Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00842361
First received: February 11, 2009
Last updated: November 20, 2015
Last verified: November 2015
  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/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec/insulin aspart
Drug: biphasic insulin aspart 30
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 SIAC Compared to Mix30 (NovoRapid®30Mix) on a Twice Daily Regimen in Subjects With Type 2 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 ] [ Designated as safety issue: No ]
    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 ]
    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 and 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 ]
    Change from baseline in body weight after 6 weeks of treatment

  • Electrocardiogram (ECG) Worsening [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
    The number of subjects having an 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 BP (Blood Pressure) [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
    Values at baseline (Week 0) and at Week 6

  • Systolic BP (Blood Pressure) [ Time Frame: Week 0, Week 6. ] [ Designated as safety issue: No ]
    Values at baseline (Week 0) and at Week 6


Enrollment: 66
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mix30 Drug: biphasic insulin aspart 30
The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.
Experimental: SIAC Drug: insulin degludec/insulin aspart
The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.

  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 2 diabetes mellitus
  • Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
  • HbA1c below 10.0%
  • Body Mass Index (BMI) < 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
  • Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer [thiazolidinedione: TZD]) within the last 12 weeks prior to screening
  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: NCT00842361

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 Pharma Ltd.
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00842361     History of Changes
Other Study ID Numbers: NN5401-3570  JapicCTI-090712 
Study First Received: February 11, 2009
Results First Received: October 19, 2015
Last Updated: November 20, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin, Isophane
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2016