Conditions: Diabetes Mellitus Type 2
Keywords: vildagliptin sitagliptin continuous glucose monitoring (CGM) glycemic fluctuations MAGE impact of hypoglycemia on heart function (cardiac dysfuction measured via ECG) difference in glycemic profile of vildagliptin compared to sitagliptin
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 51
Healthy volunteers: no

Brief summary:
Vildagliptin and Sitagliptin both belong to the class of DPP-4 inhibitors, but differ in their pharmacokinetic profile as well as in their approved application (Vildagliptin, 2x 50 mg daily, Sitagliptin, 1x 100 mg daily). This leads to distinct results regarding postprandial blood-glucose normalization as well as protective properties regarding hypoglycemic episodes - especially during the night. Additionally, in type 1 diabetic patients a correlation has been described between hypoglycemia and abnormal heart function (QTc-elongation), which can have severe consequences for the patients. This study aims for the evaluation of the potency of both drugs to prevent and/or reduce hypoglycemic events in insulin-dependent type-2 diabetics and furthermore to evaluate the correlation of hypoglycemic episodes with changes in heart-function measured by Holter-ECG.

The hypothesis is tested, if vildagliptin leads to a more favourable glycemic profile than sitagliptin and is more potent in protecting from nocturnal abnormalities in heart-function caused by undetected hypoglycemic episodes.

Detailed description:

Arms:
arm 1: Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks arm 2: Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks

Interventions: intervention 1: Vildagliptin intervention 2: Sitagliptin
Intervention descriptions: intervention 1: vildagliptin 50mg BID for 8 weeks intervention 2: sitagliptin 100mg QD for 8 weeks

Protocol document: