Clinical trial NCT00841087: Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes
Official title: A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIBA Once Daily + NovoRapid® Compared to Insulin Detemir Once Daily + NovoRapid®, All in a Basal-bolus Regimen in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Major and Minor Hypoglycaemic Episodes
timeFrame: Week 0 to Week 6 + 5 days follow up
measure: Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
timeFrame: Week 0 to Week 6 + 5 days follow up
Secondary outcomes:
measure: Number of Treatment Emergent Adverse Events (AEs)
timeFrame: Week 0 to Week 6 + 5 days follow up
measure: Change in Body Weight
timeFrame: Week 0, Week 6
measure: Electrocardiogram (ECG)
timeFrame: Week 0, Week 6
measure: Diastolic Blood Pressure (BP)
timeFrame: Week 0, Week 6
measure: Systolic Blood Pressure (BP)
timeFrame: Week 0, Week 6
Other outcomes:
Locations:
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Ebina-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Koriyama-shi, Fukushima
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto-shi,Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Oita-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Iwamoto Y, Clauson P, Nishida T, Kaku K. Insulin degludec in Japanese patients with type 1 diabetes mellitus: A randomized controlled trial. J Diabetes Investig. 2013 Jan 29;4(1):62-8. doi: 10.1111/j.2040-1124.2012.00240.x. Epub 2012 Sep 14.