A Pan Asian Trial Comparing Efficacy and Safety of Insulin NN1250 and Insulin Glargine as Add on to OAD(s) in Subjects With Type 2 Diabetes (BEGIN™: ONCE ASIA)

Novo Nordisk A/S1 site in 1 country435 target enrollmentFebruary 1, 2010

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: 435
Locations: 1
Primary Endpoint: Change in Glycosylated Haemoglobin (HbA1c)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes never treated with insulin.

Registry

clinicaltrials.gov

Start Date

February 1, 2010

End Date

December 16, 2010

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

•For Japan only: minimum age is 20 years
•Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
•Current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a DPP-4 inhibitor with unchanged dosing for at least 3 months prior to visit
•The dose(s) should as minimum be as stated: -Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to local labelling -Metformin: alone or in combination (including fixed combination): Maximum tolerated dose - alfa-glucosidase-inhibitors: Minimum half of the daily maximal dose or maximum tolerated dose -DPP-4 (dipeptyl peptidase 4) inhibitor: According to local labelling
•HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
•Body Mass Index (BMI) no higher than 35.0 kg/m\^2

Exclusion Criteria

•Use within the last 3 months prior to Visit 1 of: TZDs (thiazolidinediones), exenatide or liraglutide
•Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
•Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
•Pregnancy, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)
•Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Arms & Interventions

IDeg OD

Intervention: insulin degludec

IGlar OD

Intervention: insulin glargine

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Time Frame: Week 0, Week 26

Change from baseline in HbA1c after 26 weeks of treatment

Secondary Outcomes

Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)(Week 26)