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

Study Description

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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 Design

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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

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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 :

1. 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.
2. Change in Body Weight [ Time Frame: Week 0, Week 6 ]
   Change from baseline in body weight after 6 weeks of treatment
3. 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.
4. Diastolic BP (Blood Pressure) [ Time Frame: Week 0, Week 6 ]
   Values at baseline (Week 0) and at Week 6
5. Systolic BP (Blood Pressure) [ Time Frame: Week 0, Week 6. ]
   Values at baseline (Week 0) and at Week 6

Eligibility Criteria

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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 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Clinical Trials at Novo Nordisk 

Publications of Results:

Onishi Y, Yamada K, Zacho J, Ekelund J, Iwamoto Y. Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial. J Diabetes Investig. 2017 Mar;8(2):210-217. doi: 10.1111/jdi.12569. Epub 2016 Oct 7.

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
Results First Posted:	November 20, 2015
Last Update Posted:	February 9, 2017
Last Verified:	December 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