NCT00331851|CompletedPhase 3

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

LEAD-5

Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

Novo Nordisk A/S ClinicalTrials.gov

Compare

1 other identifier

NN2211-1697

Study Type

interventional

Target

584

Locations

18 countries

Sites

116

Timeline

RegisteredMay 2006

StartedMay 2006

CompletionApr 2007

Brief Summary

This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

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

584

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started May 2006

Shorter than P25 for phase_3 diabetes

Geographic Reach

18 countries

116 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

11 months study duration

Study Start

First participant enrolled

May 1, 2006

Completed

29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed

Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

May 30, 2006

Last Update Submit

January 25, 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
Glycaemic control

Interventions

liraglutideDRUG

insulin glargineDRUG

metforminDRUG

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: 7.5-10.0 % (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 kg/m2

You may not qualify if:

Treatment with insulin within the last 3 months
Treatment with any drug that could interfere with the glucose level
Any serious medical condition
Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Contact the study team to confirm eligibility.