Phase
Condition
Diabetic Gastroparesis
Diabetic Macular Edema
Diabetic Neuropathy
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide informed written consent prior to entry.
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.
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.
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).
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.
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:
Have Type 1 diabetes or history of ketoacidosis determined by medical history
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])
Have a history of severe diabetic neuropathy including autonomic neuropathy,gastroparesis, or lower limb ulceration or amputation.
Have a history of long-term therapy with insulin (>30 days) within the last year or >7days within the last 3 months.
Require parenteral corticosteroids or recurrent continuous oral corticosteroidtreatment (>2 weeks) within the last 3 months.
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.
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.
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.
Have congestive heart failure New York Heart Association Class III or IV (Appendix B).
Have taken any of the following drugs in 6 months prior to the Screening 1 visit:cholestyramine, colestid, cyclosporine, or isotretinoin.
Have acute infections requiring parenteral antibiotic treatment within the last 3months.
Have uncontrolled hypertension (defined as systolic blood pressure >180 mmHg).
Have platelets <100,000 K/cu mm (x 103/μL) at the Screening 1 visit.
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.
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.)
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).
Have had a life-threatening illness or any history of cancer or malignancy within thepast 5 years (except for basal cell carcinoma).
Have had surgery requiring inpatient admission within 30 days prior to the Screening 1visit.
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).
Have a history of intolerance or previous use of probucol within the last 5 years.
Have participated in a previous study with AGI-1067.
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
Connect with a study center
Clinic for the Internal Medicine-Clinical Center Banja Luka
Banja Luka,
Bosnia and HerzegovinaSite Not Available
Institute for Endocrinology, Diabetes and Metabolic-Clinical Center Serbia
Belgrade,
Former Serbia and MontenegroSite Not Available
Clinic for the Internal Medicine-Clinical Cente Bijelo Polje
Bijelo Polje,
Former Serbia and MontenegroSite Not Available
Clinic for the Internal Medicine-Clinical Cente Kotor
Kotor,
Former Serbia and MontenegroSite Not Available
Clinic for the Internal Medicine-Clinical Cente Kragujevac
Kragujevac,
Former Serbia and MontenegroSite Not Available
Clinic of endocrinologyClinical Center Nis
Nis,
Former Serbia and MontenegroSite Not Available
Clinic for the Internal Medicine-Clinical Center Podgorica
Podgorica,
Former Serbia and MontenegroSite Not Available
Center of Endocrinology, Metabology & Nutriology
Tbilisi,
GeorgiaSite Not Available
Diagnostic Services Ltd.
Tbilisi,
GeorgiaSite Not Available
Georgian Diabetes Center
Tbilisi,
GeorgiaSite Not Available
Healthy Life Center
Tbilisi,
GeorgiaSite Not Available
Institute of Cardiology
Tbilisi,
GeorgiaSite Not Available
Tbilisi Center of Endocrinology
Tbilisi,
GeorgiaSite Not Available
Tbilisi State Medical University Clinic #1
Tbilisi,
GeorgiaSite Not Available
Second floor , Silver Brook Building,
Ahmedabad,
IndiaSite Not Available
Shantiniketan Hospital
Ahmedabad,
IndiaSite Not Available
Bangalore Diabetes
Bangalore,
IndiaSite Not Available
Bhagwan Mahaveer Jain Hospital
Bangalore,
IndiaSite Not Available
M.s. Ramaiah Memorial Hospital
Bangalore,
IndiaSite Not Available
St. Johns Medical College and Hospital,
Bangalore,
IndiaSite Not Available
Belgaum Diabetes Centre
Belgaum,
IndiaSite Not Available
Dr. V Seshiah Diabetes Care and Research Institute
Chennai,
IndiaSite Not Available
Madras Research Center
Chennai,
IndiaSite Not Available
Sri Ramachandra Medical Centre
Chennai,
IndiaSite Not Available
Amrita Institute of Medical Sciences
Cochin,
IndiaSite Not Available
Mediciti Hospital, 5-9-22
Hyderabaad,
IndiaSite Not Available
Medwin Hospitals
Hyderabaad,
IndiaSite Not Available
Sai's Endocrine and Growth Centre
Hyderabaad,
IndiaSite Not Available
Diabetes, Thyroid and Endocrine
Jaipur,
IndiaSite Not Available
Saytam Hospital and Research Centre
Jaipur,
IndiaSite Not Available
Dayanand Medical College & Hospital
Ludhiana,
IndiaSite Not Available
IRL-Synexus Clinical Research Centre
Mumbai,
IndiaSite Not Available
Medicine C Railway Hospital, Byculla
Mumbai,
IndiaSite Not Available
T.N.M. College & BYL Nair CH
Mumbai,
IndiaSite Not Available
TMMC<MGH, Sion Hospital
Mumbai,
IndiaSite Not Available
All India Institute of Medical Sciences
New Dehli,
IndiaSite Not Available
Apollo Health Education Research and Foundation(AHERF)
New Dehli,
IndiaSite Not Available
Fortis Flt. Lt. Rajan Dhall Hospital
New Dehli,
IndiaSite Not Available
Maulana Azad Medical College and Lok Nayak Hospital
New Dehli,
IndiaSite Not Available
Sir Ganga Ram Hospital
New Dehli,
IndiaSite Not Available
Jehangir Hospital
Pune,
IndiaSite Not Available
Orange Diabetes Speciality Clinic
Pune,
IndiaSite Not Available
SUT Hospital
Trivandrum,
IndiaSite Not Available
Endocrine & Diabetes Centre
Visakhapatnam,
IndiaSite Not Available
Clinical Hospital "Dr. Trifun Panovski"
Bitola,
Macedonia, The Former Yugoslav Republic ofSite Not Available
General Hospital, Kumanovo
Kumanovo,
Macedonia, The Former Yugoslav Republic ofSite Not Available
General Hospital, Ohrid,
Ohrid,,
Macedonia, The Former Yugoslav Republic ofSite Not Available
University Clinical Center Skopje
Skopje,
Macedonia, The Former Yugoslav Republic ofSite Not Available
Josha Research, Rubins Building
Bloemfontein,
South AfricaSite Not Available
Quinta Research
Bloemfontein,
South AfricaSite Not Available
21 Concert Boulevard
Cape Town,
South AfricaSite Not Available
Brooklyn Medical Centre
Cape Town,
South AfricaSite Not Available
Paarl Research Centre, Medicross Paarl
Cape Town,
South AfricaSite Not Available
TREAD Research Tygerberg Hosp
Cape Town,
South AfricaSite Not Available
Tiervlei Trial Centre, Karl Bremer Hospital
Cape Town,
South AfricaSite Not Available
8 Flamco Terrace
Chatsworth,
South AfricaSite Not Available
203 Maxwell Centre
Durban,
South AfricaSite Not Available
700 Medi Centre
Durban,
South AfricaSite Not Available
Mount Edgecombe Medical Centre, Suite 15
Durban,
South AfricaSite Not Available
Randles Rd Medical Centre
Durban,
South AfricaSite Not Available
1644 Starling Street
Johannesburg,
South AfricaSite Not Available
Centre for Diabetes & Endocrinology
Johannesburg,
South AfricaSite Not Available
DJW Navorsing
Johannesburg,
South AfricaSite Not Available
Melrose Arch
Johannesburg,
South AfricaSite Not Available
Seva Sadan, Room 6
Johannesburg,
South AfricaSite Not Available
Union Hospital, Room 209
Johannesburg,
South AfricaSite Not Available
Wits Donald Gordon Clinical Trial Site
Johannesburg,
South AfricaSite Not Available
Mercantile Hospital
Port elizabeth,
South AfricaSite Not Available
122 Louis Pasteur Building
Pretoria,
South AfricaSite Not Available
456 Leyd Steer
Pretoria,
South AfricaSite Not Available
Eastmed Medical Centre
Pretoria,
South AfricaSite Not Available
GCT Trial Centre Jubilee, Jubilee Hospital
Pretoria,
South AfricaSite Not Available
The Bay Hospital, Suite M5
Richards Bay,
South AfricaSite Not Available
Helderberg Diabetes and Medical Centre
Somerset West,
South AfricaSite Not Available
14 Medgate Medical Centre
Umhlanga,
South AfricaSite Not Available
Department of Endocrinology of Bukovina State Medical University
Chernivtsy,
UkraineSite Not Available
Institute of Problem of Endocrinological Pathology UAMS.
Kharkov,
UkraineSite Not Available
Kharkov Regional Clinical Hospital
Kharkov,
UkraineSite Not Available
Bogomolets National Medical University
Kiev,
UkraineSite Not Available
Department of Endocrinology, Scientific Center of Radiation Medicine
Kiev,
UkraineSite Not Available
Komisarenko Institute of Endocrinology and Metabolism of UAMS
Kiev,
UkraineSite Not Available
Ukrainian Scientific and Practical Center of Endocrinology Surgery
Kiev,
UkraineSite Not Available
Lviv Regional Endocrinology Health Center
Lviv,
UkraineSite Not Available
Odessa State Medical University.
Odessa,
UkraineSite Not Available
M.V. Sklifosovskiy Regional Clinical Hospital.
Poltava,
UkraineSite Not Available
Semashko Republic Clinical Hospital
Simferopol,
UkraineSite Not Available
Reginal Clinical Endocrinological Health Center
Vinnitsa,
UkraineSite Not Available
Basin Clinical Hospital
Zaporizhya,
UkraineSite Not Available
Clinical Research Atlanta
Stockbridge, Georgia 30281
United StatesSite Not Available
Diabetes and Glandular Disease
San Antonio, Texas 78237
United StatesSite Not Available
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