Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

• Status: Completed
• Trial end date: 2001-11-12
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

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

Details

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

Criteria

Inclusion Criteria:

• Signed and dated informed consent obtained before any trial-related activities

• Type 1 diabetes diagnosed and classified according to aetiology

• Duration of type 1 diabetes equal to or more than 12 months

• Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory

• Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

• Proliferative retinopathy

• Total basal insulin dose of more than 100 IU per day

• Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)

• Known unawareness of hypoglycaemia

• Previous treatment with insulin detemir