Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes

Novo Nordisk A/S687 enrolled

Overview

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

687

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin degludecDRUG

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

insulin degludecDRUG

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

insulin glargineDRUG

Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1 * HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis * Body Mass Index (BMI) below or equal to 40.0 kg/m\^2 Exclusion Criteria: * Cancer and medical history of cancer hereof * Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors * 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 hereof (except basal cell skin cancer and squamous cell skin cancer)

Locations (72)

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

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)

Mean of SMPG after 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, before 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/L.

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

Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Rate of nocturnal 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. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.

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

Data from ClinicalTrials.gov

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