Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.

• 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:

• Duration of type 2 diabetes mellitus for at least one year

• Insulin naive patients

• OHA treatment for at least 12 weeks

• HbA1C between 7.5-10.0%

• Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

• Impaired renal function

• Impaired hepatic function

• Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods