Conditions: Type 1 Diabetes Hypoglycemia
Keywords: Type 1 diabetes DPP-4 inhibitor Glucagon
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: no

Brief summary:
Hypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory response to hypoglycaemia, with glucagon as the most important mediator, is initially diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors augment the glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The investigators hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will recover the alpha cell response to hypoglycaemia.

Detailed description:
The 16 type 1 patients will be randomised to one of two treatment sequences: DPP-4 inhibitor followed by placebo or placebo followed by a DPP-4 inhibitor. Each treatment period lasts 6 weeks, so all patients will receive treatment for 12 weeks in total. Induction of hypoglycaemia will take place at 0 weeks, 6 weeks and 12 weeks to determine the glucagon response.

Arms:
arm 1: Cross-over, both arms reveived the same intervention in different order. arm 2: Cross-over, both arms reveived the same intervention in different order.

Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg once daily for six weeks intervention 2: placebo, once daily for six weeks

Protocol document: