Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

Novo Nordisk A/S530 enrolled

Overview

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug). The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

530

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin degludec/insulin aspartDRUG

Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.

insulin glargineDRUG

Injected s.c. (under the skin) once daily. Dose was individually adjusted.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * For MAIN period (NN5401-3590): * Diagnosis of type 2 diabetes mellitus for at least 6 months * Insulin naïve subjects * Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start * Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive) * Body Mass Index (BMI) no higher than 40.0 kg/m\^2 * For EXTENSION period (NN5401-3726): * Informed consent obtained before any trial-related activities * Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590 Exclusion Criteria: * For MAIN period (NN5401-3590): * Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start * Cardiovascular disease diagnosed within 6 months before trial start * For EXTENSION period (NN5401-3726): * Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors * Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician) * Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements

Locations (92)

Outcomes

Primary Outcomes

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment.

Time frame: Week 0, Week 26

Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

Time frame: Week 0 to Week 53 + 7 days follow up

Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Time frame: Week 0 to Week 53 + 7 days follow up

Extension Trial (Primary Endpoint): 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 the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the 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 hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect

Data from ClinicalTrials.gov

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