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Completed

NCT Number: NCT01147276

Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

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

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Clinical Sciences Lund, Lund University

Lund, 221 84, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Vildagliptin

Drug

Vildagliptin (50 mg BID) in four weeks

Other names: Galvus

Primary outcomes

  1. Glucagon response to hypoglycemia

    Time frame: 45 min

    Change in glucagon from before hypoglycemic clamp until after 45 min

Secondary outcomes

  1. Catecholamine response to hypoglycemic

    Time frame: 45 min

    Change in catecholamines from before hypolycemic clamp to 45 min

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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