Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-5) - Full Text View

Sponsored by:	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 III

MedlinePlus related topics: Diabetes

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 26 weeks of treatment ]

Secondary Outcome Measures:

body weight
Safety and tolerability
Beta-cell function
Glycaemic control

Estimated Enrollment:	570
Study Start Date:	May 2006

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

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN2211-1697
Study First Received:	May 30, 2006
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00331851
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: National Agency for Medicines; 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: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; 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

Study placed in the following topic categories:

Glimepiride
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Agents
Anti-Arrhythmia Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009