Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk A/S
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
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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
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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
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 Autoimmune Diseases Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases |
Insulin Insulin Aspart Insulin, Globin Zinc Insulin, Long-Acting Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015