Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
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| ClinicalTrials.gov Identifier: NCT00842361 |
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Recruitment Status :
Completed
First Posted : February 12, 2009
Results First Posted : November 20, 2015
Last Update Posted : February 9, 2017
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
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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/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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Diabetes Mellitus, Type 2 | Drug: insulin degludec/insulin aspart Drug: biphasic insulin aspart 30 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 66 participants |
| 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 SIAC Compared to Mix30 (NovoRapid®30Mix) on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | June 2009 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
| 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. |
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
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| 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
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): 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. |
Additional Information:
Publications of Results:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00842361 History of Changes |
| Other Study ID Numbers: |
NN5401-3570 JapicCTI-090712 ( Registry Identifier: JAPIC ) |
| First Posted: | February 12, 2009 Key Record Dates |
| Results First Posted: | November 20, 2015 |
| Last Update Posted: | February 9, 2017 |
| Last Verified: | December 2016 |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases 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 Insulin, Isophane Hypoglycemic Agents Physiological Effects of Drugs |