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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:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00842361
First received: February 11, 2009
Last updated: December 15, 2016
Last verified: December 2016
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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 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 ]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 ]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 ]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 ]Change from baseline in body weight after 6 weeks of treatment
- Electrocardiogram (ECG) Worsening [ Time Frame: Week 0, Week 6 ]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 ]Values at baseline (Week 0) and at Week 6
- Systolic BP (Blood Pressure) [ Time Frame: Week 0, Week 6. ]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) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00842361
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842361
Locations
| Japan | |
| Novo Nordisk Investigational Site | |
| Chuo-ku, Tokyo, Japan, 103 0002 | |
| Novo Nordisk Investigational Site | |
| Miyazaki-shi, Japan, 880 0034 | |
| Novo Nordisk Investigational Site | |
| Naka-shi, Ibaraki, Japan, 311 0113 | |
| Novo Nordisk Investigational Site | |
| Ota-ku, Tokyo, Japan, 144 0035 | |
| Novo Nordisk Investigational Site | |
| Oyama-shi, Tochigi, Japan, 323 0022 | |
| Novo Nordisk Investigational Site | |
| Sendai-shi, Japan, 980 0021 | |
| Novo Nordisk Investigational Site | |
| Shizuoka-shi, Japan, 424 0853 | |
| Novo Nordisk Investigational Site | |
| Tagajo-shi, Japan, 985 0852 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk Pharma Ltd. |
More Information
Additional Information:
Publications:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00842361 History of Changes |
| Other Study ID Numbers: |
NN5401-3570 JapicCTI-090712 ( Registry Identifier: JAPIC ) |
| Study First Received: | February 11, 2009 |
| Results First Received: | October 19, 2015 |
| Last Updated: | December 15, 2016 |
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 Biphasic Insulins Insulin, Isophane Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 26, 2017