Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-4)

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00333151

First received: June 1, 2006

Last updated: June 19, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 1, 2006

Last Updated Date

June 19, 2012

Start Date ^ICMJE

May 2006

Primary Completion Date

August 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 NCT00333151 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 ]
Glycaemic control [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

body weight
Safety and tolerability
Glycaemic control

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes

Brief Summary

This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: liraglutide
Drug: rosiglitazone
Drug: metformin

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

576

Completion Date

August 2007

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 diabetes
Treated with oral anti-diabetic (OAD) drugs for at least 3 months
Treated with one or more OAD and in moderate to poor glycemic control
Body Mass Index (BMI) less than or equal to 45.0 kg/m2

Exclusion Criteria:

Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator
Any serious medical condition
Treatment with any drug that could interfere with glucose level

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

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00333151

Other Study ID Numbers ^ICMJE

NN2211-1574

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Paula Hale, MD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2012

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

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