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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
insulin degludec
insulin detemir
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SIBA

Insulin Detemir

Arm Description

Outcomes

Primary Outcome Measures

Rate of Major and Minor Hypoglycaemic Episodes
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
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)
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
Observed change from baseline in body weight after 6 weeks of treatment
Electrocardiogram (ECG)
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)
Mean values at baseline (Week 0) and at Week 6
Systolic Blood Pressure (BP)
Mean values at baseline (Week 0) and at Week 6

Full Information

First Posted
February 10, 2009
Last Updated
January 19, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00841087
Brief Title
Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIBA
Arm Type
Experimental
Arm Title
Insulin Detemir
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Injection subcutaneously at bedtime
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Injection subcutaneously immediately before each meal.
Primary Outcome Measure Information:
Title
Rate of Major and Minor Hypoglycaemic Episodes
Description
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.
Time Frame
Week 0 to Week 6 + 5 days follow up
Title
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Description
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).
Time Frame
Week 0 to Week 6 + 5 days follow up
Secondary Outcome Measure Information:
Title
Number of Treatment Emergent Adverse Events (AEs)
Description
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.
Time Frame
Week 0 to Week 6 + 5 days follow up
Title
Change in Body Weight
Description
Observed change from baseline in body weight after 6 weeks of treatment
Time Frame
Week 0, Week 6
Title
Electrocardiogram (ECG)
Description
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.
Time Frame
Week 0, Week 6
Title
Diastolic Blood Pressure (BP)
Description
Mean values at baseline (Week 0) and at Week 6
Time Frame
Week 0, Week 6
Title
Systolic Blood Pressure (BP)
Description
Mean values at baseline (Week 0) and at Week 6
Time Frame
Week 0, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
103 0002
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ebina-shi
ZIP/Postal Code
243 0432
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Koriyama-shi, Fukushima
ZIP/Postal Code
963 8851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kumamoto-shi,Kumamoto
ZIP/Postal Code
862 0976
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Oita-shi
ZIP/Postal Code
870 0039
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060 0062
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
062 0007
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Yokohama-shi
ZIP/Postal Code
235 0045
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24843632
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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