Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial.

Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simó R

Diabetologia14 Aug 2009Cited by 614 (Europe PMC)

PMID19688338PMCIDPMC2744824DOI10.1007/s00125-009-1472-yPepBankPUB-19688338

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 study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin and glimepiride, liraglutide reduced HbA1c by 1.33% versus 1.09% with insulin glargine, a difference of -0.24%.
In plain wordsIn adults with type 2 diabetes, liraglutide lowered HbA1c slightly more than insulin glargine did.
Peptide
Liraglutide
Outcome
DecreaseHbA1c reduction
Study
n = 462
Comparator
Insulin glargine
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
HbA1c reduction
1.33%
liraglutide
HbA1c reduction
1.09%
insulin glargine
HbA1c difference
−0.24%
liraglutide vs glargine
Source sentences
Summary
Liraglutide reduced HbA(1c) significantly vs glargine (1.33% vs 1.09%; -0.24% difference, 95% CI 0.08, 0.39; p = 0.0015)
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833801
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin and glimepiride, liraglutide reduced HbA1c significantly more than placebo (difference -1.09%).
In plain wordsIn adults with type 2 diabetes, liraglutide lowered HbA1c more than placebo did.
Peptide
Liraglutide
Outcome
DecreaseHbA1c reduction
Study
n = 344
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
HbA1c difference
−1.09%
liraglutide vs placebo
Source sentences
Summary
and placebo (-1.09% difference, 95% CI 0.90, 1.28; p < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833802
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin and glimepiride, liraglutide gave greater weight loss than insulin glargine (treatment difference -3.43 kg).
In plain wordsIn adults with type 2 diabetes, people lost more weight with liraglutide than with insulin glargine.
Peptide
Liraglutide
Outcome
DecreaseBody weight
Study
n = 462
Comparator
Insulin glargine
Outcome group
Body weight · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
body weight treatment difference
−3.43 kg
liraglutide vs glargine
Source sentences
Summary
and vs glargine (treatment difference -3.43 kg, 95% CI 4.00, 2.86; p < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833804
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin and glimepiride, liraglutide reduced systolic blood pressure by 4.0 mmHg versus a rise of 0.5 mmHg with insulin glargine.
In plain wordsIn adults with type 2 diabetes, liraglutide lowered systolic blood pressure while it rose slightly with insulin glargine.
Peptide
Liraglutide
Outcome
DecreaseSystolic blood pressure
Study
n = 462
Comparator
Insulin glargine
Outcome group
Blood pressure · Cardiovascular
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
systolic BP change
−4 mmHg
liraglutide
systolic BP change
0.5 mmHg
insulin glargine
systolic BP difference
−4.5 mmHg
liraglutide vs glargine
Source sentences
Summary
Liraglutide reduced systolic BP (-4.0 mmHg) vs glargine (+0.5 mmHg; -4.5 mmHg difference, 95% CI 6.8, -2.2; p = 0.0001)
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833805
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin and glimepiride, liraglutide gave greater weight loss than placebo (treatment difference -1.39 kg).
In plain wordsIn adults with type 2 diabetes, people lost more weight with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
DecreaseBody weight
Study
n = 344
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
body weight treatment difference
−1.39 kg
liraglutide vs placebo
Source sentences
Summary
There was greater weight loss with liraglutide vs placebo (treatment difference -1.39 kg, 95% CI 2.10, 0.69; p = 0.0001)
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833803
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin and glimepiride, the systolic blood pressure reduction with liraglutide did not differ significantly from placebo.
In plain wordsIn adults with type 2 diabetes, liraglutide did not lower systolic blood pressure significantly more than placebo.
Peptide
Liraglutide
Outcome
No significant changeSystolic blood pressure
Study
n = 344
Comparator
Placebo
Outcome group
Blood pressure · Cardiovascular
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
but not vs placebo (p = 0.0791).
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833806
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin and glimepiride, hypoglycaemic episodes (major, minor, symptoms only) occurred at 0.06, 1.2 and 1.0 events per patient per year with liraglutide, versus 0, 1.3 and 1.8 with insulin glargine and 0, 1.0 and 0.5 with placebo.
In plain wordsIn adults with type 2 diabetes, major low blood sugar episodes were rare with liraglutide; rates for insulin glargine and placebo were also reported.
Peptide
Liraglutide
Outcome
Not applicableHypoglycaemic episode rates
Study
n: not reported in source
Comparator
Insulin glargine and placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
major hypoglycaemia rate
0.06 events/patient/year
liraglutide
minor hypoglycaemia rate
1.2 events/patient/year
liraglutide
symptoms-only hypoglycaemia rate
1 events/patient/year
liraglutide
major hypoglycaemia rate
0 events/patient/year
insulin glargine
minor hypoglycaemia rate
1.3 events/patient/year
insulin glargine
symptoms-only hypoglycaemia rate
1.8 events/patient/year
insulin glargine
major hypoglycaemia rate
0 events/patient/year
placebo
minor hypoglycaemia rate
1 events/patient/year
placebo
1 more measurement in the study.
Source sentences
Summary
Rates of hypoglycaemic episodes (major, minor and symptoms only, respectively) were 0.06, 1.2 and 1.0 events/patient/year, respectively, in the liraglutide group (vs 0, 1.3, 1.8 and 0, 1.0, 0.5 with glargine and placebo, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833807
08HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin and glimepiride, a slightly higher number of adverse events was reported with liraglutide.
In plain wordsIn adults with type 2 diabetes, slightly more side effects were reported with liraglutide.
Peptide
Liraglutide
Outcome
IncreaseAdverse events overall
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
A slightly higher number of adverse events (including nausea at 14%)
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833808
09HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin and glimepiride, nausea was reported at 14% with liraglutide.
In plain wordsIn adults with type 2 diabetes, 14% of people on liraglutide reported nausea.
Peptide
Liraglutide
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
nausea
14%
liraglutide
Source sentences
Summary
A slightly higher number of adverse events (including nausea at 14%)
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833809
10HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin and glimepiride, 9.8% of participants in the liraglutide group developed anti-liraglutide antibodies.
In plain wordsIn adults with type 2 diabetes, 9.8% of people on liraglutide developed antibodies against it.
Peptide
Liraglutide
Outcome
Not applicableAnti-liraglutide antibodies
Study
n: not reported in source
Outcome group
Immune response · Immune and inflammation
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
participants with anti-liraglutide antibodies
9.8%
liraglutide group
Source sentences
Summary
but only 9.8% of participants in the group receiving liraglutide developed anti-liraglutide antibodies.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomised (using a telephone or web-based randomisation system), parallel-group, controlled 26 week trial of 581 patients with type 2 diabetes mellitus on prior monotherapy (HbA(1c) 7.5-10%) and combination therapy (7.0-10%) was conducted in 107 centres in 17 countries.
Summary · context
Patients were randomised (2:1:2) to liraglutide 1.8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily).
Report a problemFND-1968833810

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 completed · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 3NCT03421119

Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes

Cinnagenn = 300est. 20 Jun 2019 to est. 1 Dec 2019

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 6 Feb 2019

CompletedPhase 3NCT00331851

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 584May 2006 to Apr 2007

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 26 Jan 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
12 Oct 2026, 12:10 UTC
Study results updated
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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