ANDES-AGI-1067 as a Novel Antidiabetic Agent Evaluation Study

Last updated: February 4, 2008
Sponsor: AtheroGenics
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Diabetic Gastroparesis

Diabetic Macular Edema

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT00525577
AGI-1067-052
  • Ages 18-75
  • All Genders

Study Summary

This double-blind, placebo-controlled, dose-finding study is designed to identify the lowest AGI-1067 dose that improves glycemic control as measured by HbA1c and fasting glucose in subjects with Type 2 diabetes mellitus. Glycemic control will be measured during a 6-month treatment period in subjects who are on 1 or no antidiabetic drugs

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provide informed written consent prior to entry.

  2. Be male or female 18-75 years of age at the time of entry and have Type 2 diabetes fora minimum of 6 months prior to Screening 1 visit.

  3. Have an HbA1c level measured at the Screening 1 and Screening 2 visits with a minimumlevel at ≥7.5% for both visits, as determined by the core lab analysis.

  4. Be taking either 1 or no antidiabetic agents. If on an antidiabetic medication, itmust be of the sulphonylurea, metformin, or glitazone class, and the dosage must havebeen stable for the last 3 months prior to the Screening 1 visit. Note that nocombination medications (i.e., counted as more than 1 agent) will be permitted priorto Randomization and that the use of GLP mimetrics, DPPIV inhibitors, or colesevelamare not permitted (rescue medication will be allowed at 3 months).

  5. Subjects who are using hormone replacement therapy must have been on stable doses oftheir hormone replacement therapy for at least 3 months prior to the Screening 1visit.

  6. Females must not be breast feeding or pregnant. If they are of child-bearingpotential, they must be using a reliable method of birth control considered suitableby the Investigator. If on hormonal contraceptives for more than 6 months, subjectswill be allowed to participate in the study provided that this therapy remainsconstant throughout the study and for a period of 2 months after the end of the study.

Exclusion

Exclusion Criteria:

  1. Have Type 1 diabetes or history of ketoacidosis determined by medical history

  2. Have an HbA1c of more than 10.5% or a fasting glucose of >240 mg/dL (13.3 mmol/L) ateither the Screening 1 [Visit 1] or Screening 2 [Visit 2])

  3. Have a history of severe diabetic neuropathy including autonomic neuropathy,gastroparesis, or lower limb ulceration or amputation.

  4. Have a history of long-term therapy with insulin (>30 days) within the last year or >7days within the last 3 months.

  5. Require parenteral corticosteroids or recurrent continuous oral corticosteroidtreatment (>2 weeks) within the last 3 months.

  6. Use weight loss drugs (e.g., orlistat, sibutramine, phenylpropanolamine, phentermine,or similar prescription or over-the-counter medications) within 3 months of theScreening 1 visit or intentional weight loss of ≥4 kg in the previous 6 months.

  7. Have had a new antidiabetic medication added, or the dose of an existing antidiabeticmedication changed, in the last 3 months prior to the Screening 1 visit.

  8. Have had a stroke, MI, coronary artery bypass graft (CABG), percutaneous transluminalcoronary angioplasty (PTCA), or admission with unstable angina within the last 6months prior to the Screening 1 visit.

  9. Have congestive heart failure New York Heart Association Class III or IV (Appendix B).

  10. Have taken any of the following drugs in 6 months prior to the Screening 1 visit:cholestyramine, colestid, cyclosporine, or isotretinoin.

  11. Have acute infections requiring parenteral antibiotic treatment within the last 3months.

  12. Have uncontrolled hypertension (defined as systolic blood pressure >180 mmHg).

  13. Have platelets <100,000 K/cu mm (x 103/μL) at the Screening 1 visit.

  14. Have active liver disease or hepatic dysfunction (total bilirubin, aspartateaminotransferase [AST], alanine aminotransferase [ALT] >1.5 times upper limit ofnormal [ULN]) as determined by core lab analysis at either the Screening 1 visit orthe Screening 2 visits.

  15. Subjects with long QT syndrome as evidence by a QTc at the Screening 1 visit of >460msec in males or >480 msec in females or subjects taking and requiring continuedtherapy with antiarrhythmic medications such as sotalol, quinidine, dofetilide,amiodarone or other drugs known to significantly prolong the QT interval (this willnot include drugs associated with minor effect on the QT interval of less than 15msec.)

  16. Have known major chronic infection or major hematologic, renal, metabolic,gastrointestinal or endocrine dysfunction in the judgment of the Investigator (including diabetes mellitus too severe to allow the subject to safely participate inthis study).

  17. Have had a life-threatening illness or any history of cancer or malignancy within thepast 5 years (except for basal cell carcinoma).

  18. Have had surgery requiring inpatient admission within 30 days prior to the Screening 1visit.

  19. Considered unreliable as a study participant based on the Investigator's (ordesignee's) knowledge of the subject (e.g., history of alcohol or other drug abuse,inability or unwillingness to adhere to the protocol, or psychosis).

  20. Have a history of intolerance or previous use of probucol within the last 5 years.

  21. Have participated in a previous study with AGI-1067.

  22. Have participated in any investigational drug study within 30 days prior to studyentry, or expects to participate in any other investigational drug study during thecourse of ANDES.

Study Design

Total Participants: 1012
Study Start date:
August 01, 2007
Estimated Completion Date:
September 30, 2008

Connect with a study center

  • Clinic for the Internal Medicine-Clinical Center Banja Luka

    Banja Luka,
    Bosnia and Herzegovina

    Site Not Available

  • Institute for Endocrinology, Diabetes and Metabolic-Clinical Center Serbia

    Belgrade,
    Former Serbia and Montenegro

    Site Not Available

  • Clinic for the Internal Medicine-Clinical Cente Bijelo Polje

    Bijelo Polje,
    Former Serbia and Montenegro

    Site Not Available

  • Clinic for the Internal Medicine-Clinical Cente Kotor

    Kotor,
    Former Serbia and Montenegro

    Site Not Available

  • Clinic for the Internal Medicine-Clinical Cente Kragujevac

    Kragujevac,
    Former Serbia and Montenegro

    Site Not Available

  • Clinic of endocrinologyClinical Center Nis

    Nis,
    Former Serbia and Montenegro

    Site Not Available

  • Clinic for the Internal Medicine-Clinical Center Podgorica

    Podgorica,
    Former Serbia and Montenegro

    Site Not Available

  • Center of Endocrinology, Metabology & Nutriology

    Tbilisi,
    Georgia

    Site Not Available

  • Diagnostic Services Ltd.

    Tbilisi,
    Georgia

    Site Not Available

  • Georgian Diabetes Center

    Tbilisi,
    Georgia

    Site Not Available

  • Healthy Life Center

    Tbilisi,
    Georgia

    Site Not Available

  • Institute of Cardiology

    Tbilisi,
    Georgia

    Site Not Available

  • Tbilisi Center of Endocrinology

    Tbilisi,
    Georgia

    Site Not Available

  • Tbilisi State Medical University Clinic #1

    Tbilisi,
    Georgia

    Site Not Available

  • Second floor , Silver Brook Building,

    Ahmedabad,
    India

    Site Not Available

  • Shantiniketan Hospital

    Ahmedabad,
    India

    Site Not Available

  • Bangalore Diabetes

    Bangalore,
    India

    Site Not Available

  • Bhagwan Mahaveer Jain Hospital

    Bangalore,
    India

    Site Not Available

  • M.s. Ramaiah Memorial Hospital

    Bangalore,
    India

    Site Not Available

  • St. Johns Medical College and Hospital,

    Bangalore,
    India

    Site Not Available

  • Belgaum Diabetes Centre

    Belgaum,
    India

    Site Not Available

  • Dr. V Seshiah Diabetes Care and Research Institute

    Chennai,
    India

    Site Not Available

  • Madras Research Center

    Chennai,
    India

    Site Not Available

  • Sri Ramachandra Medical Centre

    Chennai,
    India

    Site Not Available

  • Amrita Institute of Medical Sciences

    Cochin,
    India

    Site Not Available

  • Mediciti Hospital, 5-9-22

    Hyderabaad,
    India

    Site Not Available

  • Medwin Hospitals

    Hyderabaad,
    India

    Site Not Available

  • Sai's Endocrine and Growth Centre

    Hyderabaad,
    India

    Site Not Available

  • Diabetes, Thyroid and Endocrine

    Jaipur,
    India

    Site Not Available

  • Saytam Hospital and Research Centre

    Jaipur,
    India

    Site Not Available

  • Dayanand Medical College & Hospital

    Ludhiana,
    India

    Site Not Available

  • IRL-Synexus Clinical Research Centre

    Mumbai,
    India

    Site Not Available

  • Medicine C Railway Hospital, Byculla

    Mumbai,
    India

    Site Not Available

  • T.N.M. College & BYL Nair CH

    Mumbai,
    India

    Site Not Available

  • TMMC&LTMGH, Sion Hospital

    Mumbai,
    India

    Site Not Available

  • All India Institute of Medical Sciences

    New Dehli,
    India

    Site Not Available

  • Apollo Health Education Research and Foundation(AHERF)

    New Dehli,
    India

    Site Not Available

  • Fortis Flt. Lt. Rajan Dhall Hospital

    New Dehli,
    India

    Site Not Available

  • Maulana Azad Medical College and Lok Nayak Hospital

    New Dehli,
    India

    Site Not Available

  • Sir Ganga Ram Hospital

    New Dehli,
    India

    Site Not Available

  • Jehangir Hospital

    Pune,
    India

    Site Not Available

  • Orange Diabetes Speciality Clinic

    Pune,
    India

    Site Not Available

  • SUT Hospital

    Trivandrum,
    India

    Site Not Available

  • Endocrine & Diabetes Centre

    Visakhapatnam,
    India

    Site Not Available

  • Clinical Hospital "Dr. Trifun Panovski"

    Bitola,
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • General Hospital, Kumanovo

    Kumanovo,
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • General Hospital, Ohrid,

    Ohrid,,
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • University Clinical Center Skopje

    Skopje,
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • Josha Research, Rubins Building

    Bloemfontein,
    South Africa

    Site Not Available

  • Quinta Research

    Bloemfontein,
    South Africa

    Site Not Available

  • 21 Concert Boulevard

    Cape Town,
    South Africa

    Site Not Available

  • Brooklyn Medical Centre

    Cape Town,
    South Africa

    Site Not Available

  • Paarl Research Centre, Medicross Paarl

    Cape Town,
    South Africa

    Site Not Available

  • TREAD Research Tygerberg Hosp

    Cape Town,
    South Africa

    Site Not Available

  • Tiervlei Trial Centre, Karl Bremer Hospital

    Cape Town,
    South Africa

    Site Not Available

  • 8 Flamco Terrace

    Chatsworth,
    South Africa

    Site Not Available

  • 203 Maxwell Centre

    Durban,
    South Africa

    Site Not Available

  • 700 Medi Centre

    Durban,
    South Africa

    Site Not Available

  • Mount Edgecombe Medical Centre, Suite 15

    Durban,
    South Africa

    Site Not Available

  • Randles Rd Medical Centre

    Durban,
    South Africa

    Site Not Available

  • 1644 Starling Street

    Johannesburg,
    South Africa

    Site Not Available

  • Centre for Diabetes & Endocrinology

    Johannesburg,
    South Africa

    Site Not Available

  • DJW Navorsing

    Johannesburg,
    South Africa

    Site Not Available

  • Melrose Arch

    Johannesburg,
    South Africa

    Site Not Available

  • Seva Sadan, Room 6

    Johannesburg,
    South Africa

    Site Not Available

  • Union Hospital, Room 209

    Johannesburg,
    South Africa

    Site Not Available

  • Wits Donald Gordon Clinical Trial Site

    Johannesburg,
    South Africa

    Site Not Available

  • Mercantile Hospital

    Port elizabeth,
    South Africa

    Site Not Available

  • 122 Louis Pasteur Building

    Pretoria,
    South Africa

    Site Not Available

  • 456 Leyd Steer

    Pretoria,
    South Africa

    Site Not Available

  • Eastmed Medical Centre

    Pretoria,
    South Africa

    Site Not Available

  • GCT Trial Centre Jubilee, Jubilee Hospital

    Pretoria,
    South Africa

    Site Not Available

  • The Bay Hospital, Suite M5

    Richards Bay,
    South Africa

    Site Not Available

  • Helderberg Diabetes and Medical Centre

    Somerset West,
    South Africa

    Site Not Available

  • 14 Medgate Medical Centre

    Umhlanga,
    South Africa

    Site Not Available

  • Department of Endocrinology of Bukovina State Medical University

    Chernivtsy,
    Ukraine

    Site Not Available

  • Institute of Problem of Endocrinological Pathology UAMS.

    Kharkov,
    Ukraine

    Site Not Available

  • Kharkov Regional Clinical Hospital

    Kharkov,
    Ukraine

    Site Not Available

  • Bogomolets National Medical University

    Kiev,
    Ukraine

    Site Not Available

  • Department of Endocrinology, Scientific Center of Radiation Medicine

    Kiev,
    Ukraine

    Site Not Available

  • Komisarenko Institute of Endocrinology and Metabolism of UAMS

    Kiev,
    Ukraine

    Site Not Available

  • Ukrainian Scientific and Practical Center of Endocrinology Surgery

    Kiev,
    Ukraine

    Site Not Available

  • Lviv Regional Endocrinology Health Center

    Lviv,
    Ukraine

    Site Not Available

  • Odessa State Medical University.

    Odessa,
    Ukraine

    Site Not Available

  • M.V. Sklifosovskiy Regional Clinical Hospital.

    Poltava,
    Ukraine

    Site Not Available

  • Semashko Republic Clinical Hospital

    Simferopol,
    Ukraine

    Site Not Available

  • Reginal Clinical Endocrinological Health Center

    Vinnitsa,
    Ukraine

    Site Not Available

  • Basin Clinical Hospital

    Zaporizhya,
    Ukraine

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Diabetes and Glandular Disease

    San Antonio, Texas 78237
    United States

    Site Not Available

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