To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00294723

Purpose

Double blind trial with two open label extensions conducted in the United States of America (USA) and Mexico.

Trial dates:

Original trial: Start February 2006, finish November 2007 First extension: Start March 2007, finish November 2008 Second extension: Start March 2008, finish November 2011 The trial is designed to evaluate the effects of treatment with liraglutide versus glimipiride in subjects with type 2 diabetes

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

MedlinePlus related topics: Diabetes

Drug Information available for: 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 3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in HbA1c [ Time Frame: after 52 weeks, after 104 weeks and after 245 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body weight [ Time Frame: after 52 weeks, after 104 weeks and after 245 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
Glycemic Control [ Time Frame: after 52 weeks, after 104 weeks and after 245 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	175
Study Start Date:	February 2006
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: liraglutide 1.2 mg for s.c. injection
B: Experimental	Drug: liraglutide 1.8 mg for s.c. injection
C: Active Comparator	Drug: glimepiride 8 mg capsule, low dose
D: Active Comparator	Drug: glimepiride 8 mg capsule, high dose

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 diet/exercise or with oral anti-diabetic drugs alone for at least 2 months
Diet/exercise treated subjects with HbA1c > 7.0% and < 11%
OAD treated subjects with HbA1c > 7.0% and < 10%
Body Mass Index (BMI) less than or equal to 45 kg/m2

Exclusion Criteria:

Treatment with insulin for the last 3 months
Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
Any serious medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294723

Show 110 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Paula Hale, MD

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:	NN2211-1573
Study First Received:	February 20, 2006
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00294723
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks; United States: Food and Drug Administration

Study placed in the following topic categories:

Glimepiride
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

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 16, 2009