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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin NPH

Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00604396

NN304-1530

Details and patient eligibility

About

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.

Enrollment

477 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 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