Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: NPH insulin; Drug: Insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT03220425

NN304-1335

Details and patient eligibility

About

The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

Enrollment: 752 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent obtained before any trial-related activities
• Type 1 diabetes diagnosed and classified according to aetiology
• Duration of type 1 diabetes equal to or more than 12 months
• Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
• Able and willing to perform self-blood glucose monitoring

Exclusion criteria

• Proliferative retinopathy
• Total basal insulin dose of more than 100 IU per day
• Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
• Known unawareness of hypoglycaemia
• Previous treatment with insulin detemir

Trial design

752 participants in 2 patient groups

Insulin detemir

Experimental group

Treatment:

Drug: Insulin detemir

NPH insulin

Active Comparator group

Treatment:

Drug: NPH insulin