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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00841087
First received: February 10, 2009
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin degludec
Drug: insulin detemir
Drug: insulin aspart
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Rate of Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 6 + 5 days follow up ] [ Designated as safety issue: No ]
  • Rate of Nocturnal Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 6 + 5 days follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 6 + 5 days follow up ] [ Designated as safety issue: No ]
  • Change in Body Weight [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
  • Diastolic Blood Pressure (BP) [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
  • Systolic Blood Pressure (BP) [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SIBA Drug: insulin degludec
The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime
Drug: insulin aspart
Injection subcutaneously immediately before each meal.
Active Comparator: Insulin Detemir Drug: insulin detemir
Injection subcutaneously at bedtime
Drug: insulin aspart
Injection subcutaneously immediately before each meal.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841087

Locations
Japan
Chuo-ku, Tokyo, Japan, 103 0002
Oita-shi, Japan, 870 0039
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michiaki Kanai Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00841087     History of Changes
Other Study ID Numbers: NN1250-3569, JapicCTI-090711
Study First Received: February 10, 2009
Last Updated: November 7, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin aspart
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014