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

Type 1 Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00751842
• Other study ID #: D/P3/07/5
• Status: Terminated
• Phase: Phase 3
• First received: September 11, 2008
• Last updated: October 9, 2012
• Start date: September 2008
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Diamyd Therapeutics AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 331
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
• rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
• Placebo
Placebo injected subcutaneously at days 1, 30, 90 and 270.

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Tufts Medical Center	Boston	Massachusetts
United States	Alzohaili Medical Consultants	Dearborn	Michigan
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	University of Florida	Gainsville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Rocky Mountain Diabetes and Osteoporosis Center	Idaho Falls	Idaho
United States	University of Iowa Hospitals and Clinicals	Iowa City	Iowa
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	The Children's Mercy Hospital	Kansas City	Missouri
United States	University of Kentucky College of Medicine	Lexington	Kentucky
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas
United States	University of Louisville Research Foundation	Louisville	Kentucky
United States	LeBonheur Children's Medical Center	Memphis	Tennessee
United States	Miami Children's Hospital Research Institute	Miami	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Children's Hospital	New Orleans	Louisiana
United States	Naomi Berrie Diabetes Center of Columbia University	New York	New York
United States	Christina Care Research institute	Newark	Delaware
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	Children's Hospital Orange County	Orange	California
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Regional Medical Clinic - Endocrinology	Rapid City	South Dakota
United States	Kathryn Eckert	Reno	Nevada
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Rochester	Rochester	New York
United States	Alex Endocrine Associates	Rogers	Arkansas
United States	CHRISTUS Santa Rosa Children's Hospital	San Antonio	Texas
United States	Rady Children's Hospital	San Diego	California
United States	Benaroya Research Institute	Seattle	Washington
United States	St. Louis Children's Hospital	St. Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	SUNY Institute for Human Performance	Syracuse	New York
United States	University of South Florida	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	University of Oklahoma, Schustermann Center Clinic	Tulsa	Oklahoma
United States	Mid America Diabetes Associates	Wichita	Kansas
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Diamyd Therapeutics AB

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ludvigsson J, Faresjö M, Hjorth M, Axelsson S, Chéramy 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. — View Citation

Ludvigsson J, Krisky D, Casas R, Battelino T, Castaño L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Åman J, Kärdell G, Neiderud Helsingborg J, Lundström G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanås R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NÖ, Åkesson 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, López 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meal Stimulated C-peptide (area under the curve)		15 months	No
Secondary	HbA1c		15 months	No
Secondary	Insulin Dose		15 months	No