Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes (BOOST™)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin degludec/insulin aspart; Drug: insulin aspart; Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00978627

U1111-1113-2475 (Other Identifier)

NN5401-3594

U1111-1111-8943 (Other Identifier)

2009-013412-13 (EudraCT Number)

2008-005769-71 (EudraCT Number)

Details and patient eligibility

About

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

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

Enrollment: 548 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• FOR THE MAIN TRIAL, NN5401-3594:
• Type 1 diabetes mellitus for at least 12 months
• Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
• HbA1c 7.0-10.0% (both inclusive)
• BMI (Body Mass Index) below or equal to 35.0 kg/m^2
• FOR THE EXTENSION TRIAL, NN5401-3645:
• The subject must have completed the six-month treatment period in trial NN5401-3594

Exclusion criteria

• FOR THE MAIN TRIAL, NN5401-3594:
• Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
• Cardiovascular disease within the last 6 months
• Uncontrolled treated/untreated severe hypertension
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Cancer and medical history of cancer
• FOR THE EXTENSION TRIAL, NN5401-3645:
• Anticipated significant lifestyle changes during the trial
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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548 participants in 2 patient groups

IDegAsp OD

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec/insulin aspart

Drug: insulin aspart

IDet

Active Comparator group

Treatment:

Drug: insulin aspart

Drug: insulin detemir

Drug: insulin aspart