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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014