Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes
Information source: Lund University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Hypoglycemia
Intervention: Vildagliptin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Lund University Official(s) and/or principal investigator(s):
Bo Ahrén, PhD MD, Principal Investigator, Affiliation: Lund University
Summary
The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon
counterregulatory response to hypoglycemia in type 1 diabetes.
Clinical Details
Official title: Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Glucagon response to hypoglycemia
Secondary outcome: Catecholamine response to hypoglycemic
Detailed description:
Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks
in patients with type 1 diabetes. Then, a hypoglycemic clamp (2. 5 mmol/l glucose) is
undertaken with the determination of glucagon.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 1 diabetes
- Age >18 years
- HbA1c 6. 5-8,5%
Exclusion Criteria:
- Pregnancy
- Lactation
- Acute infection
- Liver disease
- Treatment with cortisol
Locations and Contacts
Department of Clinical Sciences Lund, Lund University, Lund 221 84, Sweden
Additional Information
Starting date: September 2010
Last updated: September 21, 2012
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