Dataset from 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

To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day
compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in
elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient
glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors
is also allowed.

In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when
added to background basal insulin therapy. The treatment duration of this trial (24 weeks)
will enable assessment of the clinically relevant endpoint of a decrease in glycosylated
Haemoglobin, a well-accepted measurement of chronic glycaemic control.