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NCT00267683 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00267683
Other study ID # ANA-1667
Secondary ID JapicCTI-060200
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 2005
Est. completion date April 2006

Study information
Verified date October 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 9
Est. completion date April 2006
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin aspart

• glibenclamide

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 24 weeks of treatment
Secondary Plasma glucose levels
Secondary Percentage of subjects achieving the treatment target of HbA1c value < 6.5%
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