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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00592527

NN304-1569

Details and patient eligibility

About

This trial is conducted in Asia.

The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for at least 12 months since diagnosis
• Insulin naive subjects
• OAD treatment for at least 4 months with max. two OAD treatments
• Body mass index below 30.0 kg/m2
• HbA1c between 7.0-11.0%

Exclusion criteria

• OAD treatment with three or more OADs
• Secondary diabetes
• Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
• Uncontrolled hypertension
• Known or suspected allergy to trial product or related products

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)