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This multicenter, open-label extension study of Protocol 2993-112 is designed to assess long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate long-term safety and tolerability in subjects treated with metformin who receive subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing Protocol 2993-112 are eligible to enroll.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label AC2993 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC2993 | Drug | 4-Week transition of AC2993 5 mcg subcutaneously injected twice daily followed by an open-ended period through study termination (up to 52 weeks) of AC2993 10 mcg subcutaneously injected twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination) | Change in HbA1c from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively. | Day 1 of study 2993-112 through extension study termination (up to Week 52) |
| Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination) | Change in body weight (KG) from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively. | Day 1 of study 2993-112 through extension study termination (up to Week 52) |
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All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception:
Individuals meeting any of the following criteria are to be excluded from the study unless the sponsor grants an exception:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Parkway Medical Center |
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|
| Birmingham |
| Alabama |
| 35206 |
| United States |
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | United States |
| Eclectic Family Care | Eclectic | Alabama | 36024 | United States |
| Winston Physician Services | Haleyville | Alabama | 35565 | United States |
| Simon Williamson Clinic | Hueytown | Alabama | 35023 | United States |
| Extended Arm Physicians/ Southern Drug | Montgomery | Alabama | 36106 | United States |
| Southern Drug Research Network | Tallassee | Alabama | 36078 | United States |
| Mesa Center for Clinical Research | Chandler | Arizona | 85224 | United States |
| Clinic of Physicians and Surgeons, Ltd. | Mesa | Arizona | 85201 | United States |
| ANA Ventures, LLC | Mesa | Arizona | 85204 | United States |
| Lovelace Scientific Resources | Phoenix | Arizona | 85016 | United States |
| Physicians at the Peak | Phoenix | Arizona | 85020 | United States |
| Advanced Clinical Therapeutics | Tucson | Arizona | 85712 | United States |
| First Care Family Doctors | Fayetteville | Arkansas | 72701 | United States |
| CAVHS | Little Rock | Arkansas | 72205 | United States |
| Physicians Group Research Clinic, LLC | Little Rock | Arkansas | 72205 | United States |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States |
| Endocrine Metabolic Medical Center | Atherton | California | 94027 | United States |
| Mitchell Research Group, Inc. | Bakersfield | California | 93309 | United States |
| William Zigrang, M.D. | Burlingame | California | 94010 | United States |
| International Clinical Research Network | Chula Vista | California | 91910 | United States |
| Arrowhead Regional Medical Center | Colton | California | 92324 | United States |
| East Bay Clinical Trial Center | Concord | California | 94520 | United States |
| Medical Group of Encino | Encino | California | 91436 | United States |
| Mowry Clinical Research | Fremont | California | 94538 | United States |
| SARC Research Center | Fresno | California | 93720-2955 | United States |
| Valley Research | Fresno | California | 93720 | United States |
| Irvine Clinical Research Center | Irvine | California | 92618 | United States |
| Whittier Institute for Diabetes | La Jolla | California | 92037 | United States |
| Harriman Jones Medical Group | Long Beach | California | 90806 | United States |
| Richard Cherlin, M.D. | Los Gatos | California | 95032 | United States |
| Tushar Modi, M.D. | Modesto | California | 95350 | United States |
| Dr. Martinez Medical Clinic | Moreno Valley | California | 92553 | United States |
| Arroyo Seco Medical Group | Pasadena | California | 91105 | United States |
| Elke Jost-Vu, M.D. | Rancho Mirage | California | 92270 | United States |
| Comprehensive Diabetes-Endocrine Medical Associates | Redwood City | California | 94062 | United States |
| nTouch | San Diego | California | 92103 | United States |
| Radiant Research | San Diego | California | 92108 | United States |
| San Diego Endocrine and Medical Clinic | San Diego | California | 92108 | United States |
| Veterans Medical Research Foundation | San Diego | California | 92161 | United States |
| Diabetes Research Institute of Mills Peninsula | San Mateo | California | 94401 | United States |
| Advanced Clinical Research Institute | Santa Ana | California | 92701 | United States |
| Pacific Clinical Research | Santa Monica | California | 90404 | United States |
| West Coast Clinical Trials | Signal Hill | California | 90755 | United States |
| Protocare Trials at Sharp Mission Park | Vista | California | 92083 | United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| University of Colorado-Barbara Davis Center for Childhood Diabetes | Denver | Colorado | 80262 | United States |
| Pheonix International Medicine Associates | Waterbury | Connecticut | 06708 | United States |
| Health Core at Health Care Center Christiana | Newark | Delaware | 19713 | United States |
| Medstar Clinical Research | Washington D.C. | District of Columbia | 20003-4393 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Morton Plant Mease Health Care | Clearwater | Florida | 33756 | United States |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | United States |
| Atlantic Institute of Clinical Research | Daytona Beach | Florida | 32114 | United States |
| Halifax Clinical Research Institute | Daytona Beach | Florida | 32114 | United States |
| Internal Medical Associates | Fort Myers | Florida | 33901 | United States |
| Clin Sci International | Gainesville | Florida | 32605 | United States |
| University of FL | Gainesville | Florida | 32610-0226 | United States |
| South Florida Clinical Research Center | Hollywood | Florida | 33023 | United States |
| Health Trials 3000 | Jacksonville | Florida | 32250 | United States |
| Jupiter Research Institute | Jupiter | Florida | 33458 | United States |
| ICSL Clinical Studies | Maitland | Florida | 32751 | United States |
| Baptist Diabetes Associates | Miami | Florida | 33176 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | United States |
| VRG Research | Orlando | Florida | 32801 | United States |
| Highland Lakes Medical Center | Palm Harbor | Florida | 34684 | United States |
| Tallahassee Endocrine Associates | Tallahassee | Florida | 32308 | United States |
| Biostator / USF Diabetes Center | Tampa | Florida | 33612 | United States |
| Tampa Medical Group | Tampa | Florida | 33614 | United States |
| Diabetes and Endocrine Associates of the Treasure Co | Vero Beach | Florida | 32967 | United States |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | United States |
| Radiant Research | West Palm Beach | Florida | 33407 | United States |
| ICSL-Clinical Studies | Atlanta | Georgia | 30328 | United States |
| Clinical Research Atlanta | Atlanta | Georgia | 30342 | United States |
| Columbus Metabolic Foundation | Columbus | Georgia | 31901 | United States |
| nTouch Research Corporation | Decatur | Georgia | 30033 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96813 | United States |
| Radiant Research | Honolulu | Hawaii | 96814 | United States |
| St. Luke's Family Health | Meridian | Idaho | 83642 | United States |
| University Primary Care Center at Belvidere | Belvidere | Illinois | 61008 | United States |
| Northwestern Memorail Physicians Group | Chicago | Illinois | 60602 | United States |
| Illinois Center for Clinical Trials | Chicago | Illinois | 60610 | United States |
| Cook County Hospital | Chicago | Illinois | 60612 | United States |
| Lake Forest Internal Medicine | Libertyville | Illinois | 60048 | United States |
| Winchester Research Group | Libertyville | Illinois | 60048 | United States |
| Springfield Clinic | Springfield | Illinois | 62703 | United States |
| Springfield Diabetes and Endocrinology | Springfield | Illinois | 62704 | United States |
| Medical Group of Fort Wayne | Fort Wayne | Indiana | 46804 | United States |
| Indiana University Outpatient Clinical Research | Indianapolis | Indiana | 46202 | United States |
| American Health Network | Indianapolis | Indiana | 46222 | United States |
| Center for Metabolic and Hormonal Disorders | Indianapolis | Indiana | 46260 | United States |
| nTouch Research Corporation | South Bend | Indiana | 46601 | United States |
| Ramona Holiday Diabetes Center | Des Moines | Iowa | 50314 | United States |
| Diabetes Clinical Research and Programs | Iowa City | Iowa | 52242-1009 | United States |
| Lipid, Atherosclerosis & Metabolic Clinic | Kansas City | Kansas | 66160 | United States |
| Kentucky Diabetes Center | Lexington | Kentucky | 40503 | United States |
| Central Kentucky Research Associates | Lexington | Kentucky | 40509 | United States |
| University of Kentucky Metabolic Research Group | Lexington | Kentucky | 40536-9841 | United States |
| MedResearch, Inc. | Louisville | Kentucky | 40223 | United States |
| Drug Research Services | Metairie | Louisiana | 70001 | United States |
| New Orleans Institute of Clinical Investigation | New Orleans | Louisiana | 70112 | United States |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | United States |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | United States |
| Diabetes, Endocrine and Nutrition Center | Bangor | Maine | 04401 | United States |
| VA Medical Center | Baltimore | Maryland | 21201 | United States |
| St. Agnes Health Care | Baltimore | Maryland | 21229 | United States |
| Doctors Research Associates of Maryland | Lanham | Maryland | 20706 | United States |
| University of Michigan-Endocrinology and Metabolism | Ann Arbor | Michigan | 48109 | United States |
| Grunberger Diabetes Medical Center | Bloomfield Hills | Michigan | 48302 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Grand Rapids Associated Interns | Grand Rapids | Michigan | 49506 | United States |
| Westside Family Medical Center | Kalamazoo | Michigan | 49009 | United States |
| Mayo Clinic, Division of Endocrinology and Metabolism | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Diabetes and Endocrinology Specialists | Chesterfield | Missouri | 63017 | United States |
| Midwest Pharmaceutical Research | City of Saint Peters | Missouri | 63376 | United States |
| Medical Arts Research Collaborative | Excelsior Springs | Missouri | 64024 | United States |
| St Lukes Lipid and Diabetes Research Center | Kansas City | Missouri | 64111 | United States |
| Mid Missouri Research Specialists, Inc. | Rolla | Missouri | 65401 | United States |
| St. Louis Center for Clinical Research | St Louis | Missouri | 63128 | United States |
| Radiant Research | St Louis | Missouri | 63141 | United States |
| Mercury Street Medical | Butte | Montana | 59701 | United States |
| Creighton Diabetes Center | Omaha | Nebraska | 68131 | United States |
| Lovelace Scientific Resources | Las Vegas | Nevada | 89102 | United States |
| ICSL | Las Vegas | Nevada | 89106 | United States |
| Endocrinology and Diabetes Consultants, P.C. | Dover | New Hampshire | 03820 | United States |
| HIS Clinical Research | Jersey City | New Jersey | 07306 | United States |
| Radiant Research | Moorestown | New Jersey | 08057 | United States |
| Matrix Research Institute | Mount Laurel | New Jersey | 08054 | United States |
| New Jersey Physicians | Passaic | New Jersey | 07055 | United States |
| Anderson and Collins Clinical Research, Inc. | South Plainfield | New Jersey | 07080 | United States |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | United States |
| SUNY Downstate | Brooklyn | New York | 11203 | United States |
| Medical Network Services, P.C. | Brooklyn | New York | 11230 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| St. Lukes Roosevelt Hospital | New York | New York | 10025 | United States |
| Irving Diabetes Research Unit at Columbia University | New York | New York | 10032 | United States |
| Naomi Berrie Diabetes Center at Columbia University | New York | New York | 10032 | United States |
| Heights Medical Care | New York | New York | 10033 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Albert Einstein College of Medicine of Yeshiva University | The Bronx | New York | 10467 | United States |
| DOCS at Beth Israel Medical Center | Yonkers | New York | 10710 | United States |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | United States |
| Charlotte Clinical Research | Charlotte | North Carolina | 28211 | United States |
| UNC Diabetes Care Center | Durham | North Carolina | 27713 | United States |
| Unifour Medical Research | Hickory | North Carolina | 28601 | United States |
| New Hanover Medical Research Associates | Wilmington | North Carolina | 28412 | United States |
| Piedmont Medical Research | Winston-Salem | North Carolina | 27103 | United States |
| Rapid Medical Research | Cleveland | Ohio | 44124 | United States |
| Ohio State University-Division of Endocrinology | Columbus | Ohio | 43210 | United States |
| Radiant Research | Columbus | Ohio | 43212 | United States |
| University Mednet | Mentor | Ohio | 44060 | United States |
| Comprehensive Research Services, Inc. | Mogadore | Ohio | 44260 | United States |
| North Coast Institute of Diabetes and Endocrinology | Westlake | Ohio | 44145 | United States |
| Prime Care Clinical Research | Clinton | Oklahoma | 73601 | United States |
| COR Clinical Research | Oklahoma City | Oklahoma | 73103 | United States |
| OU Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| nTouch Research Corporation | Oklahoma City | Oklahoma | 73112 | United States |
| Utica Park Clinic | Tulsa | Oklahoma | 74104 | United States |
| Americas Doctors | Medford | Oregon | 97504 | United States |
| Medford Medical Clinic | Medford | Oregon | 97504 | United States |
| Radiant Research | Portland | Oregon | 97201 | United States |
| Portland Diabetes and Endocrinology Center | Portland | Oregon | 97210 | United States |
| Pacific Coast Clinical Coordinators, Inc. | Portland | Oregon | 97214 | United States |
| Legacy Clinical Research | Portland | Oregon | 97232 | United States |
| Physicians for Clinical Research | Camp Hill | Pennsylvania | 17011 | United States |
| Argus Research Laboratories | Horsham | Pennsylvania | 19044-12297 | United States |
| Thomas Jefferson University Diabetes Research Center | Philadelphia | Pennsylvania | 19107 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Philadelphia Health Associates | Philadelphia | Pennsylvania | 19146 | United States |
| Elite Medical Research, Inc. | Sellersville | Pennsylvania | 18960 | United States |
| Tipton Medical and Diagnostic Center | Tipton | Pennsylvania | 16684 | United States |
| Safe Harbor Clinical Research | East Providence | Rhode Island | 02914 | United States |
| ICSL-Providence | East Providence | Rhode Island | 02915 | United States |
| Radiant Research | Charleston | South Carolina | 29407 | United States |
| CNS Clinical Trials | Chester | South Carolina | 29706 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Tennessee Valley Clinical Research Associates | Alcoa | Tennessee | 37701 | United States |
| Integrity Clinical Research | Jackson | Tennessee | 38305 | United States |
| Harmony Clinical Research | Johnson City | Tennessee | 37601 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Endocrine Consultants of ET | Knoxville | Tennessee | 37909 | United States |
| The Endocrine Clinic | Memphis | Tennessee | 38119 | United States |
| Integrity Clinical Research | Milan | Tennessee | 38358 | United States |
| Mid State Endocrine Associates | Nashville | Tennessee | 37203 | United States |
| Israel A. Hartman, M.D. | Arlington | Texas | 76014 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| Dallas Diabetes and Endocrinology Research Center | Dallas | Texas | 75230 | United States |
| Rafael Canadas M.D., P.A. | Dallas | Texas | 75251 | United States |
| Texas Tech University Health Sciences-Internal Medicine | El Paso | Texas | 79905 | United States |
| Internal Medicine Associates | El Paso | Texas | 79912 | United States |
| Lanier Education Research Network | Fort Worth | Texas | 76107 | United States |
| North Texas Clinical Research | Irving | Texas | 75038 | United States |
| Dr. Humberto Bruschetta | Kingsville | Texas | 78363 | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | United States |
| South Texas Applied Research | McAllen | Texas | 78503 | United States |
| Sun Research Institute | San Antonio | Texas | 78205 | United States |
| University of Texas Health Sciences Center-Texas Diabetes Institute | San Antonio | Texas | 78207 | United States |
| Diabetes and Glandular Disease Clinic | San Antonio | Texas | 78229-3894 | United States |
| SAM Clinical Research | San Antonio | Texas | 78229 | United States |
| Utah Diabetes Center at the University of Utah | Salt Lake City | Utah | 84108 | United States |
| Salt Lake Research | Salt Lake City | Utah | 84124 | United States |
| Medical Associates of Northern Virginia | Arlington | Virginia | 22204 | United States |
| Clinical Research Center-Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| Drs. Wigand, Wasserman, and Associates | Richmond | Virginia | 23225 | United States |
| Evergreen Diabetes & Endocrinology | Kirkland | Washington | 98034 | United States |
| Olympic Medical Services | Lacey | Washington | 98516 | United States |
| West Olympia Internal Medicine | Olympia | Washington | 98502 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98055 | United States |
| Northside Internal Medicine | Spokane | Washington | 99201 | United States |
| Rockwood Clinic | Spokane | Washington | 99202 | United States |
| Julia M. Hutchinson, M.D. | Spokane | Washington | 99204 | United States |
| Wenatchee Valley Clinic | Wenatchee | Washington | 98801 | United States |
| Hyperion Clinical Research | Charleston | West Virginia | 25301 | United States |
| CAMC Clinical Trials Center | Charleston | West Virginia | 25304 | United States |
| University of Wisconsin West Clinic | Madison | Wisconsin | 53711 | United States |
| Midwest Endocrinology Associates | Milwaukee | Wisconsin | 53215 | United States |
| VRG Research | Milwaukee | Wisconsin | 53226 | United States |
| Calgary Metabolic Education and Research Center | Calgary | Alberta | T3B 0M3 | Canada |
| Walter McKenzie Health Sciences Centre | Edmonton | Alberta | T6G 2B7 | Canada |
| St. Paul's Hospital, Research Services | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Health Sciences Center | Winnipeg | Manitoba | R3A 1R9 | Canada |
| University of Western Ontario | London | Ontario | N6A 4V2 | Canada |
| McGill Nutrition and Food Science Center | Montreal | Quebec | H3A 1A1 | Canada |
| Centre Hospitalier | Ste. Foy | Quebec | G1V 4G2 | Canada |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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