To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00318461

Purpose

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride.

The 26 weeks double-blind period will be followed by an 18 months open label extension.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: liraglutide Drug: metformin 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-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Liraglutide Metformin Metformin hydrochloride

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 [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Glycaemic control parameters (fasting plasma glucose, 7-point glucose profiles) [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Beta-cell function [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	1091
Study Start Date:	May 2006
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: liraglutide 0.6 mg for s.c. injection. Drug: metformin 1.5-2.0 g tablets Drug: placebo Glimepiride placebo 1 mg and 2 mg tablets
B: Active Comparator	Drug: metformin 1.5-2.0 g tablets Drug: placebo Glimepiride placebo 1 mg and 2 mg tablets Drug: liraglutide 1.2 mg for s.c. injection
C: Active Comparator	Drug: metformin 1.5-2.0 g tablets Drug: placebo Glimepiride placebo 1 mg and 2 mg tablets Drug: liraglutide 1.8 mg for s.c. injection
D: Active Comparator	Drug: metformin 1.5-2.0 g tablets Drug: placebo Glimepiride placebo 1 mg and 2 mg tablets Drug: placebo Liraglutide placebo 1-3 mL for s.c. injection
E: Active Comparator	Drug: metformin 1.5-2.0 g tablets Drug: glimepiride 4 mg tablets Drug: placebo Liraglutide placebo 1-3 mL for s.c. injection

Eligibility

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

Criteria

Inclusion Criteria:

Subjects diagnosed with type 2 diabetes and treated with OAD(s) 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 40 kg/m2

Exclusion Criteria:

Subjects treated with insulin within the last three months
Subjects with any serious medical condition
Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318461

Show 21 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Martin Lange

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):

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.

Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, Düring M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. Epub 2008 Oct 17.

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN2211-1572
Study First Received:	April 25, 2006
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00318461 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; Croatia: Ministry of Health and Social Care; Russia: Pharmacological Committee, Ministry of Health; Denmark: Danish Medicines Agency; Romania: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Bulgaria: Bulgarian Drug Agency; South Africa: Medicines Control Council; Netherlands: Dutch Health Care Inspectorate; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Ireland: Irish Medicines Board; Australia: Department of Health and Ageing Therapeutic Goods Administration; Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency; India: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Metformin
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 November 09, 2009