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Study · Randomized controlled trial · 2016

6 results

Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.

Rosenstock J, Guerci B, Hanefeld M, Gentile S, Aronson R, Tinahones FJ, Roy-Duval C, Souhami E, Wardecki M, Ye J, Perfetti R, Heller S

Diabetes care23 May 2016Cited by 105 (Europe PMC)

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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes, lixisenatide met HbA1c noninferiority versus once-daily glulisine, with both reaching 7.2% at 26 weeks.

    In plain wordsIn patients with diabetes, lixisenatide met the HbA1c noninferiority criterion compared with once-daily glulisine.

    Outcome
    Direction not reportedHbA1c versus once-daily glulisine
    Study

    n: not reported in source

    Comparator
    Insulin glulisine once daily
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    HbA1c at coprimary endpoint
    7.2%
    lixisenatide
    HbA1c at coprimary endpoint
    55 mmol/mol
    lixisenatide
    HbA1c at coprimary endpoint
    7.2%
    glulisine once daily
    HbA1c at coprimary endpoint
    55 mmol/mol
    glulisine once daily

    Source sentences

    Summary
    HbA1c improved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with lixisenatide and glulisine once daily and thrice daily, respectively; all coprimary end points were met.
    2 context sentences
    Summary · context
    Coprimary end points at 26 weeks were 1) noninferiority (95% CI upper bound <0.4% [<4.4 mmol/mol]) in HbA1c reduction with lixisenatide versus glulisine once daily, and either 2a) noninferiority in HbA1c reduction for lixisenatide versus glulisine thrice daily or 2b) superiority in body weight chang…
    Summary · context
    Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes, HbA1c reached 7.2% with lixisenatide versus 7.0% with thrice-daily glulisine at 26 weeks; coprimary criteria were met.

    In plain wordsIn patients with diabetes, HbA1c was numerically higher with lixisenatide than thrice-daily glulisine; the trial met its coprimary criteria.

    Outcome
    IncreaseHbA1c versus thrice-daily glulisine
    Study

    n: not reported in source

    Comparator
    Insulin glulisine thrice daily
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    HbA1c at coprimary endpoint
    7.2%
    lixisenatide
    HbA1c at coprimary endpoint
    55 mmol/mol
    lixisenatide
    HbA1c at coprimary endpoint
    7%
    glulisine thrice daily
    HbA1c at coprimary endpoint
    53 mmol/mol
    glulisine thrice daily

    Source sentences

    Summary
    HbA1c improved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with lixisenatide and glulisine once daily and thrice daily, respectively; all coprimary end points were met.
    2 context sentences
    Summary · context
    Coprimary end points at 26 weeks were 1) noninferiority (95% CI upper bound <0.4% [<4.4 mmol/mol]) in HbA1c reduction with lixisenatide versus glulisine once daily, and either 2a) noninferiority in HbA1c reduction for lixisenatide versus glulisine thrice daily or 2b) superiority in body weight chang…
    Summary · context
    Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization.
  3. 03HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes, symptomatic hypoglycemia was lower with lixisenatide than glulisine.

    In plain wordsIn patients with diabetes, symptomatic hypoglycemia was lower with lixisenatide than glulisine.

    Outcome
    DecreaseSymptomatic hypoglycemia
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Symptomatic hypoglycemia and body weight were lower in lixisenatide versus glulisine patients.
    1 context sentence
    Summary · context
    Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes, body weight was lower with lixisenatide than glulisine.

    In plain wordsIn patients with diabetes, body weight was lower with lixisenatide than glulisine.

    Outcome
    DecreaseBody weight
    Study

    n: not reported in source

    Comparator
    Insulin glulisine
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Symptomatic hypoglycemia and body weight were lower in lixisenatide versus glulisine patients.
    1 context sentence
    Summary · context
    Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization.
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes, more gastrointestinal events occurred with lixisenatide than glulisine.

    In plain wordsIn patients with diabetes, gastrointestinal events were more frequent with lixisenatide than glulisine.

    Outcome
    IncreaseGastrointestinal events
    Study

    n: not reported in source

    Comparator
    Insulin glulisine
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    More gastrointestinal events occurred with lixisenatide.
    1 context sentence
    Summary · context
    Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization.
  6. 06HumanNon-randomized trialEfficacy outcome

    In patients with type 2 diabetes, HbA1c decreased from 7.9% after glargine optimization to 7.2% with lixisenatide.

    In plain wordsIn patients with diabetes, HbA1c decreased from the optimized-glargine baseline during lixisenatide treatment.

    Outcome
    DecreaseWithin-arm HbA1c
    Study

    n: not reported in source

    Comparator
    Baseline after glargine optimization
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    HbA1c after glargine optimization (baseline)
    7.9%
    before lixisenatide add-on
    HbA1c after glargine optimization (baseline)
    63 mmol/mol
    before lixisenatide add-on
    HbA1c with lixisenatide
    7.2%
    lixisenatide add-on arm
    HbA1c with lixisenatide
    55 mmol/mol
    lixisenatide add-on arm

    Source sentences

    Summary
    HbA1c improved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with lixisenatide and glulisine once daily and thrice daily, respectively; all coprimary end points were met.
    1 context sentence
    Summary · context
    Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization.

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 postedNCT01768559

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

Sanofin = 894Jan 2013 to Dec 2014

Type 2 Diabetes

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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