MedDataX Logo

Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

NCT ID: NCT01147276

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Hypoglycemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vildagliptin

Vildagliptin (50 mg BID) given for four weeks

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Vildagliptin (50 mg BID) in four weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vildagliptin

Vildagliptin (50 mg BID) in four weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Galvus

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* Lactation
* Acute infection
* Liver disease
* Treatment with cortisol
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lund University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bo Ahren

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bo Ahrén, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Clinical Sciences Lund, Lund University

Lund, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 22855332 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lund University Diabetes 002

Identifier Type: -

Identifier Source: org_study_id