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

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin aspart; Drug: glibenclamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00267683

ANA-1667

JapicCTI-060200 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)