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

• Status: Terminated
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Glyburide; Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

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