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...
Date First Received: December 20, 2005
Last Updated: August 20, 2007
Verified by: Novo Nordisk, August 2007
Clinical Trial Phase: Phase 3 | Start Date: December 2005
Overall Status: Terminated
Estimated Enrollment: 336
Brief Summary
Official Title: “A Clinical Trial to Study the Efficacy and Safety of Thrice Daily Insulin Aspart Compared to Glibenclamide in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: insulin aspart
- Drug: glibenclamide
Outcome Measures for this Clinical Trial
Primary Measures
- HbA1c
- Time Frame: after 24 weeks of treatment
- Time Frame: after 24 weeks of treatment
Secondary Measures
- Plasma glucose levels
- Percentage of subjects achieving the treatment target of HbA1c value < 6.5%
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novo Nordisk
Overall Clinical Trial Officials and Contacts
Michiaki Kanai, DVM, MSc. Study Director Novo Nordisk Pharma Limited Japan
Additional Information
Information obtained from ClinicalTrials.gov on October 06, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00267683
Study ID Number: ANA-1667
ClinicalTrials.gov Identifier: NCT00267683
Health Authority: Japan: Ministry of Health, Labor and Welfare
Clinical Trials Authorship and Review
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