Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin aspart; Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537303

2007-000123-18 (EudraCT Number)

NN304-1833

Details and patient eligibility

About

This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Enrollment: 296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus for more than 6 months
• HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
• BMI (Body Mass Index) less than 40 kg/m2
• Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
• Treatment with one to 3 OADs

Exclusion criteria

• Known or suspected allergy to trial products or related products
• Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
• Previous participation in any trial including this for the last 6 months
• Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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296 participants in 2 patient groups

Advanced

Experimental group

Description:

Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Treatment:

Drug: insulin detemir

Drug: insulin aspart

Drug: insulin aspart

Basic

Active Comparator group

Description:

Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Treatment:

Drug: insulin detemir

Drug: insulin aspart

Drug: insulin aspart