NCT01147276

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

1 year

First QC Date

June 17, 2010

Last Update Submit

September 21, 2012

Conditions

DiabetesHypoglycemia

Keywords

DPP-4GLP-1GlucagonCatecholaminesCounterregulationType 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Glucagon response to hypoglycemia

    Change in glucagon from before hypoglycemic clamp until after 45 min

    45 min

Secondary Outcomes (1)

  • Catecholamine response to hypoglycemic

    45 min

Study Arms (1)

Vildagliptin

EXPERIMENTAL

Vildagliptin (50 mg BID) given for four weeks

Drug: Vildagliptin

Interventions

VildagliptinDRUG

Vildagliptin (50 mg BID) in four weeks

Also known as: Galvus
Vildagliptin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Sciences Lund, Lund University

Lund, 221 84, Sweden

Location

Related Publications (1)

  • Farngren J, Persson M, Schweizer A, Foley JE, Ahren B. Vildagliptin reduces glucagon during hyperglycemia and sustains glucagon counterregulation during hypoglycemia in type 1 diabetes. J Clin Endocrinol Metab. 2012 Oct;97(10):3799-806. doi: 10.1210/jc.2012-2332. Epub 2012 Aug 1.

    PMID: 22855332DERIVED

MeSH Terms

Conditions

Diabetes MellitusHypoglycemiaDiabetes Mellitus, Type 1

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bo Ahrén, PhD MD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

SE(1)