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

Tracking Information

First Received Date ^ICMJE

May 30, 2006

Last Updated Date

June 25, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

HbA1c after 26 weeks of treatment

Change History

Complete list of historical versions of study NCT00331851 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

body weight [ Designated as safety issue: No ]
Safety and tolerability [ Designated as safety issue: No ]
Beta-cell function [ Designated as safety issue: No ]
Glycaemic control [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

body weight
Safety and tolerability
Beta-cell function
Glycaemic control

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Investigator)
Primary Purpose:  Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: liraglutide
Drug: insulin glargine
Drug: metformin
Drug: glimepiride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

584

Completion Date

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Austria, Brazil, Denmark, Finland, France, India, Italy, Netherlands, Norway, Philippines, Poland, Russian Federation, Slovakia, South Africa, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00331851

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

NN2211-1697

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Milan Zdravkovic, MD, Ph.D

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP