Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1; Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841087

NN1250-3569

JapicCTI-090711 (Registry Identifier)

Details and patient eligibility

About

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

Enrollment: 65 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with type 1 diabetes mellitus more than one year
• Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks)
• HbA1c below 10.0%
• Body Mass Index (BMI) below 30.0 kg/m^2

Exclusion criteria

• Known hypoglycaemia unawareness or recurrent major hypoglycaemia
• Current treatment with total insulin dose of more than 100 U or IU/day
• Current treatment or expected to start treatment with systemic corticosteroid

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

SIBA

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec

Insulin Detemir

Active Comparator group

Treatment:

Drug: insulin detemir

Drug: insulin aspart