Linagliptin and Insulin in elderly Type 2 Diabetes patients.
Research type
Research Study
Full title
A 24 week randomized, double-blind, placebo-controlled, parallel group, efficacy and safety trial of once daily linagliptin, 5 milligrams orally, as add on to basal insulin in elderly Type 2 Diabetes Mellitus patients with insufficient glycaemic control.
IRAS ID
156081
Contact name
Richard Falk
Contact email
Eudract number
2014-000904-88
Research summary
This is a 24 week randomized, double-blind, placebo-controlled, parallel group, efficacy and safety trial of once daily linagliptin, 5 milligrams orally, as add on to basal insulin in elderly Type 2 Diabetes Mellitus patients with insufficient glycaemic control. The study will be conducted at about 207 study clinics worldwide. About 1200 patients will be screened for suitability and about 800 patients will go on to receive study drug.
Patients will be required to attend 8 scheduled clinic visits over 28 weeks (7 months). Each visit will take 1-2.5 hours to complete depending on what has to be done and the last visit will take approximately 30 to 45 minutes. This study is divided into 4 parts:
• Screening Period (Visit 1): usually 1 week (but can be up to 2 weeks) to see if the patients qualify for the research study.
• Run-In Period (Visit 2): usually 1 week (but can be up to 2 weeks) in which patients will be given placebo study drug to take.
• Study Drug Treatment Period (Visits 3, 4, 5, 6, and 98): During this 24 week period, patients will take either linagliptin or placebo. Visits will be 6 weeks apart. At Visit 98, patients will stop taking the study drug.
• Post-Treatment Period (Visit 99): One week after the patient has stopped taking the study drug, they will return for a final study visit.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
14/EE/1082
Date of REC Opinion
3 Nov 2014
REC opinion
Further Information Favourable Opinion