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
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.
Inclusion criteria:
Exclusion criteria:
Jacksonville, Florida 32204, United States
East Ringwood, Victoria 3135, Australia
Aichi, Nagoya, 462-0825, Japan
Ibaraki, Koga, 306-0232, Japan
Ibaraki, Naka, 311-0113, Japan
Kanagawa, Kamakura, 247-0056, Japan
Kanagawa, Sagamihara, 252-0302, Japan
Kanagawa, Yokohama, 221-0802, Japan
Kanagawa, Yokohama, 241-0821, Japan
Kanagawa, Yokohama, 245-8575, Japan
Okayama, Okayama, 700-8511, Japan
Osaka, Osaka, 530-0001, Japan
Osaka, Osaka, 550-0012, Japan
Osaka, Suita, 565-0853, Japan
Saga, Saga, 849-0917, Japan
Saitama, Kawagoe, 350-0851, Japan
Shizuoka, Hamamatsu, 430-8525, Japan
Tokyo, Chuo-ku, 103-0002, Japan
Tokyo, Chuo-ku, 103-0027, Japan
Tokyo, Chuo-ku, 103-0028, Japan
Tokyo, Chuo-ku, 104-0061, Japan
Tokyo, Koto-ku, 135-0011, Japan
Tokyo, Kunitachi, 186-0002, Japan