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

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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

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