Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

• Status: Completed
• Trial end date: 2004-10-07
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe.

The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

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

Details

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

Criteria

Inclusion Criteria:

• Duration of type 1 diabetes for at least 12 months

• BMI below 35 kg/m2

• HbA1c between 7.0-12.0%

• Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months

• Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

Exclusion Criteria:

• Known or suspected allergy to trial product or related products

• Previous participation in this trial

• Receipt of any investigational products within the last 2 months prior to this trial

• Drug or alcohol dependence

• Pregnancy, breast-feeding or intention of becoming pregnant