A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes

Novo Nordisk A/S424 enrolled

Overview

This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

424

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin degludec/insulin aspartDRUG

Injected subcutaneously twice daily. Dose was individually adjusted.

biphasic insulin aspart 30DRUG

Injected subcutaneously twice daily. Dose was individually adjusted.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female at least 18 years of age (at least 20 years for Japan) * Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, OD or BID, with or without metformin, for at least 3 months * HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis * Body mass index (BMI) maximum 35.0 kg/m\^2 Exclusion Criteria: * Treatment with oral antidiabetic drugs (OADs) (except metformin) within the last 8 weeks prior to Visit 1 * Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 3 months prior to Visit 1 * 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 * Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg) * Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Locations (46)

Outcomes

Primary Outcomes

Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment.

Time frame: Week 0, Week 26

Secondary Outcomes

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.

Time frame: Week 26

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.

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

Rate of Nocturnal Confirmed Hypoglycaemic Episodes

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

Change in Body Weight

Change from baseline in body weight after 26 weeks of treatment.

Data from ClinicalTrials.gov

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