Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes (PREDICTIVE™)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin NPH; Drug: insulin detemir; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00504673

2005-000976-42 (EudraCT Number)

NN304-1659

Details and patient eligibility

About

This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.

Enrollment: 277 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HbA1c: 7.5-11.0%
• BMI: 25-40 kg/m2

Exclusion criteria

• Treatment with any OAD (Oral Antidiabetic Drugs) except metformin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)