Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

Novo Nordisk A/S65 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 or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin degludecDRUG

The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime

insulin detemirDRUG

Injection subcutaneously at bedtime

insulin aspartDRUG

Injection subcutaneously immediately before each meal.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with type 1 diabetes mellitus more than one year * Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks) * HbA1c below 10.0% * Body Mass Index (BMI) below 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

Locations (8)

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, Japan

Novo Nordisk Investigational Site

Ebina-shi, Japan

Novo Nordisk Investigational Site

Koriyama-shi, Fukushima, Japan

Novo Nordisk Investigational Site

Kumamoto-shi,Kumamoto, Japan

Outcomes

Primary Outcomes

Rate of Major and Minor Hypoglycaemic Episodes

Observed 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

Observed 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 23:00-05:59 (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

Observed change from baseline in body weight after 6 weeks of treatment

Time frame: Week 0, Week 6

Electrocardiogram (ECG)

The number of subjects having a 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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