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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1:A | Experimental | Placebo |
|
| 2:B | Experimental | AGI-1067 75 mg |
|
| 3:C | Experimental | AGI-1067 150 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tablet, once daily |
| |
| AGI-1067 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c to the 6-month time point is identical in the study groups (placebo and AGI-1067 treatment groups) | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| • Change of HbA1c from baseline throughout the study • Change of FPG from baseline throughout the study• | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walker Long, MD | AtheroGenics, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States | ||
| Diabetes and Glandular Disease |
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| Drug |
75 mg AGI-1067 tablet, once daily |
|
|
| AGI-1067 | Drug | 150 mg AGI-1067 Tablet, once daily |
|
|
| San Antonio |
| Texas |
| 78237 |
| United States |
| Clinic for the Internal Medicine-Clinical Center Banja Luka | Banja Luka | Bosnia and Herzegovina |
| Center of Endocrinology, Metabology & Nutriology | Tbilisi | Georgia |
| Diagnostic Services Ltd. | Tbilisi | Georgia |
| Georgian Diabetes Center | Tbilisi | Georgia |
| Healthy Life Center | Tbilisi | Georgia |
| Institute of Cardiology | Tbilisi | Georgia |
| Tbilisi Center of Endocrinology | Tbilisi | Georgia |
| Tbilisi State Medical University Clinic #1 | Tbilisi | Georgia |
| Second floor , Silver Brook Building, | Ahmedabad | India |
| Shantiniketan Hospital | Ahmedabad | India |
| Bangalore Diabetes | Bangalore | India |
| Bhagwan Mahaveer Jain Hospital | Bangalore | India |
| M.s. Ramaiah Memorial Hospital | Bangalore | India |
| St. Johns Medical College and Hospital, | Bangalore | India |
| Belgaum Diabetes Centre | Belagavi | India |
| Dr. V Seshiah Diabetes Care and Research Institute | Chennai | India |
| Madras Research Center | Chennai | India |
| Sri Ramachandra Medical Centre | Chennai | India |
| Mediciti Hospital, 5-9-22 | Hyderabaad | India |
| Medwin Hospitals | Hyderabaad | India |
| Sai's Endocrine and Growth Centre | Hyderabaad | India |
| Diabetes, Thyroid and Endocrine | Jaipur | India |
| Saytam Hospital and Research Centre | Jaipur | India |
| Amrita Institute of Medical Sciences | Kochi | India |
| Dayanand Medical College & Hospital | Ludhiana | India |
| IRL-Synexus Clinical Research Centre | Mumbai | India |
| Medicine C Railway Hospital, Byculla | Mumbai | India |
| T.N.M. College & BYL Nair CH | Mumbai | India |
| TMMC<MGH, Sion Hospital | Mumbai | India |
| All India Institute of Medical Sciences | New Dehli | India |
| Apollo Health Education Research and Foundation(AHERF) | New Dehli | India |
| Fortis Flt. Lt. Rajan Dhall Hospital | New Dehli | India |
| Maulana Azad Medical College and Lok Nayak Hospital | 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 |
| Clinical Hospital "Dr. Trifun Panovski" | Bitola | North Macedonia |
| General Hospital, Kumanovo | Kumanovo | North Macedonia |
| General Hospital, Ohrid, | Ohrid | North Macedonia |
| University Clinical Center Skopje | Skopje | North Macedonia |
| Institute for Endocrinology, Diabetes and Metabolic-Clinical Center Serbia | Belgrade | Serbia and Montenegro |
| Clinic for the Internal Medicine-Clinical Cente Bijelo Polje | Bijelo Polje | Serbia and Montenegro |
| Clinic for the Internal Medicine-Clinical Cente Kotor | Kotor | Serbia and Montenegro |
| Clinic for the Internal Medicine-Clinical Cente Kragujevac | Kragujevac | Serbia and Montenegro |
| Clinic of endocrinologyClinical Center Nis | Nis | Serbia and Montenegro |
| Clinic for the Internal Medicine-Clinical Center Podgorica | Podgorica | Serbia and Montenegro |
| Josha Research, Rubins Building | Bloemfontein | South Africa |
| Quinta Research | Bloemfontein | 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 |
| Tiervlei Trial Centre, Karl Bremer Hospital | Cape Town | South Africa |
| TREAD Research Tygerberg Hosp | Cape Town | South Africa |
| 8 Flamco Terrace | Chatsworth | South Africa |
| 203 Maxwell Centre | Durban | South Africa |
| 700 Medi Centre | Durban | South Africa |
| Mount Edgecombe Medical Centre, Suite 15 | Durban | South Africa |
| Randles Rd Medical Centre | Durban | South Africa |
| 1644 Starling Street | Johannesburg | South Africa |
| Centre for Diabetes & Endocrinology | Johannesburg | South Africa |
| DJW Navorsing | Johannesburg | South Africa |
| Melrose Arch | Johannesburg | South Africa |
| Seva Sadan, Room 6 | Johannesburg | South Africa |
| Union Hospital, Room 209 | 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 |
| 456 Leyd Steer | Pretoria | South Africa |
| Eastmed Medical Centre | Pretoria | South Africa |
| GCT Trial Centre Jubilee, Jubilee Hospital | 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 |
| Department of Endocrinology of Bukovina State Medical University | Chernivtsy | Ukraine |
| Institute of Problem of Endocrinological Pathology UAMS. | Kharkiv | Ukraine |
| Kharkov Regional Clinical Hospital | Kharkiv | 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 |
| Ukrainian Scientific and Practical Center of Endocrinology Surgery | Kiev | Ukraine |
| Lviv Regional Endocrinology Health Center | Lviv | Ukraine |
| Odessa State Medical University. | Odesa | 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 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C471047 | succinobucol |
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