Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery

NCT01272583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-03-14

Study results available
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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.

Conditions

Interventions

DRUG

Sitagliptin

100 mg once daily for six weeks

DRUG

Placebo

placebo, once daily for six weeks

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Frits Holleman, MD,PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2012-10-31

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01272583 on ClinicalTrials.gov