ACZ885 in Type 1 Diabetes Mellitus | NCT01322321

Studies
ACZ885 in Type 1 Diabetes Mellitus

NCT01322321

Sponsor

Novartis Pharmaceuticals

Status

Withdrawn

Last Update Posted

Sep 5, 2012Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Diabetes Mellitus
Diabetes Type 1

Interventions

ACZ885
Placebo

Countries

United States
Canada
Germany
United Kingdom

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
2010-020166-20	EudraCT Number

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jun 2011Estimated

Completion Date

Not provided

First Submitted Date

Mar 22, 2011

First Submission Date that Met QC Criteria

Mar 23, 2011

First Posted Date

Mar 24, 2011Estimated

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 4, 2012

Last Update Posted Date

Sep 5, 2012Estimated

Description Module

Brief Summary

This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.

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

0Actual

Label	Type	Description	Intervention Names
ACZ885	Experimental		Drug: ACZ885
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ACZ885	Drug		ACZ885
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months		at 13 months

Secondary Outcomes

Measure	Description	Time Frame
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 4, 7, 10, 18, 24, 30 and 36 months		36 months
Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months		36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen
presence of at least one diabetes-related autoantibody
qualifying C-peptide value in a mixed meal test at visit 1
willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug
body weight of at least 30 kg

Exclusion Criteria:

women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc)
immunodeficiency
active infections or febrile illness within 3 days before visit 1
major dental work within 8 days before visit 1
positive test for tuberculosis at visit 1
use of medications other than insulin for the treatment of diabetes Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aurora St Luke's Medical Center, Endocrine & Diabetes Center		Milwaukee	Wisconsin		United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C541220	canakinumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided