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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: January 19, 2017
Last verified: January 2017
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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 Intervention Model: Parallel Assignment Masking: None (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:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
U.S. FDA Resources
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 ]Observed rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.
- Rate of Nocturnal Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 6 + 5 days follow up ]Observed rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00−05:59 (both inclusive).
Secondary Outcome Measures:
- Number of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 6 + 5 days follow up ]Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
- Change in Body Weight [ Time Frame: Week 0, Week 6 ]Observed change from baseline in body weight after 6 weeks of treatment
- Electrocardiogram (ECG) [ Time Frame: Week 0, Week 6 ]The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.
- Diastolic Blood Pressure (BP) [ Time Frame: Week 0, Week 6 ]Mean values at baseline (Week 0) and at Week 6
- Systolic Blood Pressure (BP) [ Time Frame: Week 0, Week 6 ]Mean values at baseline (Week 0) and at Week 6
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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 | |
| Novo Nordisk Investigational Site | |
| Chuo-ku, Tokyo, Japan, 103 0002 | |
| Novo Nordisk Investigational Site | |
| Ebina-shi, Japan, 243 0432 | |
| Novo Nordisk Investigational Site | |
| Koriyama-shi, Fukushima, Japan, 963 8851 | |
| Novo Nordisk Investigational Site | |
| Kumamoto-shi,Kumamoto, Japan, 862 0976 | |
| Novo Nordisk Investigational Site | |
| Oita-shi, Japan, 870 0039 | |
| Novo Nordisk Investigational Site | |
| Sapporo-shi, Hokkaido, Japan, 060 0062 | |
| Novo Nordisk Investigational Site | |
| Sapporo-shi, Hokkaido, Japan, 062 0007 | |
| Novo Nordisk Investigational Site | |
| Yokohama-shi, Japan, 235 0045 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
Publications:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00841087 History of Changes |
| Other Study ID Numbers: |
NN1250-3569 JapicCTI-090711 ( Registry Identifier: JAPIC ) |
| Study First Received: | February 10, 2009 |
| Results First Received: | October 16, 2015 |
| Last Updated: | January 19, 2017 |
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 degludec, insulin aspart drug combination Insulin Insulin Aspart Insulin, Long-Acting Insulin Detemir Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 21, 2017