Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: insulin degludec
Drug: insulin glargine

Registration Number: NCT00982644

Lead Sponsor: Novo Nordisk A/S

Brief Summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1030

Inclusion Criteria

Type 2 diabetes mellitus
Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
HbA1c: 7.0-10.0%
Body Mass Index (BMI) no higher than 40.0 kg/m^2
For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)

Exclusion Criteria

Treatment with exenatide or liraglutide within the last 3 months before trial start
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Cancer and medical history of cancer

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDeg OD	insulin degludec	-
IGlar OD	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes	Week 0 to Week 104 + 7 days follow up	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. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment	Week 0, Week 52	Change from baseline in HbA1c after 52 weeks of treatment
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes	Week 0 to Week 104 + 7 days follow up	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.
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)	Week 0 to Week 104 + 7 days of follow up	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.

Secondary Outcome Measures

Name	Time	Method
Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes	Week 0 to Week 52 + 7 days follow up	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.
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment	Week 0, Week 104	Change from baseline in HbA1c after 104 weeks of treatment
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52	Week 52	Mean of 9-point SMPG at 52 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.
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104	Week 104	Mean of 9-point SMPG at 104 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.
Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes	Week 0 to Week 52 + 7 days follow up	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. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.