NCT00318422|CompletedPhase 3

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

LEAD-1

Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN2211-14362005-003414-15

Study Type

interventional

Target

1,041

Locations

23 countries

Sites

127

Timeline

RegisteredApr 2006

StartedMay 2006

CompletionMay 2007

Brief Summary

This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

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

1,041

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started May 2006

Geographic Reach

23 countries

127 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

1 year 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

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed

Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

April 25, 2006

Last Update Submit

January 24, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c
after 26 weeks of treatment

Secondary Outcomes (4)

body weight
Safety and tolerability
beta-cell function
Glycemic control parameters (fasting plasma glucose, -glucose profiles)

Interventions

liraglutideDRUG

rosiglitazoneDRUG

glimepirideDRUG

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Treatment with oral anti-diabetic drugs 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 to 45.0 kg/m2.

You may not qualify if:

Treatment with insulin within the last three months
Treatment with any drug that could interfere with the glucose level
Any serious medical condition
Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

Contact the study team to confirm eligibility.