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:	NCT00318422

Purpose

This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: liraglutide Drug: rosiglitazone Drug: glimepiride	Phase III

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-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

Resource links provided by NLM:

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

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glimepiride Rosiglitazone Rosiglitazone Maleate 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 ]
Glycemic control parameters (fasting plasma glucose, -glucose profiles) [ Designated as safety issue: No ]

Enrollment:	1041
Study Start Date:	May 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 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: 7.0-11.0 % (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 45.0 kg/m2.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318422

Show 24 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):

Hegedüs L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. Epub 2011 Jan 5.

Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15.

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:	NCT00318422 History of Changes
Other Study ID Numbers:	NN2211-1436, 2005-003414-15
Study First Received:	April 25, 2006
Last Updated:	April 29, 2010
Health Authority:	Bulgaria: Bulgarian Drug Agency; France: Afssaps - French Health Products Safety Agency; Taiwan: Department of Health; Spain: Spanish Agency of Medicines; Croatia: Ministry of Health and Social Care; Turkey: Ministry of Health Drug and Pharmaceutical Department; Poland: Ministry of Health; Romania: National Medicines Agency; Finland: Finnish Medicines Agency; South Africa: Medicines Control Council; Czech Republic: State Institute for Drug Control; New Zealand: Food Safety Authority; South Korea: Korea Food and Drug Administration (KFDA); Israel: Israeli Health Ministry Pharmaceutical Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia; Brazil: National Health Surveillance Agency; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Switzerland: Swissmedic; Philippines: Bureau of Food and Drugs; Australia: Department of Health and Ageing Therapeutic Goods Administration; Greece: National Organization of Medicines; Thailand: Ministry of Public Health; India: Ministry of Health; Malaysia: Ministry of Health; Hong Kong: Department of Health

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Rosiglitazone
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 February 09, 2012