Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
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 inadequ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT01880736
Start Date
June 1 2013
End Date
April 1 2014
Last Update
February 10 2017
Active Locations (40)
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1
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0002
2
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0027
3
Novo Nordisk Investigational Site
Fukui-shi, Fukui, Japan, 918-8503
4
Novo Nordisk Investigational Site
Fukuoka, Japan, 812 0025