.ConclusionsLixisenatide significantly improved glycaemic control in mildly hyperglycaemic patients with Type 2 diabetes on metformin. Dose-response relationships were seen for once- and twice-daily regimens, with similar efficacy levels, with a 20 microg once-daily dose of lixisenatide demonstrating the best efficacy-to-tolerability ratio. This new, once-daily GLP-1 receptor agonist shows promise in the management of Type 2 diabetes to be defined further by ongoing long-term studies.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study12

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, lixisenatide reduced HbA1c by 0.47% (5.1 mmol/mol) versus 0.18% (2.0 mmol/mol) with placebo (P < 0.01).

    In plain wordsLixisenatide reduced HbA1c more than placebo in metformin-treated patients with diabetes.

    Outcome
    DecreaseHbA1c change, 5 microg once daily
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg once daily · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    Mean HbA1c reduction
    0.47%
    lixisenatide 5 microg once daily
    Mean HbA1c reduction
    5.1 mmol/mol
    lixisenatide 5 microg once daily
    Mean HbA1c reduction
    0.18%
    placebo
    Mean HbA1c reduction
    2 mmol/mol
    placebo

    Source sentences

    Summary
    Lixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo).
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, lixisenatide reduced HbA1c by 0.50% (5.5 mmol/mol) versus 0.18% (2.0 mmol/mol) with placebo (P < 0.01).

    In plain wordsLixisenatide reduced HbA1c more than placebo in metformin-treated patients with diabetes.

    Outcome
    DecreaseHbA1c change, 10 microg once daily
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    10 microg once daily · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    mean HbA1c reduction from baseline
    0.5%
    lixisenatide 10 microg once daily
    mean HbA1c reduction from baseline
    5.5 mmol/mol
    lixisenatide 10 microg once daily
    mean HbA1c reduction from baseline
    0.18%
    placebo
    mean HbA1c reduction from baseline
    2 mmol/mol
    placebo

    Source sentences

    Summary
    Lixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo).
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, lixisenatide reduced HbA1c by 0.69% (7.5 mmol/mol) versus 0.18% (2.0 mmol/mol) with placebo (P < 0.01).

    In plain wordsLixisenatide reduced HbA1c more than placebo in metformin-treated patients with diabetes.

    Outcome
    DecreaseHbA1c change, 20 microg once daily
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 microg once daily · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    mean HbA1c reduction from baseline
    0.69%
    lixisenatide 20 microg once daily
    mean HbA1c reduction from baseline
    7.5 mmol/mol
    lixisenatide 20 microg once daily
    mean HbA1c reduction from baseline
    0.18%
    placebo
    mean HbA1c reduction from baseline
    2 mmol/mol
    placebo

    Source sentences

    Summary
    Lixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo).
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, lixisenatide reduced HbA1c by 0.76% (8.3 mmol/mol) versus 0.18% (2.0 mmol/mol) with placebo (P < 0.01).

    In plain wordsLixisenatide reduced HbA1c more than placebo in metformin-treated patients with diabetes.

    Outcome
    DecreaseHbA1c change, 30 microg once daily
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    30 microg once daily · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    mean HbA1c reduction from baseline
    0.76%
    lixisenatide 30 microg once daily
    mean HbA1c reduction from baseline
    8.3 mmol/mol
    lixisenatide 30 microg once daily
    mean HbA1c reduction from baseline
    0.18%
    placebo
    mean HbA1c reduction from baseline
    2 mmol/mol
    placebo

    Source sentences

    Summary
    Lixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo).
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, lixisenatide reduced HbA1c by 0.65% (7.1 mmol/mol) versus 0.18% (2.0 mmol/mol) with placebo (P < 0.01).

    In plain wordsLixisenatide reduced HbA1c more than placebo in metformin-treated patients with diabetes.

    Outcome
    DecreaseHbA1c change, 5 microg twice daily
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 microg twice daily · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    mean HbA1c reduction from baseline
    0.65%
    lixisenatide 5 microg twice daily
    mean HbA1c reduction from baseline
    7.1 mmol/mol
    lixisenatide 5 microg twice daily
    mean HbA1c reduction from baseline
    0.18%
    placebo
    mean HbA1c reduction from baseline
    2 mmol/mol
    placebo

    Source sentences

    Summary
    Lixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo).
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, lixisenatide reduced HbA1c by 0.78% (8.5 mmol/mol) versus 0.18% (2.0 mmol/mol) with placebo (P < 0.01).

    In plain wordsLixisenatide reduced HbA1c more than placebo in metformin-treated patients with diabetes.

    Outcome
    DecreaseHbA1c change, 10 microg twice daily
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    10 microg twice daily · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    mean HbA1c reduction from baseline
    0.78%
    lixisenatide 10 microg twice daily
    mean HbA1c reduction from baseline
    8.5 mmol/mol
    lixisenatide 10 microg twice daily
    mean HbA1c reduction from baseline
    0.18%
    placebo
    mean HbA1c reduction from baseline
    2 mmol/mol
    placebo

    Source sentences

    Summary
    Lixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo).
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, lixisenatide reduced HbA1c by 0.75% (8.2 mmol/mol) versus 0.18% (2.0 mmol/mol) with placebo (P < 0.01).

    In plain wordsLixisenatide reduced HbA1c more than placebo in metformin-treated patients with diabetes.

    Outcome
    DecreaseHbA1c change, 20 microg twice daily
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 microg twice daily · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    mean HbA1c reduction from baseline
    0.75%
    lixisenatide 20 microg twice daily
    mean HbA1c reduction from baseline
    8.2 mmol/mol
    lixisenatide 20 microg twice daily
    mean HbA1c reduction from baseline
    0.18%
    placebo
    mean HbA1c reduction from baseline
    2 mmol/mol
    placebo

    Source sentences

    Summary
    Lixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo).
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, lixisenatide reduced HbA1c by 0.87% (9.5 mmol/mol) versus 0.18% (2.0 mmol/mol) with placebo (P < 0.01).

    In plain wordsLixisenatide reduced HbA1c more than placebo in metformin-treated patients with diabetes.

    Outcome
    DecreaseHbA1c change, 30 microg twice daily
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    30 microg twice daily · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    mean HbA1c reduction from baseline
    0.87%
    lixisenatide 30 microg twice daily
    mean HbA1c reduction from baseline
    9.5 mmol/mol
    lixisenatide 30 microg twice daily
    mean HbA1c reduction from baseline
    0.18%
    placebo
    mean HbA1c reduction from baseline
    2 mmol/mol
    placebo

    Source sentences

    Summary
    Lixisenatide significantly improved mean HbA(1c) from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 microg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo).
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, 68% receiving 20 and 30 microg once-daily lixisenatide reached HbA1c <7.0% (53 mmol/mol) versus 32% with placebo (P < 0.0001).

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

    Outcome
    IncreaseHbA1c target attainment
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20 and 30 microg once daily · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    patients reaching HbA1c <7.0% at study end
    68%
    lixisenatide 20 and 30 microg once daily
    patients reaching HbA1c <7.0% at study end
    32%
    placebo

    Source sentences

    Summary
    Target HbA(1c) < 7.0% (53 mmol/mol) at study end was achieved in 68% of patients receiving 20 and 30 microg once-daily lixisenatide vs. 32% receiving placebo (P < 0.0001).
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, lixisenatide showed dose-dependent improvements in fasting, postprandial and average self-monitored seven-point blood glucose.

    In plain wordsIn patients with diabetes, fasting, post-meal and average self-measured glucose improved with increasing lixisenatide doses.

    Outcome
    Direction not reportedFasting, postprandial and average seven-point blood glucose
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous · 13 weeksAs given in this study (human).

    Source sentences

    Summary
    Dose-dependent improvements were observed for fasting, postprandial and average self-monitored seven-point blood glucose levels.
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In metformin-treated patients with diabetes, weight changes ranged from -2.0 to -3.9 kg with lixisenatide versus -1.9 kg with placebo, so weight fell in all groups, including placebo.

    In plain wordsWeight fell by 2.0 to 3.9 kg with lixisenatide and by 1.9 kg with placebo.

    Outcome
    DecreaseWeight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    weight change
    −2 to −3.9 kg
    lixisenatide, range across doses
    weight change
    −1.9 kg
    placebo

    Source sentences

    Summary
    Weight changes ranged from -2.0 to -3.9 kg with lixisenatide vs. -1.9 kg with placebo.
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.
  12. 12HumanNon-randomized trialSafety outcome

    In a trial of lixisenatide doses in metformin-treated patients with diabetes, the most frequent adverse event reported was mild-to-moderate nausea.

    In plain wordsIn the lixisenatide trial, the most frequent adverse event reported was mild-to-moderate nausea.

    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 13 weeksAs given in this study (human).

    Source sentences

    Summary
    The most frequent adverse event was mild-to-moderate nausea.
    1 context sentence
    Summary · context
    Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA(1c)) > or = 7.0 and or = 53 and or = 1000 mg/day) treated with subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily or placebo.

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 2NCT00299871

Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

Sanofin = 542Feb 2006 to Aug 2007

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 28 Jan 2014

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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