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

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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: Insulin Insulin human Insulin aspart Insulin detemir Insulin degludec

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Observed change from baseline in body weight after 6 weeks of treatment
Electrocardiogram (ECG) [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Mean values at baseline (Week 0) and at Week 6
Systolic Blood Pressure (BP) [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
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)
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

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site


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
Results First Received:	October 16, 2015
Last Updated:	October 16, 2015
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 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 29, 2016