Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery (DARE)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Completed

Conditions

Hypoglycemia

Type 1 Diabetes

Treatments

Drug: Sitagliptin

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01272583

DARE_2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 Diabetes Mellitus 5-20 years duration
C-peptide negative
Willing and able to give written informed consent

Exclusion criteria

Impaired awareness of hypoglycaemia
BMI > 27 kg/m2
Evidence of severe diabetes complications (autonomic neuropathy, macroalbuminuria, proliferative retinopathy)
Acute illness within 3 months before the study
Significant renal impairment (creatinine clearance < 50ml/min)
Use of beta-adrenoreceptor blockers
Cardiac history (previous arrhythmia)
History of epilepsy