NCT01219400

Brief Summary

The purpose of this study is to explore whether the novel therapy of type 2 diabetes, vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment.

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 Jan 2012

Typical duration for phase_4 diabetes

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

October 12, 2010

Last Update Submit

September 29, 2014

Conditions

Diabetes

Keywords

DPP-4GLP-1GlucagonCatecholaminesCounterregulationInsulin-treatmentType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Glucagon response to hypoglycemia

    Change in glucagon from before hypoglycemia clamp until after 45 min

    45 min

Secondary Outcomes (1)

  • Catecholamine response to hypoglycemia

    45 min

Study Arms (1)

Vildagliptin

EXPERIMENTAL

Vildagliptin (50 mg BID) given for four weeks

Drug: Vildagliptin

Interventions

VildagliptinDRUG

Vildagliptin (50 mg BID) given for four weeks

Also known as: Galvus, 274901-16-5
Vildagliptin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Insulin treatment
  • Age \>18 years
  • HbA1c \<=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)

Lund University

Lund, 22184, Sweden

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bo Ahrén, MD, PhD

    Lund University

    STUDY CHAIR

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

October 12, 2010

First Posted

October 13, 2010

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

September 30, 2014

Record last verified: 2014-09

Locations

SE(1)