Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.

• 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:

• Type 2 diabetes for at least 12 months since diagnosis

• Insulin naive subjects

• OAD treatment for at least 4 months alone or combined with no more than two OADs

• Body mass index (BMI) below 35.0 kg/m2

• HbA1c between 7.5-10.0%

• Able and willing to use twice a day injections for the entire trial period

Exclusion Criteria:

• Current or previous treatment with thiazolidiones within the last 6 months

• OAD treatment with three or more OADs within the last 6 months

• Acute insulin treatment for longer than 7 days in a row within the last 6 months

• Secondary diabetes

• Known maturity onset of diabetes of young (MODY)

• Known or suspected allergy to trial product or related products