Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00614120

Purpose

This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control 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:

Change in Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body weight [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
Fasting blood glucose [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
7-point plasma glucose profiles (self-measured) [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
Beta-cell function and lipid profile [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
Hyperglycaemic episodes [ Time Frame: over 16 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	929
Study Start Date:	January 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lira 0.6 + Met: Experimental Liraglutide 0.6 mg + metformin + glimepiride placebo	Drug: liraglutide 0.6 mg/day, s.c. (under the skin) injection Drug: placebo Glimepiride placebo, capsules Drug: metformin Tablets, 1.5-2.0 g/day
Lira 1.2 + Met: Experimental Liraglutide 1.2 mg + metformin + glimepiride placebo	Drug: placebo Glimepiride placebo, capsules Drug: liraglutide 1.2 mg/day, s.c. (under the skin) injection Drug: metformin Tablets, 1.5-2.0 g/day
Lira 1.8 + Met: Experimental Liraglutide + metformin + glimepiride placebo	Drug: placebo Glimepiride placebo, capsules Drug: liraglutide 1.8 mg/day, s.c. (under the skin) injection Drug: metformin Tablets, 1.5-2.0 g/day
Glim + Met: Experimental Glimepiride 4.0 mg + metformin + liraglutide placebo	Drug: glimepiride Capsules, 4.0 mg/day Drug: metformin Tablets, 1.5-2.0 g/day Drug: placebo Liraglutide placebo, s.c. (under the skin) injection

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
Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
BMI less than 45.0 kg/m2

Exclusion Criteria:

Treatment with insulin within the last 3 months prior to the trial
Impaired liver or/and renal function
Significant cardiovascular disease over the last 6 months
Known retinopathy or maculopathy
Recurrent major hypoglycaemia or hypoglycaemic unawareness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614120

Locations

China

Shanghai, China, 200003
China, Beijing

Beijing, Beijing, China, 100029
India, a.P

Hyderabad, a.P, India, 500 001
Korea, Republic of, Gyeongi-do

Sungnam, Gyeongi-do, Korea, Republic of, 463-707

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Marcin Zychma, MD, PhD

Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN2211-1796
Study First Received:	January 15, 2008
Last Updated:	November 30, 2009
ClinicalTrials.gov Identifier:	NCT00614120 History of Changes
Health Authority:	China: State Food and Drug Administration; South Korea: Korea Food and Drug Administration (KFDA); India: Ministry of Health

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 February 08, 2010