Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1).

Riddle MC, Forst T, Aronson R, Sauque-Reyna L, Souhami E, Silvestre L, Ping L, Rosenstock J

Diabetes care5 Apr 2013Cited by 217 (Europe PMC)

PMID23564915PMCIDPMC3747901DOI10.2337/dc12-2462PepBankPUB-23564915

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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-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on insulin glargine, HbA1c fell 0.71% with lixisenatide versus 0.40% with placebo (difference -0.32%, 95% CI -0.46 to -0.17).
In plain wordsIn patients with diabetes on basal insulin, lixisenatide lowered HbA1c more than placebo.
Peptide
Lixisenatide
Outcome
DecreaseHbA1c
Study
n = 446
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg · 24 weeksAs given in this study (human).
Measurements
HbA1c reduction after randomization
0.71%
lixisenatide
HbA1c reduction after randomization
0.4%
placebo
LS mean difference
−0.32%
lixisenatide vs placebo
95% CI of LS mean difference
−0.46 to −0.17%
lixisenatide vs placebo
P value
< 0.0001 P
lixisenatide vs placebo
Source sentences
Summary
HbA1c had decreased during run-in from 8.6 to 7.6%; adding lixisenatide further reduced HbA1c by 0.71 vs. 0.40% with placebo (least squares mean difference, -0.32%; 95% CI, -0.46 to -0.17; P < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary end point was HbA1c change after randomization.
Summary · context
Insulin glargine was added and systematically titrated during a 12-week run-in, after which candidates with fasting glucose ≤ 7.8 mmol/L and HbA1c 7-9% were randomized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued.
Report a problemFND-2356491501
02HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on insulin glargine, 56% attained HbA1c <7% with lixisenatide versus 39% with placebo (P < 0.0001).
In plain wordsIn patients with diabetes on basal insulin, more patients reached the HbA1c target with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c below 7%
Study
n = 446
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg · 24 weeksAs given in this study (human).
Measurements
HbA1c <7% attained
56%
lixisenatide
HbA1c <7% attained
39%
placebo
P value
< 0.0001 P
lixisenatide vs placebo
Source sentences
Summary
More participants attained HbA1c <7% with lixisenatide (56 vs. 39%; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Insulin glargine was added and systematically titrated during a 12-week run-in, after which candidates with fasting glucose ≤ 7.8 mmol/L and HbA1c 7-9% were randomized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued.
Report a problemFND-2356491502
03HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on insulin glargine, lixisenatide reduced post-breakfast glucose versus placebo by 3.2 mmol/L (P < 0.0001).
In plain wordsIn patients with diabetes on basal insulin, lixisenatide lowered glucose after breakfast more than placebo.
Peptide
Lixisenatide
Outcome
DecreasePostprandial glucose
Study
n = 446
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
20 µg · 24 weeksAs given in this study (human).
Measurements
2-h post-breakfast plasma glucose difference vs placebo
−3.2 mmol/L
lixisenatide vs placebo
P value
< 0.0001 P
lixisenatide vs placebo
Source sentences
Summary
Lixisenatide reduced plasma glucose 2 h after a standardized breakfast (difference vs. placebo -3.2 mmol/L; P < 0.0001) and had a favorable effect on body weight (difference vs. placebo -0.89 kg; P = 0.0012).
1 context sentence(design, population, supporting numbers)
Summary · context
Insulin glargine was added and systematically titrated during a 12-week run-in, after which candidates with fasting glucose ≤ 7.8 mmol/L and HbA1c 7-9% were randomized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued.
Report a problemFND-2356491503
04HumanRandomized controlled trialEfficacy outcome
In patients with diabetes on insulin glargine, lixisenatide reduced weight versus placebo by 0.89 kg (P = 0.0012).
In plain wordsIn patients with diabetes on basal insulin, lixisenatide reduced weight compared with placebo.
Peptide
Lixisenatide
Outcome
DecreaseBody weight
Study
n = 446
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
20 µg · 24 weeksAs given in this study (human).
Measurements
Body weight difference vs placebo
−0.89 kg
lixisenatide vs placebo
P value
0.0012 P
lixisenatide vs placebo
Source sentences
Summary
Lixisenatide reduced plasma glucose 2 h after a standardized breakfast (difference vs. placebo -3.2 mmol/L; P < 0.0001) and had a favorable effect on body weight (difference vs. placebo -0.89 kg; P = 0.0012).
1 context sentence(design, population, supporting numbers)
Summary · context
Insulin glargine was added and systematically titrated during a 12-week run-in, after which candidates with fasting glucose ≤ 7.8 mmol/L and HbA1c 7-9% were randomized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued.
Report a problemFND-2356491504
05HumanRandomized controlled trialSafety outcome
In patients with diabetes on insulin glargine, nausea was more common with lixisenatide than placebo.
In plain wordsIn patients with diabetes on basal insulin, nausea was more common with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseNausea
Study
n = 446
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
20 µg · 24 weeksAs given in this study (human).
Source sentences
Summary
Nausea, vomiting, and symptomatic hypoglycemia <3.3 mmol/L were more common with lixisenatide.
1 context sentence(design, population, supporting numbers)
Summary · context
Insulin glargine was added and systematically titrated during a 12-week run-in, after which candidates with fasting glucose ≤ 7.8 mmol/L and HbA1c 7-9% were randomized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued.
Report a problemFND-2356491505
06HumanRandomized controlled trialSafety outcome
In patients with diabetes on insulin glargine, vomiting was more common with lixisenatide than placebo.
In plain wordsIn patients with diabetes on basal insulin, vomiting was more common with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseVomiting
Study
n = 446
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
20 µg · 24 weeksAs given in this study (human).
Source sentences
Summary
Nausea, vomiting, and symptomatic hypoglycemia <3.3 mmol/L were more common with lixisenatide.
1 context sentence(design, population, supporting numbers)
Summary · context
Insulin glargine was added and systematically titrated during a 12-week run-in, after which candidates with fasting glucose ≤ 7.8 mmol/L and HbA1c 7-9% were randomized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued.
Report a problemFND-2356491506
07HumanRandomized controlled trialSafety outcome
In patients with diabetes on insulin glargine, symptomatic hypoglycemia <3.3 mmol/L was more common with lixisenatide than placebo.
In plain wordsIn patients with diabetes on basal insulin, symptomatic low glucose was more common with lixisenatide than placebo.
Peptide
Lixisenatide
Outcome
IncreaseSymptomatic hypoglycemia
Study
n = 446
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 µg · 24 weeksAs given in this study (human).
Source sentences
Summary
Nausea, vomiting, and symptomatic hypoglycemia <3.3 mmol/L were more common with lixisenatide.
1 context sentence(design, population, supporting numbers)
Summary · context
Insulin glargine was added and systematically titrated during a 12-week run-in, after which candidates with fasting glucose ≤ 7.8 mmol/L and HbA1c 7-9% were randomized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued.
Report a problemFND-2356491507

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 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 page ClinicalTrials.govUpdated 11 Oct 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

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