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Evaluation of ALT-2074 in Subjects With Type-2 Diabetes, Haptoglobin Type 2-2 Genotype and Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00491543
First received: June 23, 2007
Last updated: July 1, 2008
Last verified: June 2007

June 23, 2007
July 1, 2008
June 2007
Not Provided
  • Biomarkers of inflammation and oxidative stress [ Time Frame: 28 days ]
  • Safety [ Time Frame: 28 days ]
  • Pharmacokinetics [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT00491543 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Evaluation of ALT-2074 in Subjects With Type-2 Diabetes, Haptoglobin Type 2-2 Genotype and Coronary Artery Disease
A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ALT 2074 in Subjects With Type 2 Diabetes Who Have a Haptoglobin Type 2-2 Genotype and Coronary Artery Disease

ALT-2074 (BXT-51072) belongs to a class of drugs called "glutathione peroxidase mimics." ALT-2074 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels. Diabetic patients with a haptoglobin 2-2 genotype have poor cardiovascular clinical outcomes.

The purpose of this study is to assess the safety, the pharmacokinetic profile and characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of ALT 2074. Subjects must be diabetic, with evidence of coronary artery disease and a haptoglobin 2-2 genotype

Subjects will be male and female, 18 to 75 years old, with Type 2 diabetes mellitus, a documented or suspected history of coronary artery disease, and a Haptoglobin type 2-2 (Hp 2-2) genotype. Subjects on prescribed anti-diabetic and coronary artery disease medications may continue to take their medications throughout the study.

Subjects who qualify will receive active drug (ALT-2074 20 mg, 40 mg or 80 mg) or placebo every 8 hours for 28 days. There will be three sequential cohorts of increasing doses of active drug. There will be 2 follow-up visits (Days 35 and 42). Blood and urine tests for safety (chemistry and hematology), pharmacokinetics and relevant biomarkers to measure inflammation and oxidative stress will be performed throughout the study. Electrocardiograms and 24-hour Holter monitoring will also be performed at various time points during the study.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Diabetes
  • Coronary Artery Disease
Drug: ALT-2074
Not Provided
Blum S, Asaf R, Guetta J, Miller-Lotan R, Asleh R, Kremer R, Levy NS, Berger FG, Aronson D, Fu X, Zhang R, Hazen SL, Levy AP. Haptoglobin genotype determines myocardial infarct size in diabetic mice. J Am Coll Cardiol. 2007 Jan 2;49(1):82-7. Epub 2006 Dec 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
May 2008
Not Provided

Inclusion criteria:

  1. Male or female, 18 to 75 years of age.
  2. Diagnosis of Type 2 diabetes mellitus
  3. Stable coronary artery disease (CAD) documented or suspected, not requiring adjustment for ≥2 months, as determined by: a. A history of myocardial infarction verified by Q-wave electrocardiogram and/or medical records, occurring greater than 6 months before the screening Visit; OR b. A coronary angiogram and/or stress test; OR c. A ankle brachial pressure index less than 0.9; OR d. Age greater than 60 years of age
  4. Hp 2-2 genotype.
  5. Ability to communicate and comply with all study requirements.

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Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00491543
ALT-2074-201
No
Not Provided
Synvista Therapeutics, Inc
Not Provided
Principal Investigator: Jeffrey G Geohas, MD Radiant Research
Principal Investigator: Michale Noss, MD Radiant Reasearch
Synvista Therapeutics, Inc
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP