Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate

Criteria

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