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

Novo Nordisk A/S66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin degludec/insulin aspartDRUG

The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.

biphasic insulin aspart 30DRUG

The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (8)

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, Japan

Novo Nordisk Investigational Site

Miyazaki, Japan

Novo Nordisk Investigational Site

Naka-shi, Ibaraki, Japan

Novo Nordisk Investigational Site

Ota-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Rate of Major and Minor Hypoglycaemic Episodes

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.

Time frame: Week 0 to Week 6 + 5 days follow up

Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

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).

Time frame: Week 0 to Week 6 + 5 days follow up

Secondary Outcomes

Number of Treatment Emergent Adverse Events (AEs)

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.

Time frame: Week 0 to Week 6 + 5 days follow up

Change in Body Weight

Change from baseline in body weight after 6 weeks of treatment

Time frame: Week 0, Week 6

Electrocardiogram (ECG) Worsening

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.

Data from ClinicalTrials.gov

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