A Study to Evaluate Symlin in Adolescent Subjects With Ty... | NCT00313183

Studies
A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus

NCT00313183

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 6, 2015Estimated

Enrollment

12Actual

Phase

Phase 2

Conditions

Type 1 Diabetes Mellitus

Interventions

pramlintide acetate

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

Jan 2015

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

Apr 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Apr 10, 2006

First Submission Date that Met QC Criteria

Apr 10, 2006

First Posted Date

Apr 12, 2006Estimated

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

Mar 5, 2015

Last Update Posted Date

Mar 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these subjects.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects	Drug: pramlintide acetate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pramlintide acetate	Drug	single subcutaneous doses of 15mcg and 30mcg	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes		single doses
To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes		single doses

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints		single doses

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening
Be on a stable regimen requiring multiple daily injections of basal and mealtime insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to screening
HbA1c between 6.0% and 10.0%, inclusive, at screening
Body weight >=50 kg at screening

Exclusion Criteria:

Currently being treated with the following medications: *Any oral antihyperglycemic agent; *Drugs that directly affect gastrointestinal motility
Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
Has received any investigational drug within 1 month of screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lisa Porter, MD	Amylin Pharmaceuticals, LLC.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aurora	Colorado		United States
Research Site

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

Intervention Browse Module

MeSH Terms

ID	Term
C105254	pramlintide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided