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A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT

Primary Purpose

Type 1 Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
rhGAD65
rhGAD65
Placebo
Sponsored by
Diamyd Therapeutics AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, Diamyd, rhGAD65, GAD, GAD-alum

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
  • Fasting C-peptide level at time of screening above 0.1 nmol/L
  • Elevated GAD65 antibodies (GADA) at time of screening
  • Male and female patients between 10 and 20 years of age

Main Exclusion Criteria:

  • Treatment with immunosuppressants or any anti-diabetic medications other than insulin
  • A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
  • Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
  • Participation in other clinical trials with a new chemical entity within the previous 3 months
  • Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
  • Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study

Sites / Locations

  • University of Arizona
  • Arkansas Children's Hospital Research Institute
  • Alex Endocrine Associates
  • Children's Hospital Orange County
  • Rady Children's Hospital
  • Stanford University Medical Center
  • Barbara Davis Center for Childhood Diabetes
  • Christina Care Research institute
  • University of Florida
  • Nemours Children's Clinic
  • Miami Children's Hospital Research Institute
  • University of South Florida
  • Atlanta Diabetes Associates
  • Rocky Mountain Diabetes and Osteoporosis Center
  • University of Iowa Hospitals and Clinicals
  • Mid America Diabetes Associates
  • University of Kentucky College of Medicine
  • University of Louisville Research Foundation
  • Children's Hospital
  • University of Maryland Medical Center
  • Tufts Medical Center
  • UMass Memorial Medical Center
  • University of Michigan Health System
  • Alzohaili Medical Consultants
  • The Children's Mercy Hospital
  • St. Louis Children's Hospital
  • Creighton Diabetes Center
  • Kathryn Eckert
  • Hackensack University Medical Center
  • Morristown Memorial Hospital
  • Winthrop University Hospital
  • Naomi Berrie Diabetes Center of Columbia University
  • University of Rochester
  • SUNY Institute for Human Performance
  • Children's Hospital Medical Center of Akron
  • University of Oklahoma, Schustermann Center Clinic
  • Children's Hospital of Pittsburgh of UPMC
  • Regional Medical Clinic - Endocrinology
  • LeBonheur Children's Medical Center
  • Cook Children's Medical Center
  • CHRISTUS Santa Rosa Children's Hospital
  • Virginia Commonwealth University
  • Benaroya Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

A

B

C

Arm Description

This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on days 90 and 270.

This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on days 90 and 270.

This arm will receive 4 injections of placebo, 1 each on days 1, 30, 90 and 270.

Outcomes

Primary Outcome Measures

Meal Stimulated C-peptide (area under the curve)

Secondary Outcome Measures

HbA1c
Insulin Dose

Full Information

First Posted
September 11, 2008
Last Updated
October 9, 2012
Sponsor
Diamyd Therapeutics AB
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1. Study Identification

Unique Protocol Identification Number
NCT00751842
Brief Title
A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT
Official Title
A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (USA)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Based on other clinical trial results it was unlikely the study would meet the efficacy endpoints
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diamyd Therapeutics AB

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes. Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, Diamyd, rhGAD65, GAD, GAD-alum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on days 90 and 270.
Arm Title
B
Arm Type
Active Comparator
Arm Description
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on days 90 and 270.
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
This arm will receive 4 injections of placebo, 1 each on days 1, 30, 90 and 270.
Intervention Type
Drug
Intervention Name(s)
rhGAD65
Intervention Description
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
Intervention Type
Drug
Intervention Name(s)
rhGAD65
Intervention Description
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injected subcutaneously at days 1, 30, 90 and 270.
Primary Outcome Measure Information:
Title
Meal Stimulated C-peptide (area under the curve)
Time Frame
15 months
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
15 months
Title
Insulin Dose
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening Fasting C-peptide level at time of screening above 0.1 nmol/L Elevated GAD65 antibodies (GADA) at time of screening Male and female patients between 10 and 20 years of age Main Exclusion Criteria: Treatment with immunosuppressants or any anti-diabetic medications other than insulin A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc) Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine Participation in other clinical trials with a new chemical entity within the previous 3 months Pregnancy or planned pregnancy within 1 year after the last Diamyd dose Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Palmer, Professor
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Alex Endocrine Associates
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Children's Hospital Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Christina Care Research institute
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Florida
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Miami Children's Hospital Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Iowa Hospitals and Clinicals
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Mid America Diabetes Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67211
Country
United States
Facility Name
University of Kentucky College of Medicine
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville Research Foundation
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Children's Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Alzohaili Medical Consultants
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
St. Louis Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Kathryn Eckert
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Naomi Berrie Diabetes Center of Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Institute for Human Performance
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
University of Oklahoma, Schustermann Center Clinic
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Regional Medical Clinic - Endocrinology
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
LeBonheur Children's Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
CHRISTUS Santa Rosa Children's Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Benaroya Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18843118
Citation
Ludvigsson J, Faresjo M, Hjorth M, Axelsson S, Cheramy M, Pihl M, Vaarala O, Forsander G, Ivarsson S, Johansson C, Lindh A, Nilsson NO, Aman J, Ortqvist E, Zerhouni P, Casas R. GAD treatment and insulin secretion in recent-onset type 1 diabetes. N Engl J Med. 2008 Oct 30;359(18):1909-20. doi: 10.1056/NEJMoa0804328. Epub 2008 Oct 8.
Results Reference
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PubMed Identifier
22296077
Citation
Ludvigsson J, Krisky D, Casas R, Battelino T, Castano L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Aman J, Kardell G, Neiderud Helsingborg J, Lundstrom G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanas R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NO, Akesson CG, Keskinen P, Veijola R, Talvitie T, Raile K, Kapellen T, Burger W, Neu A, Engelsberger I, Heidtmann B, Bechtold S, Leslie D, Chiarelli F, Cicognani A, Chiumello G, Cerutti F, Zuccotti GV, Gomez Gila A, Rica I, Barrio R, Clemente M, Lopez Garcia MJ, Rodriguez M, Gonzalez I, Lopez JP, Oyarzabal M, Reeser HM, Nuboer R, Stouthart P, Bratina N, Bratanic N, de Kerdanet M, Weill J, Ser N, Barat P, Bertrand AM, Carel JC, Reynaud R, Coutant R, Baron S. GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. N Engl J Med. 2012 Feb 2;366(5):433-42. doi: 10.1056/NEJMoa1107096.
Results Reference
background
PubMed Identifier
21714999
Citation
Wherrett DK, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Herold KC, Marks JB, Monzavi R, Moran A, Orban T, Palmer JP, Raskin P, Rodriguez H, Schatz D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet GAD Study Group. Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial. Lancet. 2011 Jul 23;378(9788):319-27. doi: 10.1016/S0140-6736(11)60895-7. Epub 2011 Jun 27.
Results Reference
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A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT

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