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

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00331851

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: liraglutide Drug: insulin glargine Drug: metformin Drug: glimepiride	Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Insulin human Glimepiride Insulin glargine Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	584
Study Start Date:	May 2006
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331851

Show 17 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Milan Zdravkovic, MD, Ph.D

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. Epub 2011 Mar 30.

Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simó R; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2046-55. Epub 2009 Aug 14.

Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00331851 History of Changes
Other Study ID Numbers:	NN2211-1697
Study First Received:	May 30, 2006
Last Updated:	June 25, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency Spain: Spanish Agency of Medicines Slovakia: State Institute for Drug Control Russia: Pharmacological Committee, Ministry of Health Denmark: Danish Medicines Agency Poland: Ministry of Health Finland: Finnish Medicines Agency San Marino: Agency for Drugs and Medicinal Devices South Africa: Medicines Control Council Netherlands: Dutch Health Care Inspectorate Austria: Federal Ministry for Health and Women Argentina: Endocrinology, Diabetes and Metabolism Disorders Institute, Centre for Metabolic Disorders, Intensive Treatment and Cell Theraphy" Brazil: National Health Surveillance Agency Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Philippines: Bureau of Food and Drugs Norway: Norwegian Medicines Agency India: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glargine
Insulin
Metformin

Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012