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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes; Diabetes Mellitus, Type 1	Drug: insulin degludec; Drug: insulin detemir; Drug: insulin aspart	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	65 participants
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
Study Start Date :	January 2009
Actual Primary Completion Date :	May 2009
Actual Study Completion Date :	May 2009

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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 :

1. 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.
2. Change in Body Weight [ Time Frame: Week 0, Week 6 ]
   Observed change from baseline in body weight after 6 weeks of treatment
3. 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.
4. Diastolic Blood Pressure (BP) [ Time Frame: Week 0, Week 6 ]
   Mean values at baseline (Week 0) and at Week 6
5. Systolic Blood Pressure (BP) [ Time Frame: Week 0, Week 6 ]
   Mean values at baseline (Week 0) and at Week 6

Eligibility Criteria

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Clinical Trials at Novo Nordisk 

Publications of Results:

Iwamoto Y, Clauson P, Nishida T, Kaku K. Insulin degludec in Japanese patients with type 1 diabetes mellitus: A randomized controlled trial. J Diabetes Investig. 2013 Jan 29;4(1):62-8. doi: 10.1111/j.2040-1124.2012.00240.x. Epub 2012 Sep 14.

Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00841087 History of Changes
Other Study ID Numbers:	NN1250-3569; JapicCTI-090711 ( Registry Identifier: JAPIC )
First Posted:	February 11, 2009
Results First Posted:	November 16, 2015
Last Update Posted:	March 3, 2017
Last Verified:	January 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