Incretin Effect on the Immunological Phenotype | NCT01782261

Studies
Incretin Effect on the Immunological Phenotype

NCT01782261

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Oct 11, 2016Estimated

Enrollment

15Actual

Phase

Phase 2

Conditions

Type 1 Diabetes

Interventions

Liraglutide
Saxagliptin

Countries

Austria

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

ID	Type	Description	Link
2011-006300-12	EudraCT Number

Status Module

Record Verification Date

Oct 2016

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

Feb 2012

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jan 30, 2013

First Submission Date that Met QC Criteria

Jan 30, 2013

First Posted Date

Feb 1, 2013Estimated

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

Oct 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

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

Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes

Detailed Description

Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liraglutide	Experimental	Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg.	Drug: Liraglutide
Saxagliptin	Active Comparator	Saxagliptin 5mg tablet by mouth every day for 4 weeks	Drug: Saxagliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liraglutide	Drug	once daily subcutaneous injection	Liraglutide	Victoza

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase of regulatory FOXP3+ T cells	the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Immunophenotyping	The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-healthy subjects or patients with type 1 diabetes

Exclusion Criteria:

pregnancy
treatment with GLP-1-Analoga (Liraglutide, Exenatide)
treatment with DPP4-inhibitor (Sitagliptin, Vildagliptin, Saxagliptin)
chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas R Pieber, Professor	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Graz		Graz		8036	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D001327	Autoimmune Diseases

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069450	Liraglutide
C502994	saxagliptin

Ancestor Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

Browse Leaves

Not provided

Browse Branches

Not provided