Vildagliptin and the Glucagon Response to Hypoglycemia in... | NCT01147276

Studies
Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

NCT01147276

Sponsor

Lund University

Status

Completed

Last Update Posted

Sep 25, 2012Estimated

Enrollment

28Actual

Phase

Phase 4

Conditions

Diabetes
Hypoglycemia

Interventions

Vildagliptin

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 17, 2010

First Submission Date that Met QC Criteria

Jun 17, 2010

First Posted Date

Jun 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2012

Last Update Posted Date

Sep 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vildagliptin	Experimental	Vildagliptin (50 mg BID) given for four weeks	Drug: Vildagliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin	Drug	Vildagliptin (50 mg BID) in four weeks	Vildagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucagon response to hypoglycemia	Change in glucagon from before hypoglycemic clamp until after 45 min	45 min

Secondary Outcomes

Measure	Description	Time Frame
Catecholamine response to hypoglycemic	Change in catecholamines from before hypolycemic clamp to 45 min	45 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
Lactation
Acute infection
Liver disease
Treatment with cortisol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bo Ahrén, PhD MD	Lund University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Sciences Lund, Lund University		Lund		221 84	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22855332	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D007003	Hypoglycemia
D003922	Diabetes Mellitus, Type 1

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring