Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00393718

Purpose

This trial is conducted in Japan.

The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1C after 24 and 52 weeks in subjects with type 2 diabetes.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Glyburide Liraglutide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1C [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body weight [ Time Frame: after 24 and 52 weeks of treatment ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Glycaemic control parameters [ Time Frame: after 24 and 52 weeks of treatment ] [ Designated as safety issue: No ]
HbA1C [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	378
Study Start Date:	October 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: liraglutide 0.9 mg/day. Injected s.c. once daily. Drug: placebo glibenclamide placebo. Given orally once or twice daily.
B: Active Comparator	Drug: glibenclamide 1.25-2.5 mg tablet. Given orally once or twice daily. Drug: placebo liraglutide placebo. Injected s.c. once daily.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes
Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks
HbA1C greater than or equal to 7.0% and less than 10.0%
BMI less than 35 kg/m2

Exclusion Criteria:

Treatment with insulin within the last 12 weeks
Treatment with any drug that could interfere with the glucose level
Any serious medical condition
Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393718

Locations

Japan

Osaka, Japan

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Yasuyuki Katayama, MD	Novo Nordisk Pharma Ltd.
Study Director:	Hiroko Terano	Novo Nordisk Pharma Ltd.

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:	NN2211-1700, JAPIC: JapicCTI-060328
Study First Received:	October 27, 2006
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00393718 History of Changes
Health Authority:	Japan: Ministry of Health, Labour and Welfare (MHLW)

Study placed in the following topic categories:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009