A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: Insulin Degludec
Drug: Insulin Glargine

Registration Number: NCT01849289

Lead Sponsor: Novo Nordisk A/S

Brief Summary: This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 833

Inclusion Criteria

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
BMI (Body Mass Index) below or equal to 40.0 kg/m^2

Exclusion Criteria

Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening)
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors
Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the results of the trial
Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
Known or suspected hypersensitivity to trial product(s) or related products

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Degludec	Insulin Degludec	-
Insulin Glargine	Insulin Glargine	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)	Week 0, week 26	Change from baseline in HbA1c (%) after 26 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes	On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)	Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose \< 2.8 mmol/L (50 mg/dL), or PG \< 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value \< 2.8 mmol/L (50 mg/dL) or PG value \< 3.1 mmol/L (56 mg/dL).
Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)	Week 0, week 26	Change from baseline in FPG after 26 weeks of treatment.
Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)	Week 26	Within subject Coefficient of variation(CV\[%\]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.
Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes	Week 26	A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.
Number of Treatment Emergent AEs (Adverse Events)	On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)	Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)