Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial.

Rosenstock J, Diamant M, Aroda VR, Silvestre L, Souhami E, Zhou T, Perfetti R, Fonseca V

Diabetes care9 Jun 2016Cited by 62 (Europe PMC)

PMID27284114PMCIDPMC5001145DOI10.2337/dc16-0046PepBankPUB-27284114

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 study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In insulin-naïve patients with type 2 diabetes, LixiLan reduced HbA1c from 8.0% to 6.3% versus 6.5% with glargine, meeting noninferiority and superiority criteria (difference -0.17%, 95% CI -0.31 to -0.04; P = 0.01).
In plain wordsIn insulin-naïve patients with diabetes, LixiLan reduced HbA1c more than insulin glargine.
Peptide
Lixisenatide
Outcome
DecreaseHbA1c at week 24
Study
n = 323
Comparator
Insulin glargine
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Fixed-ratio LixiLan, 2 units insulin glargine to 1 µg lixisenatide once daily; started at 10 units/5 µg and titrated to fasting plasma glucose · 24 weeksAs given in this study (human).
Measurements
HbA1c at week 24
8%
baseline
HbA1c at week 24
6.3%
LixiLan
HbA1c at week 24
6.5%
Gla-100
HbA1c difference LixiLan minus Gla-100
−0.17%
least-squared mean difference
95% CI of HbA1c difference
−0.31 to −0.04%
LixiLan minus Gla-100
Source sentences
Summary
At week 24, mean HbA1c was reduced from 8.0% (64 mmol/mol) at baseline to 6.3% (45 mmol/mol) and 6.5% (48 mmol/mol) with LixiLan and Gla-100, respectively, establishing statistical noninferiority and superiority of LixiLan (least-squared mean [95% CI] difference: -0.17% [-0.31, -0.04] {-1.9 mmol/mol…
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were randomized to once-daily LixiLan (n = 161) or Gla-100 (n = 162) for 24 weeks, while continuing metformin.
Summary · context
LixiLan and Gla-100 were started at 10 units/5 μg and 10 units, respectively, and titrated based on the Gla-100 requirement according to fasting plasma glucose levels.
Report a problemFND-2728411401
02HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, weight decreased with LixiLan (-1 kg) versus an increase with glargine (+0.5 kg; P < 0.0001).
In plain wordsIn patients with diabetes, weight decreased with LixiLan and increased with insulin glargine.
Peptide
Lixisenatide
Outcome
DecreaseBody weight
Study
n = 323
Comparator
Insulin glargine
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
Fixed-ratio LixiLan, 2 units insulin glargine to 1 µg lixisenatide once daily; started at 10 units/5 µg and titrated to fasting plasma glucose · 24 weeksAs given in this study (human).
Measurements
Body weight change
−1 kg
LixiLan
Body weight change
0.5 kg
Gla-100
Source sentences
Summary
Body weight was reduced with LixiLan (-1 kg) and increased with Gla-100 (+0.5 kg; P < 0.0001), with no increase in hypoglycemic events (∼25% in each group).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were randomized to once-daily LixiLan (n = 161) or Gla-100 (n = 162) for 24 weeks, while continuing metformin.
Summary · context
LixiLan and Gla-100 were started at 10 units/5 μg and 10 units, respectively, and titrated based on the Gla-100 requirement according to fasting plasma glucose levels.
Report a problemFND-2728411404
03HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, hypoglycemic events did not increase with LixiLan versus glargine, occurring in ∼25% in each group.
In plain wordsIn patients with diabetes, hypoglycemic events did not increase with LixiLan compared with insulin glargine.
Peptide
Lixisenatide
Outcome
Direction not reportedHypoglycemic events
Study
n = 323
Comparator
Insulin glargine
Analysis
Secondary
Outcome group
Adverse events · Metabolic and weight
Studied dose
Fixed-ratio LixiLan, 2 units insulin glargine to 1 µg lixisenatide once daily; started at 10 units/5 µg and titrated to fasting plasma glucose · 24 weeksAs given in this study (human).
Measurements
Hypoglycemic events
≈ 25%
LixiLan
Hypoglycemic events
≈ 25%
Gla-100
Source sentences
Summary
Body weight was reduced with LixiLan (-1 kg) and increased with Gla-100 (+0.5 kg; P < 0.0001), with no increase in hypoglycemic events (∼25% in each group).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were randomized to once-daily LixiLan (n = 161) or Gla-100 (n = 162) for 24 weeks, while continuing metformin.
Summary · context
LixiLan and Gla-100 were started at 10 units/5 μg and 10 units, respectively, and titrated based on the Gla-100 requirement according to fasting plasma glucose levels.
Report a problemFND-2728411405
04HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, HbA1c <7.0% occurred in 84% with LixiLan versus 78% with glargine; the difference was nonsignificant.
In plain wordsIn patients with diabetes, more LixiLan patients reached the HbA1c target than glargine patients, but the difference was nonsignificant.
Peptide
Lixisenatide
Outcome
IncreaseHbA1c target below 7.0%
Study
n = 323
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Fixed-ratio LixiLan, 2 units insulin glargine to 1 µg lixisenatide once daily; started at 10 units/5 µg and titrated to fasting plasma glucose · 24 weeksAs given in this study (human).
Measurements
HbA1c below 7.0% achieved
84%
LixiLan
HbA1c below 7.0% achieved
78%
Gla-100
Source sentences
Summary
HbA1c <7.0% (<53 mmol/mol) was achieved in 84% and 78% of participants (nonsignificant), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were randomized to once-daily LixiLan (n = 161) or Gla-100 (n = 162) for 24 weeks, while continuing metformin.
Summary · context
LixiLan and Gla-100 were started at 10 units/5 μg and 10 units, respectively, and titrated based on the Gla-100 requirement according to fasting plasma glucose levels.
Report a problemFND-2728411402
05HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, LixiLan reduced 2-h postmeal glucose versus glargine by -3.17 mmol/L [-57 mg/dL] (P < 0.0001).
In plain wordsIn patients with diabetes, LixiLan reduced postmeal glucose compared with insulin glargine.
Peptide
Lixisenatide
Outcome
DecreasePostmeal plasma glucose
Study
n = 323
Comparator
Insulin glargine
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Fixed-ratio LixiLan, 2 units insulin glargine to 1 µg lixisenatide once daily; started at 10 units/5 µg and titrated to fasting plasma glucose · 24 weeksAs given in this study (human).
Measurements
2-h postmeal plasma glucose difference
−3.17 mmol/L
LixiLan minus Gla-100, least-squared mean
2-h postmeal plasma glucose difference
−57 mg/dL
LixiLan minus Gla-100, least-squared mean
Source sentences
Summary
LixiLan improved 2-h postmeal plasma glucose versus Gla-100 (least-squared mean difference: -3.17 mmol/L [-57 mg/dL]; P < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were randomized to once-daily LixiLan (n = 161) or Gla-100 (n = 162) for 24 weeks, while continuing metformin.
Summary · context
LixiLan and Gla-100 were started at 10 units/5 μg and 10 units, respectively, and titrated based on the Gla-100 requirement according to fasting plasma glucose levels.
Report a problemFND-2728411403

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 2Results postedNCT01476475

Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Sanofin = 323Nov 2011 to Dec 2012

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 10 Feb 2017

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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