Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

Novo Nordisk A/S245 enrolled

Overview

This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

245

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin glargineDRUG

Treat-to-target dose titration scheme, s.c. injection.

insulin degludecDRUG

Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily

insulin degludecDRUG

Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) * Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months) * Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (SPC) or locally approved PI * HbA1c 7.0-11.0 % (both inclusive) * Body Mass Index (BMI) 23-42 kg/m\^2 \[lb/in\^2 x 703\] (both inclusive) Exclusion Criteria: * Metformin contraindication according to local practice * Thiazolidinedione (TZD) treatment within previous three months prior to visit 1 * Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation * Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial drug

Locations (29)

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 16 weeks of treatment

Time frame: Week 0, Week 16

Secondary Outcomes

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

Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.

Time frame: Week 16

Rate of Major and Minor Hypoglycaemic Episodes

Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.

Time frame: Week 0 to Week 16 + 5 days follow up

Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).

Time frame: Week 0 to Week 16 + 5 days follow up

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.

Data from ClinicalTrials.gov

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