Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 42
Healthy volunteers: no

Brief summary:
The general aim of the present study is to investigate the impact of 4 weeks treatment with linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the current trial this effect of linagliptin treatment on endothelial function will be compared against both the sulfonylurea glimepiride and against placebo, which has not been tested in a trial before; as also is the case for other DPP-4 inhibitors.

Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second most used oral antidiabetic drug class.

Detailed description:

Arms:
arm 1: given once daily over 28 days arm 2: given once daily in 1mg dosis over 7 days, following a titration step to 2mg and application for 21 days arm 3: given once daily over 28 days

Interventions: intervention 1: Placebo intervention 2: Linagliptin intervention 3: Placebo intervention 4: Placebo intervention 5: Placebo intervention 6: Glimepiride
Intervention descriptions: intervention 1: Placebo matching Glimepiride intervention 2: given once daily for 28 days intervention 3: Placebo matching Linagliptin intervention 4: Placebo matching Linagliptin intervention 5: Placebo matching Glimepiride intervention 6: 1 mg for 7 days followed by uptitration to 2 mg (given for following 21 days)

Protocol document: