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

Phase 3

Terminated

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00267683
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-20
• Study First Submitted QC: 2005-12-20
• Study First Posted: 2005-12-21
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 24 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects achieving the treatment target of HbA1c value < 6.5%
Plasma glucose levels