Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S222 enrolled

Overview

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

222

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin degludecDRUG

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

insulin degludecDRUG

Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2) * Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily * HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis * BMI (Body Mass Index) no higher than 45.0 kg/m\^2 Exclusion Criteria: * Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2 * Suffer from a life threatening disease (e.g. cancer) * Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise \[for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner\])

Locations (45)

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

Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 26 weeks of treatment.

Time frame: Week 0, 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 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

Observed 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.

Data from ClinicalTrials.gov

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