Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Type 1 diabetes

• Currently on basal-bolus regimen

• BMI = 35.0 kg/m2

• HbA1c =11.0%

Exclusion Criteria:

• Proliferative retinopathy or maculopathy

• Recurrent major hypoglycaemia

• Cardial problems

• Uncontrolled hypertension

• Impaired hepatic or renal function