Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01147276

Enrollment

Registered

2010-06-22

Start date

2010-09-30

Completion date

2011-12-31

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypoglycemia

Keywords

DPP-4, GLP-1, Glucagon, Catecholamines, Counterregulation, Type 1 diabetes

Brief summary

The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.

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.

Interventions

DRUGVildagliptin

Vildagliptin (50 mg BID) in four weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Type 1 diabetes * Age \>18 years * HbA1c 6.5-8,5%

Exclusion criteria

* Pregnancy * Lactation * Acute infection * Liver disease * Treatment with cortisol

Design outcomes

Primary

Measure	Time frame	Description
Glucagon response to hypoglycemia	45 min	Change in glucagon from before hypoglycemic clamp until after 45 min

Secondary

Measure	Time frame	Description
Catecholamine response to hypoglycemic	45 min	Change in catecholamines from before hypolycemic clamp to 45 min

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026