Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes

Novo Nordisk A/S296 enrolled

Overview

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

296

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin degludec/insulin aspartDRUG

Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).

insulin glargineDRUG

Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis * Body Mass Index (BMI) below or equal to 35.0 kg/m\^2 * Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days) Exclusion Criteria: * Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors * Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation * Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty

Locations (50)

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Observed change from baseline in HbA1c after 26 weeks of treatment

Time frame: Week 0, Week 26

Secondary Outcomes

Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal

Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal

Time frame: Week 26

Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. 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 26 + 7 days follow up

Rate of Confirmed Hypoglycaemic Episodes

Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

Time frame: Week 0 to Week 26 + 7 days follow up

Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Data from ClinicalTrials.gov

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