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

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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)

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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