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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:
ClinicalTrials.gov Identifier:
NCT00841087
First Posted: February 11, 2009
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Submitted: February 10, 2009
First Posted: February 11, 2009
Results First Submitted: October 16, 2015
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