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

This study has been terminated.

( This trial was terminated due to low recruitment )

First Received on December 20, 2005. Last Updated on September 23, 2011 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

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

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Glyburide Insulin Insulin beef 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 between 7.5% and 10.0%
Body Mass Index (BMI) below 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:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00267683 History of Changes
Other Study ID Numbers:	ANA-1667, JapicCTI-060200
Study First Received:	December 20, 2005
Last Updated:	September 23, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart

Glyburide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012