- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00842361
Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
December 15, 2016 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Chuo-ku, Tokyo, Japan, 103 0002
- Novo Nordisk Investigational Site
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Miyazaki-shi, Japan, 880 0034
- Novo Nordisk Investigational Site
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Naka-shi, Ibaraki, Japan, 311 0113
- Novo Nordisk Investigational Site
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Ota-ku, Tokyo, Japan, 144 0035
- Novo Nordisk Investigational Site
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Oyama-shi, Tochigi, Japan, 323 0022
- Novo Nordisk Investigational Site
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Sendai-shi, Japan, 980 0021
- Novo Nordisk Investigational Site
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Shizuoka-shi, Japan, 424 0853
- Novo Nordisk Investigational Site
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Tagajo-shi, Japan, 985 0852
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mix30
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The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.
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Experimental: SIAC
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The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Major and Minor Hypoglycaemic Episodes
Time Frame: Week 0 to Week 6 + 5 days follow up
|
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.
|
Week 0 to Week 6 + 5 days follow up
|
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Time Frame: Week 0 to Week 6 + 5 days follow up
|
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).
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Week 0 to Week 6 + 5 days follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Week 0 to Week 6 + 5 days follow up
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Change in Body Weight
Time Frame: Week 0, Week 6
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Change from baseline in body weight after 6 weeks of treatment
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Week 0, Week 6
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Electrocardiogram (ECG) Worsening
Time Frame: Week 0, Week 6
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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.
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Week 0, Week 6
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Diastolic BP (Blood Pressure)
Time Frame: Week 0, Week 6
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Values at baseline (Week 0) and at Week 6
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Week 0, Week 6
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Systolic BP (Blood Pressure)
Time Frame: Week 0, Week 6.
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Values at baseline (Week 0) and at Week 6
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Week 0, Week 6.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk Pharma Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
February 11, 2009
First Submitted That Met QC Criteria
February 11, 2009
First Posted (Estimate)
February 12, 2009
Study Record Updates
Last Update Posted (Estimate)
February 9, 2017
Last Update Submitted That Met QC Criteria
December 15, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Long-Acting
- Insulin degludec, insulin aspart drug combination
- Biphasic Insulins
- Insulin aspart, insulin aspart protamine drug combination 30:70
Other Study ID Numbers
- NN5401-3570
- JapicCTI-090712 (Registry Identifier: JAPIC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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