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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
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes
Coronary Artery Disease
 Drug: ALT-2074
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Synvista Therapeutics, Inc:

Primary Outcome Measures:
  • Biomarkers of inflammation and oxidative stress [ Time Frame: 28 days ]
  • Safety [ Time Frame: 28 days ]
  • Pharmacokinetics [ Time Frame: 28 days ]

Estimated Enrollment: 66
Study Start Date: June 2007
Study Completion Date: May 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491543

Locations
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45249
Sponsors and Collaborators
Synvista Therapeutics, Inc
Investigators
Principal Investigator: Jeffrey G Geohas, MD Radiant Research
Principal Investigator: Michale Noss, MD Radiant Reasearch
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00491543     History of Changes
Other Study ID Numbers: ALT-2074-201
Study First Received: June 23, 2007
Last Updated: July 1, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013