NCT00294723|TerminatedPhase 3Results

Study Stopped

The trial was terminated at week 195 due to an insufficient number of subjects remaining to obtain reasonable statistical power

To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c

LEAD-3

Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN2211-1573

Study Type

interventional

Target

746

Locations

3 countries

Sites

117

Timeline

RegisteredFeb 2006

StartedFeb 2006

CompletionNov 2008

Brief Summary

This trial is conducted in North America (the United States of America (USA) and Mexico). The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

Trial Health

Monitor

Trial Health Score

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

Enrollment

746

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Feb 2006

Longer than P75 for phase_3 diabetes

Geographic Reach

3 countries

117 active sites

Status

terminated

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

2.8 years study duration

Study Start

First participant enrolled

February 1, 2006

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed

Same day 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

2.8 years

First QC Date

February 20, 2006

Results QC Date

February 23, 2010

Last Update Submit

January 24, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)
week 0, week 52
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)
week 0, week 104
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks
week 0, week 156

Secondary Outcomes (14)

Change in Body Weight at Week 52
week 0, week 52
Change in Body Weight at Week 104
week 0, week 104
Change in Body Weight at Week 156
week 0, week 156
Change in Fasting Plasma Glucose at Week 52
week 0, week 52
Change in Fasting Plasma Glucose at Week 104
week 0, week 104
+9 more secondary outcomes

Study Arms (4)

Lira 1.8

EXPERIMENTAL

Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).

Drug: liraglutideDrug: placebo

Lira 1.2

EXPERIMENTAL

Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).

Drug: liraglutideDrug: placebo

Glimepiride - 1

ACTIVE COMPARATOR

Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).

Drug: glimepirideDrug: placebo

Glimepiride - 2

ACTIVE COMPARATOR

Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).

Drug: glimepirideDrug: placebo

Interventions

liraglutideDRUG

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

Lira 1.8

glimepirideDRUG

8 mg capsule

Glimepiride - 1Glimepiride - 2

placeboDRUG

Glimepiride placebo, 8mg capsule

Lira 1.2Lira 1.8

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months
Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive
OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive
Body Mass Index (BMI) less than or equal to 45 kg/m\^2

You may not qualify if:

Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness
Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
Any serious medical condition

Contact the study team to confirm eligibility.