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

Sponsor:	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. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glyburide Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Fasting Plasma Glucose After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
Fasting Plasma Glucose After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Postprandial Glucose AUC After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment
Postprandial Glucose AUC After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment
Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Body Weight After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
Body Weight After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Hypoglycaemic Episodes [ Time Frame: over 52 weeks of treatment ] [ Designated as safety issue: Yes ]
Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Enrollment:	400
Study Start Date:	November 2006
Study Completion Date:	May 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Liraglutide Liraglutide 0.9 mg + glibenclamide placebo	Drug: liraglutide 0.9 mg/day. Injected s.c. (under the skin) once daily. Other Name: NN2211 Drug: placebo glibenclamide placebo. Given orally once or twice daily.
Active Comparator: Glibenclamide Glibenclamide 1.25-2.5 mg + liraglutide placebo	Drug: glibenclamide 1.25-2.5 mg tablet. Given orally once or twice daily. Drug: placebo liraglutide placebo. Injected s.c. (under the skin) 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 (Body Mass Index) 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

Tokyo, 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 by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hegedüs L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. Epub 2011 Jan 5.

Seino Y, Rasmussen MF, Nishida T, Kaku K. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin. 2010 May;26(5):1013-22.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00393718 History of Changes
Other Study ID Numbers:	NN2211-1700, JAPIC: JapicCTI-060328
Study First Received:	October 27, 2006
Results First Received:	February 23, 2010
Last Updated:	March 29, 2010
Health Authority:	Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glyburide
Glucagon-Like Peptide 1

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012