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

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

Purpose

Double blind trial with an open label extension conducted in the United States of America (USA) and Mexico. A second open label extension is registered, for internal administrative purposes only, as NN2211-3529.

Trial dates:

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	762
Study Start Date:	February 2006
Study Completion Date:	November 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: liraglutide 1.2 mg for s.c. injection Drug: placebo Glimepiride placebo, 8mg capsule
B: Experimental	Drug: liraglutide 1.8 mg for s.c. injection Drug: placebo Glimepiride placebo, 8mg capsule
C1: Active Comparator	Drug: glimepiride 8 mg capsule Drug: placebo Liraglutide placebo, 200 microL
C2: Active Comparator	Drug: glimepiride 8 mg capsule Drug: placebo Liraglutide placebo, 300 microL

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 between 7.0% and 11%
OAD treated subjects with HbA1c between 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 109 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Paula Hale, MD

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 National Clinical Trials Identifier (NCT ID):

Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I, Hale PM, Zdravkovic M, Bode B; LEAD-3 (Mono) Study Group. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009 Feb 7;373(9662):473-81. Epub 2008 Sep 24.

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN2211-1573
Study First Received:	February 20, 2006
Last Updated:	November 9, 2009
ClinicalTrials.gov Identifier:	NCT00294723 History of Changes
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks; United States: Food and Drug Administration

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Hormones
Immunosuppressive Agents

Pharmacologic Actions
Glucagon-Like Peptide 1
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Incretins
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010