Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00184665

NN304-1595

Details and patient eligibility

About

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).

Enrollment: 501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes
• Currently on basal-bolus regimen
• BMI = 35.0 kg/m2
• HbA1c =11.0%

Exclusion criteria

• Proliferative retinopathy or maculopathy
• Recurrent major hypoglycaemia
• Cardial problems
• Uncontrolled hypertension
• Impaired hepatic or renal function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)