Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01486940

NN304-1374

Details and patient eligibility

About

This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

Enrollment: 598 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for at least 12 months
• Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
• BMI below or equal to 35 kg/m^2
• HbA1c below or equal to 12%

Exclusion criteria

• Proliferative retinopathy or maculopathy requiring acute treatment
• Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
• Subjects with known hypoglycaemic unawareness as judged by the Investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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598 participants in 2 patient groups

Basal/bolus regimen 1

Experimental group

Treatment:

Drug: insulin detemir

Drug: insulin aspart

Basal/bolus regimen 2

Active Comparator group

Treatment:

Drug: insulin NPH

Drug: human soluble insulin