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Study · Randomized controlled trial · n = 1,071 · 2020

2 results

Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data.

Davidson JA, Stager W, Paranjape S, Berria R, Leiter LA

Clinical diabetes and endocrinology14 Jan 2020Cited by 5 (Europe PMC)

Summary

BackgroundTo examine the impact on glycemic control of achieving postprandial glucose (PPG) target with lixisenatide, a once-daily glucagon-like peptide-1 receptor agonist approved in the US, in patients with uncontrolled type 2 diabetes (T2D) on basal insulin, an agent that primarily targets fasting plasma glucose.MethodsA post hoc pooled analysis was conducted using clinical trial data extracted from the intent-to-treat subpopulation of patients with T2D who participated in the 24-week, phase 3, randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter GetGoal-L (NCT00715624), GetGoal-Duo 1 (NCT00975286) and GetGoal-L Asia trials (NCT00866658).ResultsData from 587 lixisenatide-treated patients and 484 placebo-treated patients were included. Patients on lixisenatide were more likely to achieve a PPG target of < 10 mmol/L (< 180 mg/dL) than placebo-treated patients (P < 0.001), regardless of baseline fasting plasma glucose (FPG) levels. More importantly, those who reached the PPG target experienced a significantly greater reduction in mean HbA1c, were more likely to achieve HbA1c target of < 53 mmol/mol (< 7.0%), and experienced weight loss. Those outcomes were achieved with no significant differences in the risk of symptomatic hypoglycemia compared with placebo.ConclusionCompared with placebo, addition of lixisenatide to basal insulin improved HbA1c and reduced PPG, without increasing hypoglycemia risk. These findings highlight the importance of PPG control in the management of T2D, and provide evidence that adding an agent to basal insulin therapy that also impacts PPG has therapeutic value for patients who are not meeting glycemic targets.Trial registrationNCT00715624. Registered 15 July 2008, NCT00975286. Registered 11 September 2009, NCT00866658. Registered 20 March 2009.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes on basal insulin, lixisenatide increased attainment of PPG below 10 mmol/L versus placebo (P < 0.001).

    In plain wordsIn patients with type 2 diabetes on basal insulin, lixisenatide increased post-meal glucose target attainment versus placebo.

    Outcome
    IncreasePPG target attainment
    Study

    n = 1,071

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    P value
    < 0.001
    lixisenatide vs placebo, PPG <10 mmol/L

    Source sentences

    Summary
    Patients on lixisenatide were more likely to achieve a PPG target of < 10 mmol/L (< 180 mg/dL) than placebo-treated patients (P < 0.001), regardless of baseline fasting plasma glucose (FPG) levels.
    1 context sentence
    Summary · context
    Data from 587 lixisenatide-treated patients and 484 placebo-treated patients were included.
  2. 02HumanObservational studySafety outcome

    Lixisenatide-treated PPG target achievers had no significant difference in symptomatic hypoglycemia risk versus placebo.

    In plain wordsLixisenatide-treated patients reaching the post-meal glucose target had no significant difference in symptomatic low blood sugar risk versus placebo.

    Outcome
    No significant changeSymptomatic hypoglycemia risk
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Those outcomes were achieved with no significant differences in the risk of symptomatic hypoglycemia compared with placebo.
    2 context sentences
    Summary · context
    More importantly, those who reached the PPG target experienced a significantly greater reduction in mean HbA1c, were more likely to achieve HbA1c target of < 53 mmol/mol (< 7.0%), and experienced weight loss.
    Summary · context
    Data from 587 lixisenatide-treated patients and 484 placebo-treated patients were included.

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 · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00975286

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

Sanofin = 446Oct 2009 to Aug 2011

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 11 Oct 2016
CompletedPhase 3Results postedNCT00866658

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea (GETGOAL-L-ASIA)

Sanofin = 311Mar 2009 to Jun 2010

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 11 Oct 2016
CompletedPhase 3Results postedNCT00715624

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin

Sanofin = 496Jul 2008 to Feb 2011

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 28 Nov 2016

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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