Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes

This study has been terminated.

( Slow recruitment )

First Received: December 20, 2005 Last Updated: October 2, 2009 History of Changes

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00267683

Purpose

This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin aspart Drug: glibenclamide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Clinical Trial to Study the Efficacy and Safety of Insulin Aspart Three Times Per Day Compared to Glibenclamide Once or Twice Daily in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glyburide Insulin Insulin aspart

U.S. FDA Resources

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:

Plasma glucose levels [ Designated as safety issue: No ]
Percentage of subjects achieving the treatment target of HbA1c value < 6.5% [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	December 2005
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

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 therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks
No previous treatment with insulin and/or SU agents
HbA1c > 7.5% and <10.0%
Body Mass Index (BMI) < 30.0 kg/m2

Exclusion Criteria:

Proliferative retinopathy or maculopathy requiring acute treatment
Impaired hepatic function
Impaired renal function
Cardiac diseases
Uncontrolled hypertension
Known hypoglycaemia unawareness or recurrent major hypoglycaemia
Current treatment with systemic corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267683

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Michiaki Kanai, DVM, MSc.

Novo Nordisk Pharma Limited Japan

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:	ANA-1667, JAPIC: JapicCTI-060200
Study First Received:	December 20, 2005
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00267683 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on February 08, 2010