Rilonacept in Diabetes Mellitus Type 1: Safety Study | NCT00962026

Studies
Rilonacept in Diabetes Mellitus Type 1: Safety Study

NCT00962026

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

Feb 24, 2014Estimated

Enrollment

13Actual

Phase

Phase 1

Conditions

Type 1 Diabetes Mellitus

Interventions

Rilonacept

Countries

United States

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

Feb 2014

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 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Aug 4, 2009

First Submission Date that Met QC Criteria

Aug 17, 2009

First Posted Date

Aug 19, 2009Estimated

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

Feb 21, 2014

Last Update Posted Date

Feb 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Perrin C White, Director of Pediatric Endocrinology, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Description Module

Brief Summary

This study is being done to see if an investigational drug called rilonacept is safe to use in patients with type 1 diabetes, and if it can slow the loss of the body's ability to secrete insulin in patients who are still able to make a small amount of insulin.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rilonacept	Experimental		Drug: Rilonacept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rilonacept	Drug	Rilonacept given subcutaneously, dose per package labeling, once weekly.	Rilonacept

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of infection in study participants		7 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence and severity of other adverse effects in study participants		7 months
Changes in participants' sex steroids (testosterone/estradiol)		7 months
Changes in participants' HbA1c levels, insulin doses, and beta cell preservation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Within 5 years of diagnosis of type 1 diabetes
Between the ages of 16 to 45 years
Have at least one diabetes-related autoantibody present
Have mean C-peptide level > 0.2 nmol/L on a mixed meal tolerance test
Be taking insulin
Complete written informed consent

Exclusion Criteria:

Taking inhaled or oral steroids (for example Advair, Orapred)
Have an active infection
Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
Have ongoing use of medications known to affect glucose tolerance
Have a live vaccine 90 days prior to, or during this study
Taking any other experimental medication within the past 28 days
Have prior treatment with rilonacept
Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
Pregnant or lactating females
Males and females unwilling to use an acceptable method of contraception for the duration of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Perrin C White, MD	University of Texas Southwestern Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Medical Center		Dallas	Texas	75235	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

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