A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin aspart

Drug: insulin degludec

Drug: insulin degludec/insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT01713530

U1111-1130-7135 (Other Identifier)

2012-002346-20 (EudraCT Number)

NN5401-3996

Details and patient eligibility

About

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

Enrollment

274 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
HbA1c 7.0% - 10.0%
Body mass index (BMI) less than or equal to 40.0 kg/m^2

Exclusion criteria

Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Chronic disorder or disease which might jeopardise safety or compliance
Malignant neoplasms
Recurrent severe hypoglycaemia