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Decision by Sponsor
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An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITCA 650 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITCA 650 (exenatide in DUROS) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c between Week 39 and Day 0 | 39 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| Fundamental Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29301824 | Derived | Henry RR, Rosenstock J, Denham DS, Prabhakar P, Kjems L, Baron MA. Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA1c: The FREEDOM-1 HBL (High Baseline) Study. Diabetes Care. 2018 Mar;41(3):613-619. doi: 10.2337/dc17-1519. Epub 2018 Jan 4. |
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| Gulf Shores |
| Alabama |
| 36542 |
| United States |
| East Valley Family Physicians, PLC | Chandler | Arizona | 85224 | United States |
| Desert Clinical Research | Mesa | Arizona | 85213 | United States |
| Clinical Research Advantage, Inc. | Phoenix | Arizona | 85020 | United States |
| eStudySite | Chula Vista | California | United States |
| Rocks Medical Research Institute, Inc. | Fresno | California | 93721 | United States |
| Rocks Medical Research Institute | Fresno | California | 93721 | United States |
| Long Beach Center for Clinical Research | Long Beach | California | 90807 | United States |
| Saviers Medical Group | Port Hueneme | California | 93041 | United States |
| University Clinical Investigatons, Inc/Diabetes Research Center | Tustin | California | 92780 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Colorado Springs Health Partners-Briargate | Colorado Springs | Colorado | 80922 | United States |
| Meridien Research | Bradenton | Florida | 34208 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32216 | United States |
| New Horizon Research Center, Inc. | Miami | Florida | 33175 | United States |
| International Research Assocaites, LLC | Miami | Florida | 33183 | United States |
| Harmony Clinical Research, Inc. | North Miami Beach | Florida | 33162 | United States |
| Palm Harbor Medical Associates | Palm Harbor | Florida | 34684 | United States |
| Andres Patron, D.O., P.A. | Pembroke Pines | Florida | 33026 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33603 | United States |
| Perimeter Institute for Clinical Research PRIME | Atlanta | Georgia | 30338 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Chicago Research Center | Chicago | Illinois | 60634 | United States |
| American Health Network of Indiana, LLC | Avon | Indiana | 46123 | United States |
| Medisphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| American Health Network of Indiana | Franklin | Indiana | 46131 | United States |
| American Health Network of Indiana, LLC | Muncie | Indiana | 47304 | United States |
| Bunyan Clinical Research | Valparaiso | Indiana | 46383 | United States |
| Crescent City Clinical Research Center | Metairie | Louisiana | 70006 | United States |
| Palm Research Center, Inc. | Las Vegas | Nevada | 89148 | United States |
| PMG Research of Charlotte, LLC | Charlotte | North Carolina | 28209 | United States |
| University of North Carolina at Chapel Hill | Durham | North Carolina | 27713 | United States |
| PMG Research of Salisbury, LLC | Salisbury | North Carolina | 28144 | United States |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Sentral Clinical Research Services, LLC | Cincinnati | Ohio | 45236 | United States |
| Columbus Clinical Research | Columbus | Ohio | 43213 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Lynn Institute of Norman | Norman | Oklahoma | 73069 | United States |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | United States |
| Greer | South Carolina | 29651 | United States |
| BMG The Endocrine Clinic | Memphis | Tennessee | 38119 | United States |
| Tekton Research, Inc. | Austin | Texas | 78745 | United States |
| 3rd Coast Research Associates | Corpus Christi | Texas | 78414 | United States |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | United States |
| Galena Research | Dallas | Texas | 75251 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Medstar Clinical Research and Associates | Houston | Texas | 77083 | United States |
| Clinical Trials of Texas, Inc. | San Angelo | Texas | 78229 | United States |
| Sound Healthcare | Port Orchard | Washington | 98366 | United States |
| Ranier Clinical Research Center | Renton | Washington | 98057 | United States |
| 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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