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Study · Randomized controlled trial · n = 448 · 2018

8 results

Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial.

Yang W, Min K, Zhou Z, Li L, Xu X, Zhu D, Venkateshwar Rao A, Murthy LS, Zhang N, Li I, Niemoeller E, Shang S

Diabetes, obesity & metabolism5 Oct 2017Cited by 32 (Europe PMC)

PMID28742225 (opens in a new tab)PMCIDPMC5813270 (opens in a new tab)DOI10.1111/dom.13072 (opens in a new tab)PepBankPUB-28742225
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, HbA1c changed -0.62% with lixisenatide versus -0.11% with placebo (P < .0001).

    In plain wordsIn patients with diabetes on basal insulin, lixisenatide reduced HbA1c more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseHbA1c change at week 24
    Study

    n = 448

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

    Measurements

    HbA1c LS mean change from baseline
    −0.62%
    lixisenatide, week 24
    Standard error of LS mean change
    0.09%
    lixisenatide, week 24
    HbA1c LS mean change from baseline
    −0.11%
    placebo, week 24
    Standard error of LS mean change
    0.09%
    placebo, week 24
    P value
    < 0.0001
    lixisenatide versus placebo

    Source sentences

    Summary
    After insulin optimization during run-in, lixisenatide was superior to placebo in mean change from baseline (7.9% [standard deviation {s.d.}, 0.66] and 7.9% [0.70], respectively) to week 24 in HbA1c (least squares mean [standard error {s.e.}] change -0.62% [0.09] vs -0.11% [0.09]; P < .0001, respect…
    1 context sentence
    Summary · context
    Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, more patients achieved HbA1c targets with lixisenatide than placebo.

    In plain wordsIn patients with diabetes on basal insulin, more patients reached HbA1c targets with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseHbA1c target attainment
    Study

    n = 448

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

    Source sentences

    Summary
    and higher proportions of patients achieved HbA1c targets.
    1 context sentence
    Summary · context
    Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, lixisenatide reduced 2-hour postprandial glucose more than placebo.

    In plain wordsIn patients with diabetes on basal insulin, lixisenatide reduced glucose after meals more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreasePostprandial plasma glucose
    Study

    n = 448

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

    Source sentences

    Summary
    Two-hour PPG, daily mean SMPG and mean BW were reduced further and daily BI dose was lower with lixisenatide than placebo (-1.12 kg vs 0.04 kg [P < .0001]; -3.0 U vs -1.9 U [P = .0033], respectively).
    1 context sentence
    Summary · context
    Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, lixisenatide reduced daily mean self-monitored plasma glucose more than placebo.

    In plain wordsIn patients with diabetes on basal insulin, lixisenatide reduced daily average glucose more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseDaily mean self-monitored plasma glucose
    Study

    n = 448

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

    Source sentences

    Summary
    Two-hour PPG, daily mean SMPG and mean BW were reduced further and daily BI dose was lower with lixisenatide than placebo (-1.12 kg vs 0.04 kg [P < .0001]; -3.0 U vs -1.9 U [P = .0033], respectively).
    1 context sentence
    Summary · context
    Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes on basal insulin, weight changed -1.12 kg with lixisenatide versus 0.04 kg with placebo (P < .0001).

    In plain wordsIn patients with diabetes on basal insulin, lixisenatide reduced body weight more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseBody weight
    Study

    n = 448

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

    Measurements

    Body weight change
    −1.12 kg
    lixisenatide, week 24
    Body weight change
    0.04 kg
    placebo, week 24
    P value
    < 0.0001
    lixisenatide versus placebo

    Source sentences

    Summary
    Two-hour PPG, daily mean SMPG and mean BW were reduced further and daily BI dose was lower with lixisenatide than placebo (-1.12 kg vs 0.04 kg [P < .0001]; -3.0 U vs -1.9 U [P = .0033], respectively).
    1 context sentence
    Summary · context
    Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In patients with diabetes, basal insulin dose changed -3.0 U with lixisenatide versus -1.9 U with placebo (P = .0033).

    In plain wordsIn patients with diabetes, lixisenatide reduced daily basal insulin dose more than placebo.

    Peptide
    Lixisenatide
    Outcome
    DecreaseDaily basal insulin dose
    Study

    n = 448

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Patterns of use · Metabolic and weight
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    Change in daily basal insulin dose
    −3 U
    lixisenatide, week 24
    Change in daily basal insulin dose
    −1.9 U
    placebo, week 24
    P value
    0.0033
    lixisenatide versus placebo

    Source sentences

    Summary
    Two-hour PPG, daily mean SMPG and mean BW were reduced further and daily BI dose was lower with lixisenatide than placebo (-1.12 kg vs 0.04 kg [P < .0001]; -3.0 U vs -1.9 U [P = .0033], respectively).
    1 context sentence
    Summary · context
    Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L).
  7. 07HumanRandomized controlled trialSafety outcome

    In patients with diabetes on basal insulin, treatment-emergent adverse events occurred in 63.8% with lixisenatide versus 40.8% with placebo.

    In plain wordsIn patients with diabetes on basal insulin, adverse events were more frequent with lixisenatide than placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseTreatment-emergent adverse events
    Study

    n = 448

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 24 weeksAs given in this study (human).

    Measurements

    Treatment-emergent adverse events
    63.8%
    lixisenatide
    Treatment-emergent adverse events
    40.8%
    placebo

    Source sentences

    Summary
    Treatment-emergent adverse events were greater with lixisenatide than placebo (63.8% vs 40.8%, respectively).
    1 context sentence
    Summary · context
    Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L).
  8. 08HumanRandomized controlled trialSafety outcome

    In patients with diabetes on basal insulin, symptomatic hypoglycemia incidence was similar with lixisenatide (15.6%) and placebo (13.5%).

    In plain wordsIn patients with diabetes on basal insulin, symptomatic low blood sugar occurred at similar rates with lixisenatide and placebo.

    Peptide
    Lixisenatide
    Outcome
    IncreaseSymptomatic hypoglycemia
    Study

    n = 448

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

    Measurements

    Incidence of symptomatic hypoglycaemia
    15.6%
    lixisenatide
    Incidence of symptomatic hypoglycaemia
    13.5%
    placebo

    Source sentences

    Summary
    The incidence of symptomatic hypoglycaemia was similar (lixisenatide 15.6% vs placebo 13.5%).
    1 context sentence
    Summary · context
    Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L).

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 3NCT01632163

Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Sanofin = 447Oct 2012 to May 2015

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 15 Jun 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

    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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