Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1).

Bolli GB, Munteanu M, Dotsenko S, Niemoeller E, Boka G, Wu Y, Hanefeld M

Diabetic medicine : a journal of the British Diabetic Association24 Oct 2013Cited by 108 (Europe PMC)

PMID24117597DOI10.1111/dme.12328PepBankPUB-24117597

Publisher page PubMedAsk about this study

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 study14

14 results from studies that gave the peptide. 14 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on metformin, one-step lixisenatide significantly improved HbA1c versus placebo at week 24 (P < 0.0001).
In plain wordsIn patients with diabetes on metformin, one-step lixisenatide improved HbA1c more than placebo at week 24.
Peptide
Lixisenatide
Outcome
DecreaseHbA1c at week 24, one-step
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
One-step dose increase · 24 weeksAs given in this study (human).
Measurements
P
< 0.0001
one-step versus placebo
Source sentences
Summary
Lixisenatide one-/two-step once daily significantly improved HbA1c at week 24 compared with placebo (P < 0.0001) and allowed more participants to achieve HbA1c < 53 mmol/mol (< 7.0%) (P ≤ 0.0005).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759701
02HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on metformin, two-step lixisenatide significantly improved HbA1c versus placebo at week 24 (P < 0.0001).
In plain wordsIn patients with diabetes on metformin, two-step lixisenatide improved HbA1c more than placebo at week 24.
Peptide
Lixisenatide
Outcome
DecreaseHbA1c at week 24, two-step
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Two-step dose increase · 24 weeksAs given in this study (human).
Measurements
P
< 0.0001
two-step versus placebo
Source sentences
Summary
Lixisenatide one-/two-step once daily significantly improved HbA1c at week 24 compared with placebo (P < 0.0001) and allowed more participants to achieve HbA1c < 53 mmol/mol (< 7.0%) (P ≤ 0.0005).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759702
03HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on metformin, one-step lixisenatide increased HbA1c <7.0% attainment versus placebo (P ≤ 0.0005).
In plain wordsIn patients with diabetes on metformin, more patients reached HbA1c <7.0% with one-step lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c target attainment, one-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
One-step dose increase · 24 weeksAs given in this study (human).
Measurements
P
≤ 0.0005
one-step versus placebo
Source sentences
Summary
Lixisenatide one-/two-step once daily significantly improved HbA1c at week 24 compared with placebo (P < 0.0001) and allowed more participants to achieve HbA1c < 53 mmol/mol (< 7.0%) (P ≤ 0.0005).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759703
04HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on metformin, two-step lixisenatide increased HbA1c <7.0% attainment versus placebo (P ≤ 0.0005).
In plain wordsIn patients with diabetes on metformin, more patients reached HbA1c <7.0% with two-step lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c target attainment, two-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Two-step dose increase · 24 weeksAs given in this study (human).
Measurements
P
≤ 0.0005
two-step versus placebo
Source sentences
Summary
Lixisenatide one-/two-step once daily significantly improved HbA1c at week 24 compared with placebo (P < 0.0001) and allowed more participants to achieve HbA1c < 53 mmol/mol (< 7.0%) (P ≤ 0.0005).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759704
05HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on metformin, fasting glucose changed by -0.5 mmol/l with one-step lixisenatide versus +0.1 with placebo (P < 0.001).
In plain wordsIn patients with diabetes on metformin, one-step lixisenatide reduced fasting blood sugar more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseFasting plasma glucose, one-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
One-step dose increase · 24 weeksAs given in this study (human).
Measurements
Change
−0.5 mmol/l
one-step lixisenatide
Change
0.1 mmol/l
placebo
P
< 0.001
versus placebo
Source sentences
Summary
Improvements were observed in fasting plasma glucose (-0.5/-0.6 vs. +0.1 mmol/l; P < 0.001) and body weight (-2.6/-2.7 vs. -1.6 kg; P < 0.005).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759705
06HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on metformin, fasting glucose changed by -0.6 mmol/l with two-step lixisenatide versus +0.1 with placebo (P < 0.001).
In plain wordsIn patients with diabetes on metformin, two-step lixisenatide reduced fasting blood sugar more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseFasting plasma glucose, two-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Two-step dose increase · 24 weeksAs given in this study (human).
Measurements
Change
−0.6 mmol/l
two-step lixisenatide
Change
0.1 mmol/l
placebo
P
< 0.001
versus placebo
Source sentences
Summary
Improvements were observed in fasting plasma glucose (-0.5/-0.6 vs. +0.1 mmol/l; P < 0.001) and body weight (-2.6/-2.7 vs. -1.6 kg; P < 0.005).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759706
07HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on metformin, weight changed by -2.6 kg with one-step lixisenatide versus -1.6 kg with placebo (P < 0.005).
In plain wordsIn patients with diabetes on metformin, one-step lixisenatide reduced weight more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseBody weight, one-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
One-step dose increase · 24 weeksAs given in this study (human).
Measurements
Change
−2.6 kg
one-step lixisenatide
Change
−1.6 kg
placebo
P
< 0.005
versus placebo
Source sentences
Summary
Improvements were observed in fasting plasma glucose (-0.5/-0.6 vs. +0.1 mmol/l; P < 0.001) and body weight (-2.6/-2.7 vs. -1.6 kg; P < 0.005).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759707
08HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on metformin, weight changed by -2.7 kg with two-step lixisenatide versus -1.6 kg with placebo (P < 0.005).
In plain wordsIn patients with diabetes on metformin, two-step lixisenatide reduced weight more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseBody weight, two-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
Two-step dose increase · 24 weeksAs given in this study (human).
Measurements
Change
−2.7 kg
two-step lixisenatide
Change
−1.6 kg
placebo
P
< 0.005
versus placebo
Source sentences
Summary
Improvements were observed in fasting plasma glucose (-0.5/-0.6 vs. +0.1 mmol/l; P < 0.001) and body weight (-2.6/-2.7 vs. -1.6 kg; P < 0.005).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759708
09HumanRandomized controlled trialSafety outcome
In patients with diabetes on metformin, adverse events occurred in 67.7% with one-step lixisenatide versus 65.6% with placebo at week 24.
In plain wordsIn patients with diabetes on metformin, side effects occurred more often with one-step lixisenatide than placebo at week 24.
Peptide
Lixisenatide
Outcome
IncreaseAdverse events, one-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
One-step dose increase · 24 weeksAs given in this study (human).
Measurements
Incidence
67.7%
one-step lixisenatide
Incidence
65.6%
placebo
Source sentences
Summary
At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one-/two-step/placebo, respectively--nausea and vomiting being reported most frequently.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759709
10HumanRandomized controlled trialSafety outcome
In patients with diabetes on metformin, adverse events occurred in 70.8% with two-step lixisenatide versus 65.6% with placebo at week 24.
In plain wordsIn patients with diabetes on metformin, side effects occurred more often with two-step lixisenatide than placebo at week 24.
Peptide
Lixisenatide
Outcome
IncreaseAdverse events, two-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
Two-step dose increase · 24 weeksAs given in this study (human).
Measurements
Incidence
70.8%
two-step lixisenatide
Incidence
65.6%
placebo
Source sentences
Summary
At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one-/two-step/placebo, respectively--nausea and vomiting being reported most frequently.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759710
11HumanRandomized controlled trialSafety outcome
In patients with diabetes on metformin, symptomatic hypoglycemia occurred in 1.9% with one-step lixisenatide versus 0.6% with placebo.
In plain wordsIn patients with diabetes on metformin, low blood sugar symptoms were more frequent with one-step lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseSymptomatic hypoglycemia, one-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
One-step dose increase · 24 weeksAs given in this study (human).
Measurements
Incidence
1.9%
one-step lixisenatide
Incidence
0.6%
placebo
Source sentences
Summary
Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one-/two-step lixisenatide and 0.6% with placebo, with no severe episodes.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759713
12HumanRandomized controlled trialSafety outcome
In patients with diabetes on metformin, symptomatic hypoglycemia occurred in 2.5% with two-step lixisenatide versus 0.6% with placebo.
In plain wordsIn patients with diabetes on metformin, low blood sugar symptoms were more frequent with two-step lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseSymptomatic hypoglycemia, two-step
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
Two-step dose increase · 24 weeksAs given in this study (human).
Measurements
Incidence
2.5%
two-step lixisenatide
Incidence
0.6%
placebo
Source sentences
Summary
Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one-/two-step lixisenatide and 0.6% with placebo, with no severe episodes.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759714
13HumanRandomized controlled trialSafety outcome
In patients with diabetes on metformin, no severe hypoglycemia episodes occurred with lixisenatide or placebo.
In plain wordsIn patients with diabetes on metformin, neither lixisenatide nor placebo patients had severe low blood sugar episodes.
Peptide
Lixisenatide
Outcome
No significant changeSevere hypoglycemia
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
Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one-/two-step lixisenatide and 0.6% with placebo, with no severe episodes.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759715
14HumanNon-randomized trialSafety outcome
In patients with diabetes on metformin, nausea and vomiting were the adverse events reported most frequently in the lixisenatide versus placebo trial; the abstract gives no per-arm rates for them.
In plain wordsIn patients with diabetes on metformin, nausea and vomiting were the side effects reported most often in the lixisenatide trial.
Peptide
Lixisenatide
Outcome
Direction not reportedNausea and vomiting frequency
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 24 weeksAs given in this study (human).
Source sentences
Summary
At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one-/two-step/placebo, respectively--nausea and vomiting being reported most frequently.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin.
Summary · context
Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period.
Report a problemFND-2411759711

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 postedNCT00763451

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

Sanofin = 484Sept 2008 to Jan 2011

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 14 Dec 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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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