Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin detemir

Drug: insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00283751

NN304-1373

Details and patient eligibility

About

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

Enrollment

583 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 Diabetes for more than 12 months, and no previous insulin treatment
Oral Antidiabetic Drug treatment for at least 4 months
Body Mass Index (BMI) less than 40 kg/m2
HbA1c 7.5-10.0%

Exclusion criteria

Current or previous treatment with thiazolidinediones within the last 6 months
Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
Proliferative retinopathy or maculopathy
Known hypoglycaemia unawareness