Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus (BEGIN™)

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin degludec

Study type

Interventional

Funder types

Industry

Identifiers

NCT01364428

U1111-1119-2518 (Registry Identifier)

NN1250-3923

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.

Enrollment

373 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
Body mass index (BMI) below or equal to 45 kg/m^2
Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol

Exclusion criteria

Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
Known or suspected hypersensitivity to trial products or related products
The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)