A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

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

NCT01880736

U1111-1137-0953 (Other Identifier)

JapicCTI- 132164 (Other Identifier)

NN1250-4060

Details and patient eligibility

About

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.

Enrollment: 458 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
• Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit)
• HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis
• Body mass index (BMI) equal to or below 35 kg/m^2

Exclusion criteria

• Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
• 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; all within the last 26 weeks prior to Visit 1 (Screening visit)
• Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females
• Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
• Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

458 participants in 4 patient groups

IDeg OD Flexible Dose

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

IDeg OD Fixed Dose

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

IDeg OD Simple

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

IDeg OD Stepwise

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec