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CompletedNCT01147276Updated Sep 25, 2012

Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

A Phase 4 interventional study of Vildagliptin in Diabetes and Hypoglycemia, sponsored by Lund University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-09-25.

Sponsored by Lund University · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Diabetes
  • Hypoglycemia

Keywords

  • DPP-4
  • GLP-1
  • Glucagon
  • Catecholamines
  • Counterregulation
  • Type 1 diabetes
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 28 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Acute infection
  • Liver disease
  • Treatment with cortisol
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Vildagliptin

    Vildagliptin (50 mg BID) given for four weeks

    Drug: Vildagliptin

Interventions

  • DrugVildagliptin

    Vildagliptin (50 mg BID) in four weeks

    Also known as: Galvus

06

What researchers measure

Primary outcomes

  1. Glucagon response to hypoglycemia

    Change in glucagon from before hypoglycemic clamp until after 45 min

    Time frame: 45 min

Secondary outcomes

  1. Catecholamine response to hypoglycemic

    Change in catecholamines from before hypolycemic clamp to 45 min

    Time frame: 45 min

07

Study locations

1 site
  • Department of Clinical Sciences Lund, Lund University
    Lund, 221 84, Sweden
08

References and documents

Publications

  • 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. PubMed 22855332 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01147276
Lead sponsor
Lund University
Responsible party
Bo Ahren (Professor, Lund University) — Principal investigator
First posted
Jun 22, 2010
Start date
Sep 2010
Primary completion
Sep 2011
Completion
Dec 2011
Last update
Sep 25, 2012

Study contacts

Bo Ahrén, PhD MD
principal investigator · Lund University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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