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

Sponsored by:	Diamyd Therapeutics AB
Information provided by:	Diamyd Therapeutics AB
ClinicalTrials.gov Identifier:	NCT00751842

Purpose

The purpose of this study is 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.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus	Drug: rhGAD65 Drug: Placebo	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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)

Further study details as provided by Diamyd Therapeutics AB:

Primary Outcome Measures:

Meal Stimulated C-peptide (area under the curve) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HbA1c [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Insulin Dose [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	August 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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.	Drug: rhGAD65 Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
B: Active Comparator 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.	Drug: rhGAD65 Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
C: Placebo Comparator This arm will receive 4 injections of placebo, 1 each on days 1, 30, 90 and 270.	Drug: Placebo Placebo injected subcutaneously at days 1, 30, 90 and 270.

Eligibility

Ages Eligible for Study:	16 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 16 and 20 years of age*
- Upon FDA approval, based on initial safety data from approximately 20 treated subjects 16-20 years of age, the following age group will be added:
10-15 years

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751842

Contacts

Contact: Sharon Wolf

201-587-0500

swolf@tklresearch.com

Locations

United States, Arkansas
SFE Superior Research	Recruiting
Rogers, Arkansas, United States, 72758
Principal Investigator: Nadine H. Alex, MD
United States, California
Rady Children's Hospital	Recruiting
San Diego, California, United States, 92123
Principal Investigator: Ron Newfield, MD
United States, Florida
Clinical Trials Management	Recruiting
Boca Raton, Florida, United States, 33486
Principal Investigator: Mark Frager, MD
Clinical Trials Management	Recruiting
Pembroke Pines, Florida, United States, 33024
Principal Investigator: Fidel Henriquez, MD
Clinical Trials Management	Recruiting
Orlando, Florida, United States, 32803
Principal Investigator: William Hall, MD
Clinical Trials Management	Recruiting
Daytona Beach, Florida, United States, 33211
Principal Investigator: Timothy Valk, MD
Clinical Trials Management	Recruiting
Orlando, Florida, United States, 32835
Principal Investigator: Kimberley Bourne, MD
Clinical Trials Management	Recruiting
Winter Park, Florida, United States, 32789
Principal Investigator: Victor Roberts, MD
Clinial Trials management	Recruiting
Jupiter, Florida, United States, 33458
Principal Investigator: Gary Pepper, MD
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center	Recruiting
Idaho Falls, Idaho, United States, 83404
Principal Investigator: Carl D. Vance, MD
United States, Kentucky
Dept. of Veteran Affairs Medical Center	Recruiting
Lexington, Kentucky, United States, 40502
Principal Investigator: Dennis Karounos, MD
University of Louisville Research Foundation	Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Kupper Wintergerst, MD
United States, Maryland
University of Maryland Medical Center	Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Debra Counts, MD
United States, Michigan
Alzohaili Medical Consultants	Recruiting
Dearborn, Michigan, United States, 48126
Principal Investigator: Opada Alzohaili, MD
United States, Nevada
Kathryn Eckert	Recruiting
Reno, Nevada, United States, 89502
Principal Investigator: Kathryn Eckert, MD
United States, New York
SUNY Institute for Human Performance	Recruiting
Syracuse, New York, United States, 13210
Principal Investigator: Ruth Weinstock, MD
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Principal Investigator: Nicholas Jospe, MD
United States, Oklahoma
University of Oklahoma, Schustermann Center Clinic	Recruiting
Tulsa, Oklahoma, United States, 74135
Principal Investigator: David Jelley, MD
United States, Texas
CHRISTUS Santa Rosa Children's Hospital	Not yet recruiting
San Antonio, Texas, United States, 78207
Principal Investigator: William Rogers, MD
United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23219
Principal Investigator: Gary Francis, MD

Sponsors and Collaborators

Diamyd Therapeutics AB

Investigators

Principal Investigator:

Jerry Palmer, Professor

University of Washington

More Information

No publications provided

Responsible Party:	Diamyd Therapeutics AB ( Managing Director )
Study ID Numbers:	D/P3/07/5
Study First Received:	September 11, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00751842 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Diamyd Therapeutics AB:

Diabetes
Juvenile Diabetes
Diabetes type 1
Autoimmune Diabetes
Insulin dependent Diabetes
Type 1 diabetes

Type 1 diabetes mellitus
Diamyd
rhGAD65
GAD
GAD-alum

Study placed in the following topic categories:

Aluminum sulfate
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Disease Progression
Diabetes Mellitus

Endocrine System Diseases
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009