NCT00318461|CompletedPhase 3Results

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

LEAD-2

Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN2211-1572

Study Type

interventional

Target

1,091

Locations

20 countries

Sites

190

Timeline

RegisteredApr 2006

StartedMay 2006

CompletionNov 2008

Brief Summary

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,091

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started May 2006

Longer than P75 for phase_3 diabetes

Geographic Reach

20 countries

190 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

April 25, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed

5 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

March 12, 2010

Completed

Last Updated

March 7, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

April 25, 2006

Results QC Date

February 23, 2010

Last Update Submit

January 24, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Change in Glycosylated A1c (HbA1c) at Week 26
Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Glycosylated A1c (HbA1c) at Week 104
Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)
week 0, week 104

Secondary Outcomes (12)

Change in Body Weight at Week 26
week 0, week 26
Change in Body Weight at Week 104
week 0, week 104
Change in Fasting Plasma Glucose (FPG) at Week 26
week 0, week 26
Change in Fasting Plasma Glucose (FPG) at Week 104
week 0, week 104
Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
week 0, week 26
+7 more secondary outcomes

Study Arms (5)

Lira 0.6 + Met

EXPERIMENTAL

Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Drug: liraglutideDrug: metforminDrug: placebo

Lira 1.2 + Met

EXPERIMENTAL

Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Drug: metforminDrug: placeboDrug: liraglutide

Lira 1.8 + Met

EXPERIMENTAL

Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Drug: metforminDrug: placeboDrug: liraglutide

Met Mono

ACTIVE COMPARATOR

Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo

Drug: metforminDrug: placebo

Met + Glim

ACTIVE COMPARATOR

Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo

Drug: metforminDrug: glimepirideDrug: placebo

Interventions

liraglutideDRUG

0.6 mg for s.c. (under the skin) injection.

Lira 0.6 + Met

metforminDRUG

1.5-2.0 g tablets

Lira 0.6 + MetLira 1.2 + MetLira 1.8 + MetMet + GlimMet Mono

glimepirideDRUG

4 mg tablets

Met + Glim

placeboDRUG

Glimepiride placebo 1 mg and 2 mg tablets

Lira 0.6 + MetLira 1.2 + MetLira 1.8 + MetMet Mono

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
Body Mass Index (BMI) less than or equal 40 kg/m2

You may not qualify if:

Subjects treated with insulin within the last three months
Subjects with any serious medical condition
Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)

Contact the study team to confirm eligibility.