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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by AtheroGenics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
AtheroGenics
ClinicalTrials.gov Identifier:
NCT00525577
First received: September 4, 2007
Last updated: February 4, 2008
Last verified: February 2008
  Purpose

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


Condition Intervention Phase
Diabetes
Drug: Placebo
Drug: AGI-1067
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: AGI-1067 as a Novel Antidiabetic Agent Evaluation Study

Resource links provided by NLM:


Further study details as provided by AtheroGenics:

Primary Outcome Measures:
  • Change from baseline in HbA1c to the 6-month time point is identical in the study groups (placebo and AGI-1067 treatment groups) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Change of HbA1c from baseline throughout the study • Change of FPG from baseline throughout the study• [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 1012
Study Start Date: August 2007
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1:A
Placebo
Drug: Placebo
Placebo tablet, once daily
Experimental: 2:B
AGI-1067 75 mg
Drug: AGI-1067
75 mg AGI-1067 tablet, once daily
Other Name: AGI-1067 (succinobucol)
Experimental: 3:C
AGI-1067 150 mg
Drug: AGI-1067
150 mg AGI-1067 Tablet, once daily
Other Name: AGI-1067 (succinobucol)

  Eligibility

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

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 for a 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 minimum level 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, it must be of the sulphonylurea, metformin, or glitazone class, and the dosage must have been stable for the last 3 months prior to the Screening 1 visit. Note that no combination medications (i.e., counted as more than 1 agent) will be permitted prior to Randomization and that the use of GLP mimetrics, DPPIV inhibitors, or colesevelam are not permitted (rescue medication will be allowed at 3 months).
  5. Subjects who are using hormone replacement therapy must have been on stable doses of their hormone replacement therapy for at least 3 months prior to the Screening 1 visit.
  6. Females must not be breast feeding or pregnant. If they are of child-bearing potential, they must be using a reliable method of birth control considered suitable by the Investigator. If on hormonal contraceptives for more than 6 months, subjects will be allowed to participate in the study provided that this therapy remains constant throughout the study and for a period of 2 months after the end of the study.

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) at either 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 >7 days within the last 3 months.
  5. Require parenteral corticosteroids or recurrent continuous oral corticosteroid treatment (>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 the Screening 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 antidiabetic medication changed, in the last 3 months prior to the Screening 1 visit.
  8. Have had a stroke, MI, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), or admission with unstable angina within the last 6 months 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 3 months.
  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, aspartate aminotransferase [AST], alanine aminotransferase [ALT] >1.5 times upper limit of normal [ULN]) as determined by core lab analysis at either the Screening 1 visit or the Screening 2 visits.
  15. Subjects with long QT syndrome as evidence by a QTc at the Screening 1 visit of >460 msec in males or >480 msec in females or subjects taking and requiring continued therapy with antiarrhythmic medications such as sotalol, quinidine, dofetilide, amiodarone or other drugs known to significantly prolong the QT interval (this will not include drugs associated with minor effect on the QT interval of less than 15 msec.)
  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 in this study).
  17. Have had a life-threatening illness or any history of cancer or malignancy within the past 5 years (except for basal cell carcinoma).
  18. Have had surgery requiring inpatient admission within 30 days prior to the Screening 1 visit.
  19. Considered unreliable as a study participant based on the Investigator's (or designee'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 study entry, or expects to participate in any other investigational drug study during the course of ANDES.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525577

  Hide Study Locations
Locations
United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Texas
Diabetes and Glandular Disease
San Antonio, Texas, United States, 78237
Bosnia and Herzegovina
Clinic for the Internal Medicine-Clinical Center Banja Luka
Banja Luka, Bosnia and Herzegovina
Former Serbia and Montenegro
Institute for Endocrinology, Diabetes and Metabolic-Clinical Center Serbia
Belgrade, Former Serbia and Montenegro
Clinic for the Internal Medicine-Clinical Cente Bijelo Polje
Bijelo Polje, Former Serbia and Montenegro
Clinic for the Internal Medicine-Clinical Cente Kotor
Kotor, Former Serbia and Montenegro
Clinic for the Internal Medicine-Clinical Cente Kragujevac
Kragujevac, Former Serbia and Montenegro
Clinic of endocrinologyClinical Center Nis
Nis, Former Serbia and Montenegro
Clinic for the Internal Medicine-Clinical Center Podgorica
Podgorica, Former Serbia and Montenegro
Georgia
Diagnostic Services Ltd.
Tbilisi, Georgia
Healthy Life Center
Tbilisi, Georgia
Georgian Diabetes Center
Tbilisi, Georgia
Institute of Cardiology
Tbilisi, Georgia
Center of Endocrinology, Metabology & Nutriology
Tbilisi, Georgia
Tbilisi State Medical University Clinic #1
Tbilisi, Georgia
Tbilisi Center of Endocrinology
Tbilisi, Georgia
India
Shantiniketan Hospital
Ahmedabad, India
Second floor , Silver Brook Building,
Ahmedabad, India
Bangalore Diabetes
Bangalore, India
St. Johns Medical College and Hospital,
Bangalore, India
M.s. Ramaiah Memorial Hospital
Bangalore, India
Bhagwan Mahaveer Jain Hospital
Bangalore, India
Belgaum Diabetes Centre
Belgaum, India
Madras Research Center
Chennai, India
Dr. V Seshiah Diabetes Care and Research Institute
Chennai, India
Sri Ramachandra Medical Centre
Chennai, India
Amrita Institute of Medical Sciences
Cochin, India
Medwin Hospitals
Hyderabaad, India
Mediciti Hospital, 5-9-22
Hyderabaad, India
Sai's Endocrine and Growth Centre
Hyderabaad, India
Saytam Hospital and Research Centre
Jaipur, India
Diabetes, Thyroid and Endocrine
Jaipur, India
Dayanand Medical College & Hospital
Ludhiana, India
T.N.M. College & BYL Nair CH
Mumbai, India
TMMC&LTMGH, Sion Hospital
Mumbai, India
Medicine C Railway Hospital, Byculla
Mumbai, India
IRL-Synexus Clinical Research Centre
Mumbai, India
Fortis Flt. Lt. Rajan Dhall Hospital
New Dehli, India
All India Institute of Medical Sciences
New Dehli, India
Maulana Azad Medical College and Lok Nayak Hospital
New Dehli, India
Apollo Health Education Research and Foundation(AHERF)
New Dehli, India
Sir Ganga Ram Hospital
New Dehli, India
Jehangir Hospital
Pune, India
Orange Diabetes Speciality Clinic
Pune, India
SUT Hospital
Trivandrum, India
Endocrine & Diabetes Centre
Visakhapatnam, India
Macedonia, The Former Yugoslav Republic of
Clinical Hospital "Dr. Trifun Panovski"
Bitola, Macedonia, The Former Yugoslav Republic of
General Hospital, Kumanovo
Kumanovo, Macedonia, The Former Yugoslav Republic of
General Hospital, Ohrid,
Ohrid,, Macedonia, The Former Yugoslav Republic of
University Clinical Center Skopje
Skopje, Macedonia, The Former Yugoslav Republic of
South Africa
Quinta Research
Bloemfontein, South Africa
Josha Research, Rubins Building
Bloemfontein, South Africa
Tiervlei Trial Centre, Karl Bremer Hospital
Cape Town, South Africa
21 Concert Boulevard
Cape Town, South Africa
Brooklyn Medical Centre
Cape Town, South Africa
Paarl Research Centre, Medicross Paarl
Cape Town, South Africa
TREAD Research Tygerberg Hosp
Cape Town, South Africa
8 Flamco Terrace
Chatsworth, South Africa
700 Medi Centre
Durban, South Africa
203 Maxwell Centre
Durban, South Africa
Mount Edgecombe Medical Centre, Suite 15
Durban, South Africa
Randles Rd Medical Centre
Durban, South Africa
Melrose Arch
Johannesburg, South Africa
1644 Starling Street
Johannesburg, South Africa
Union Hospital, Room 209
Johannesburg, South Africa
Centre for Diabetes & Endocrinology
Johannesburg, South Africa
DJW Navorsing
Johannesburg, South Africa
Seva Sadan, Room 6
Johannesburg, South Africa
Wits Donald Gordon Clinical Trial Site
Johannesburg, South Africa
Mercantile Hospital
Port elizabeth, South Africa
122 Louis Pasteur Building
Pretoria, South Africa
Eastmed Medical Centre
Pretoria, South Africa
GCT Trial Centre Jubilee, Jubilee Hospital
Pretoria, South Africa
456 Leyd Steer
Pretoria, South Africa
The Bay Hospital, Suite M5
Richards Bay, South Africa
Helderberg Diabetes and Medical Centre
Somerset West, South Africa
14 Medgate Medical Centre
Umhlanga, South Africa
Ukraine
Department of Endocrinology of Bukovina State Medical University
Chernivtsy, Ukraine
Institute of Problem of Endocrinological Pathology UAMS.
Kharkov, Ukraine
Kharkov Regional Clinical Hospital
Kharkov, Ukraine
Ukrainian Scientific and Practical Center of Endocrinology Surgery
Kiev, Ukraine
Bogomolets National Medical University
Kiev, Ukraine
Department of Endocrinology, Scientific Center of Radiation Medicine
Kiev, Ukraine
Komisarenko Institute of Endocrinology and Metabolism of UAMS
Kiev, Ukraine
Lviv Regional Endocrinology Health Center
Lviv, Ukraine
Odessa State Medical University.
Odessa, Ukraine
M.V. Sklifosovskiy Regional Clinical Hospital.
Poltava, Ukraine
Semashko Republic Clinical Hospital
Simferopol, Ukraine
Reginal Clinical Endocrinological Health Center
Vinnitsa, Ukraine
Basin Clinical Hospital
Zaporizhya, Ukraine
Sponsors and Collaborators
AtheroGenics
Investigators
Study Chair: Walker Long, MD AtheroGenics, Inc
  More Information

No publications provided

Responsible Party: Walker Long, MD, AtheroGenics, Inc
ClinicalTrials.gov Identifier: NCT00525577     History of Changes
Other Study ID Numbers: AGI-1067-052
Study First Received: September 4, 2007
Last Updated: February 4, 2008
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council
India: Ministry of Health
Georgia: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Ukraine: Ministry of Health
Macedonia: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by AtheroGenics:
Type 2 diabetes, glycemic control

Additional relevant MeSH terms:
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014