A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)

Novo Nordisk A/S1 site in 1 country833 target enrollmentJune 2, 2013

ConditionsDiabetes Diabetes Mellitus, Type 2

InterventionsInsulin Degludec Insulin Glargine

DrugsInsulin Degludec Insulin Glargine

Overview

Phase: Phase 3
Intervention: Insulin Degludec
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 833
Locations: 1
Primary Endpoint: Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2, 2013

End Date

May 15, 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Insulin Degludec

Intervention: Insulin Degludec

Insulin Glargine

Intervention: Insulin Glargine

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)

Time Frame: Week 0, week 26

Change from baseline in HbA1c (%) after 26 weeks of treatment.

Secondary Outcomes

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))
Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)(Week 0, week 26)
Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)(Week 26)
Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes(Week 26)
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))