Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study.

Nauck M, Frid A, Hermansen K, Thomsen AB, During M, Shah N, Tankova T, Mitha I, Matthews DR

Diabetes, obesity & metabolism11 Oct 2012Cited by 122 (Europe PMC)

PMID22985213DOI10.1111/dom.12012PepBankPUB-22985213

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 study12

12 results from studies that gave the peptide. 12 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, liraglutide 0.6 mg lowered HbA1c by 0.4% over 2 years, while HbA1c rose 0.3% with metformin monotherapy.
In plain wordsIn adults with type 2 diabetes on metformin, adding liraglutide 0.6 mg lowered HbA1c, while metformin alone did not.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change, liraglutide 0.6 mg versus metformin monotherapy
Study
n: not reported in source
Comparator
Placebo plus metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg once daily · 2 yearsAs given in this study (human).
Measurements
HbA1c decrease
0.4%
liraglutide 0.6 mg
HbA1c increase
0.3%
metformin monotherapy
Source sentences
Summary
HbA1c decreased significantly with liraglutide (0.4% with 0.6 mg, 0.6% with 1.2 and 1.8 mg) versus 0.3% increase with metformin monotherapy (p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521301
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, liraglutide 1.2 mg lowered HbA1c by 0.6% over 2 years, while HbA1c rose 0.3% with metformin monotherapy.
In plain wordsIn adults with type 2 diabetes on metformin, adding liraglutide 1.2 mg lowered HbA1c, while metformin alone did not.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change, liraglutide 1.2 mg versus metformin monotherapy
Study
n: not reported in source
Comparator
Placebo plus metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 mg once daily · 2 yearsAs given in this study (human).
Measurements
HbA1c decrease
0.6%
liraglutide 1.2 mg
HbA1c increase
0.3%
metformin monotherapy
Source sentences
Summary
HbA1c decreased significantly with liraglutide (0.4% with 0.6 mg, 0.6% with 1.2 and 1.8 mg) versus 0.3% increase with metformin monotherapy (p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521302
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, liraglutide 1.8 mg lowered HbA1c by 0.6% over 2 years, while HbA1c rose 0.3% with metformin monotherapy.
In plain wordsIn adults with type 2 diabetes on metformin, adding liraglutide 1.8 mg lowered HbA1c, while metformin alone did not.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change, liraglutide 1.8 mg versus metformin monotherapy
Study
n: not reported in source
Comparator
Placebo plus metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 2 yearsAs given in this study (human).
Measurements
HbA1c decrease
0.6%
liraglutide 1.8 mg
HbA1c increase
0.3%
metformin monotherapy
Source sentences
Summary
HbA1c decreased significantly with liraglutide (0.4% with 0.6 mg, 0.6% with 1.2 and 1.8 mg) versus 0.3% increase with metformin monotherapy (p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521303
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, the HbA1c decrease with liraglutide was non-inferior to the 0.5% decrease with glimepiride.
In plain wordsIn adults with type 2 diabetes on metformin, liraglutide lowered HbA1c about as well as glimepiride.
Peptide
Liraglutide
Outcome
No significant changeHbA1c decrease versus glimepiride (non-inferiority)
Study
n: not reported in source
Comparator
Glimepiride plus metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6, 1.2 or 1.8 mg once daily · 2 yearsAs given in this study (human).
Measurements
HbA1c decrease
0.5%
glimepiride
Source sentences
Summary
HbA1c decrease with liraglutide was non-inferior versus 0.5% decrease with glimepiride.
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521304
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, liraglutide 0.6 mg gave 2.1 kg weight loss, compared with 0.7 kg weight gain with glimepiride.
In plain wordsIn adults with type 2 diabetes on metformin, liraglutide 0.6 mg led to weight loss, while glimepiride led to weight gain.
Peptide
Liraglutide
Outcome
DecreaseWeight change, liraglutide 0.6 mg versus glimepiride
Study
n: not reported in source
Comparator
Glimepiride plus metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
0.6 mg once daily · 2 yearsAs given in this study (human).
Measurements
Weight loss
2.1 kg
liraglutide 0.6 mg
Weight gain
0.7 kg
glimepiride
Source sentences
Summary
Liraglutide groups experienced significant weight loss (2.1, 3.0 and 2.9 kg with 0.6, 1.2 and 1.8 mg, respectively) compared to weight gain (0.7 kg) with glimepiride (p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521305
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, liraglutide 1.2 mg gave 3.0 kg weight loss, compared with 0.7 kg weight gain with glimepiride.
In plain wordsIn adults with type 2 diabetes on metformin, liraglutide 1.2 mg led to weight loss, while glimepiride led to weight gain.
Peptide
Liraglutide
Outcome
DecreaseWeight change, liraglutide 1.2 mg versus glimepiride
Study
n: not reported in source
Comparator
Glimepiride plus metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg once daily · 2 yearsAs given in this study (human).
Measurements
Weight loss
3 kg
liraglutide 1.2 mg
Weight gain
0.7 kg
glimepiride
Source sentences
Summary
Liraglutide groups experienced significant weight loss (2.1, 3.0 and 2.9 kg with 0.6, 1.2 and 1.8 mg, respectively) compared to weight gain (0.7 kg) with glimepiride (p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521306
07HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, liraglutide 1.8 mg gave 2.9 kg weight loss, compared with 0.7 kg weight gain with glimepiride.
In plain wordsIn adults with type 2 diabetes on metformin, liraglutide 1.8 mg led to weight loss, while glimepiride led to weight gain.
Peptide
Liraglutide
Outcome
DecreaseWeight change, liraglutide 1.8 mg versus glimepiride
Study
n: not reported in source
Comparator
Glimepiride plus metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
1.8 mg once daily · 2 yearsAs given in this study (human).
Measurements
Weight loss
2.9 kg
liraglutide 1.8 mg
Weight gain
0.7 kg
glimepiride
Source sentences
Summary
Liraglutide groups experienced significant weight loss (2.1, 3.0 and 2.9 kg with 0.6, 1.2 and 1.8 mg, respectively) compared to weight gain (0.7 kg) with glimepiride (p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521307
08HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, weight loss with liraglutide 1.2 mg was significantly greater than with metformin monotherapy (1.8 kg).
In plain wordsIn adults with type 2 diabetes on metformin, liraglutide 1.2 mg led to more weight loss than metformin alone.
Peptide
Liraglutide
Outcome
DecreaseWeight loss, liraglutide 1.2 mg versus metformin monotherapy
Study
n: not reported in source
Comparator
Placebo plus metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg once daily · 2 yearsAs given in this study (human).
Measurements
Weight loss
1.8 kg
metformin monotherapy
Source sentences
Summary
Weight loss with liraglutide 1.2 and 1.8 mg was significantly greater than with metformin monotherapy (1.8 kg; p = 0.0185 and p = 0.0378 for 1.2 and 1.8 mg, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521308
09HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, weight loss with liraglutide 1.8 mg was significantly greater than with metformin monotherapy (1.8 kg).
In plain wordsIn adults with type 2 diabetes on metformin, liraglutide 1.8 mg led to more weight loss than metformin alone.
Peptide
Liraglutide
Outcome
DecreaseWeight loss, liraglutide 1.8 mg versus metformin monotherapy
Study
n: not reported in source
Comparator
Placebo plus metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
1.8 mg once daily · 2 yearsAs given in this study (human).
Measurements
Weight loss
1.8 kg
metformin monotherapy
Source sentences
Summary
Weight loss with liraglutide 1.2 and 1.8 mg was significantly greater than with metformin monotherapy (1.8 kg; p = 0.0185 and p = 0.0378 for 1.2 and 1.8 mg, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521309
10HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin, minor hypoglycaemia occurred in under 5.0% of all liraglutide groups, significantly less than with glimepiride (24.0%).
In plain wordsIn adults with type 2 diabetes on metformin, mild low blood sugar was less common with liraglutide than with glimepiride.
Peptide
Liraglutide
Outcome
DecreaseMinor hypoglycaemia versus glimepiride
Study
n: not reported in source
Comparator
Glimepiride plus metformin
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.6, 1.2 or 1.8 mg once daily · 2 yearsAs given in this study (human).
Measurements
Minor hypoglycaemia
< 5%
all liraglutide groups
Minor hypoglycaemia
24%
glimepiride
Source sentences
Summary
The occurrence of minor hypoglycaemia was <5.0% in all liraglutide groups, significantly less than with glimepiride (24.0%; p < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521310
11HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin, gastrointestinal events were more common with liraglutide than with glimepiride, but occurrence decreased with time.
In plain wordsIn adults with type 2 diabetes on metformin, gut side effects were more common with liraglutide than glimepiride, but became less frequent over time.
Peptide
Liraglutide
Outcome
IncreaseGastrointestinal events versus glimepiride
Study
n: not reported in source
Comparator
Glimepiride plus metformin
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.6, 1.2 or 1.8 mg once daily · 2 yearsAs given in this study (human).
Source sentences
Summary
gastrointestinal events were more common than with glimepiride or metformin monotherapy, but occurrence decreased with time.
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521311
12HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin, gastrointestinal events were more common with liraglutide than with metformin monotherapy, but occurrence decreased with time.
In plain wordsIn adults with type 2 diabetes on metformin, gut side effects were more common with liraglutide than metformin alone, but became less frequent over time.
Peptide
Liraglutide
Outcome
IncreaseGastrointestinal events versus metformin monotherapy
Study
n: not reported in source
Comparator
Placebo plus metformin
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.6, 1.2 or 1.8 mg once daily · 2 yearsAs given in this study (human).
Source sentences
Summary
gastrointestinal events were more common than with glimepiride or metformin monotherapy, but occurrence decreased with time.
1 context sentence(design, population, supporting numbers)
Summary · context
In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin.
Report a problemFND-2298521312

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 postedNCT00318461

To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together

Novo Nordisk A/Sn = 1,091May 2006 to Nov 2008

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 7 Mar 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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