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Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITCA 650 40 mcg/day | Experimental |
| |
| ITCA 650 60 mcg/day | Experimental |
| |
| ITCA placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITCA 650 | Drug | ITCA 650 is exenatide in DUROS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 39-week Treatment Period | 39 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Birmingham | Alabama | 35235 | United States | ||
| Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29242349 | Derived | Rosenstock J, Buse JB, Azeem R, Prabhakar P, Kjems L, Huang H, Baron MA. Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial. Diabetes Care. 2018 Feb;41(2):333-340. doi: 10.2337/dc17-1306. Epub 2017 Dec 14. |
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| ITCA placebo |
| Other |
Formulation in DUROS (no exenatide) |
|
| Gulf Shores |
| Alabama |
| 36542 |
| United States |
| Study Site | Huntsville | Alabama | 35801 | United States |
| Study Site | Chandler | Arizona | 85224 | United States |
| Study Site | Goodyear | Arizona | 85395 | United States |
| Study Site | Phoenix | Arizona | 85020 | United States |
| Study Site | Little Rock | Arkansas | 72205 | United States |
| Study Site | Chula Vista | California | 91911 | United States |
| Study Site | Fresno | California | 93721 | United States |
| Intarcia | Hayward | California | 94545 | United States |
| Study Site | Long Beach | California | 90806 | United States |
| Study Site | Los Angeles | California | 90017 | United States |
| Study Site | National City | California | 91950 | United States |
| Study Site | Port Hueneme | California | 93041 | United States |
| Study Site | San Jose | California | 95123 | United States |
| Study Site | San Mateo | California | 94401 | United States |
| Study Site | Tustin | California | 92780 | United States |
| Study Site | Valley Village | California | 91607 | United States |
| Study Site | Walnut Creek | California | 94598 | United States |
| Study Site | Watsonville | California | 95076 | United States |
| Study Site | Colorado Springs | Colorado | 80907 | United States |
| Study Site | Colorado Springs | Colorado | 80922 | United States |
| Study Site | Boca Raton | Florida | 33432 | United States |
| Study Site | Bradenton | Florida | 34208 | United States |
| Study Site | Celebration | Florida | 34747 | United States |
| Study Site | Clearwater | Florida | 33765 | United States |
| Study Site | Coral Gables | Florida | 33134 | United States |
| Study Site | Daytona Beach | Florida | 32117 | United States |
| Study Site | Hollywood | Florida | 33021 | United States |
| Study Site | Jacksonville | Florida | 32205 | United States |
| Study Site | Jacksonville | Florida | 32216 | United States |
| Study Site | Jacksonville | Florida | 32258 | United States |
| Study Site | Miami | Florida | 33126 | United States |
| Study Site | Miami | Florida | 33135 | United States |
| Study Site | Miami | Florida | 33145 | United States |
| Study Site | Miami | Florida | 33175 | United States |
| Study Site | Miami | Florida | 33183 | United States |
| Study Site | New Port Richey | Florida | 34652 | United States |
| Study Site | North Miami Beach | Florida | 33162 | United States |
| Study Site | Orlando | Florida | 32806 | United States |
| Study Site | Palm Harbor | Florida | 34684 | United States |
| Study Site | Pembroke Pines | Florida | 33026 | United States |
| Study Site | Ponte Vedra | Florida | 32081 | United States |
| Study Site | Tampa | Florida | 33603 | United States |
| Study Site | Atlanta | Georgia | 30338 | United States |
| Study Site | Canton | Georgia | 30114 | United States |
| Study Site | Idaho Falls | Idaho | 83404 | United States |
| Study Site | Meridian | Idaho | 83646 | United States |
| Study Site | Chicago | Illinois | 60607 | United States |
| Study Site | Chicago | Illinois | 60634 | United States |
| Study Site | Chicago | Illinois | 75251 | United States |
| Study Site | Evansville | Illinois | 47714 | United States |
| Study Site | Avon | Indiana | 46123 | United States |
| Study Site | Evansville | Indiana | 47714 | United States |
| Study Site | Franklin | Indiana | 46131 | United States |
| Study Site | Greenfield | Indiana | 46140 | United States |
| Study Site | Muncie | Indiana | 47304 | United States |
| Study Site | Valparaiso | Indiana | 46383 | United States |
| Study Site | Des Moines | Iowa | 50314 | United States |
| Study Site | Newton | Kansas | 67114 | United States |
| Study Site | Metaire | Louisiana | 70006 | United States |
| Study Site | Metairie | Louisiana | 70006 | United States |
| Study Site | Metarie | Louisiana | 70006 | United States |
| Study Site | New Orleans | Louisiana | 70119 | United States |
| Study Site | Baltimore | Maryland | 21204 | United States |
| Study Site | Brockton | Massachusetts | 02301 | United States |
| Study Site | Rochester | Michigan | 48307 | United States |
| Study Site | Ypsilanti | Michigan | 48197 | United States |
| Study Site | Kansas City | Missouri | 64111 | United States |
| Study Site | Billings | Montana | 59101 | United States |
| Study Site | Lincoln | Nebraska | 68510 | United States |
| Study Site | Las Vegas | Nevada | 89148 | United States |
| Study Site | Toms River | New Jersey | 08753 | United States |
| Study Site | Brooklyn | New York | 11218 | United States |
| Study Site | Endwell | New York | 13760 | United States |
| Study Site | Staten Island | New York | 10301 | United States |
| Study Site | Charlotte | North Carolina | 28209 | United States |
| Study Site | Charlotte | North Carolina | 28210 | United States |
| Study Site | Durham | North Carolina | 27713 | United States |
| Study Site | Greensboro | North Carolina | 27401 | United States |
| Study Site | Hickory | North Carolina | 28602 | United States |
| Study Site | Moorehead City | North Carolina | 28557 | United States |
| Study Site | Mooresville | North Carolina | 28117 | United States |
| Study Site | Salisbury | North Carolina | 28144 | United States |
| Study Site | Wilmington | North Carolina | 28401 | United States |
| Study Site | Winston-Salem | North Carolina | 27103 | United States |
| Study Site | Cincinnati | Ohio | 45236 | United States |
| Study Site | Cincinnati | Ohio | 45242 | United States |
| Study Site | Columbus | Ohio | 43213 | United States |
| Study Site | Franklin | Ohio | 45005 | United States |
| Study Site | Toledo | Ohio | 43623 | United States |
| Study Site | Norman | Oklahoma | 73069 | United States |
| Study Site | Oklahoma City | Oklahoma | 73112 | United States |
| Study Site | Bend | Oregon | 97701 | United States |
| Study Site | Uniontown | Pennsylvania | 15401 | United States |
| Study Site | Greer | South Carolina | 29651 | United States |
| Study Site | North Myrtle Beach | South Carolina | 29582 | United States |
| Study Site | Dakota Dunes | South Dakota | 57049 | United States |
| Study Site | Knoxville | Tennessee | 37920 | United States |
| Study Site | Memphis | Tennessee | 38119 | United States |
| Study Site | Austin | Texas | 78731 | United States |
| Study Site | Austin | Texas | 78745 | United States |
| Study Site | Carrolton | Texas | 75007 | United States |
| Study Site | Corpus Cristi | Texas | 78414 | United States |
| Study Site | Dallas | Texas | 75230 | United States |
| Study Site | Dallas | Texas | 75251 | United States |
| Study Site | Fort Worth | Texas | 76135 | United States |
| Study Site | Houston | Texas | 77057 | United States |
| Study Site | Houston | Texas | 77083 | United States |
| Study Site | Houston | Texas | 77095 | United States |
| Study Site | San Angelo | Texas | 76904 | United States |
| Study Site | San Antonio | Texas | 78228 | United States |
| Study Site | San Antonio | Texas | 78229 | United States |
| Study Site | Sugar Land | Texas | 77478 | United States |
| Study Site | Tomball | Texas | 77375 | United States |
| Study Site | Danville | Virginia | 24541 | United States |
| Study Site | Norfolk | Virginia | 23510 | United States |
| Study Site | Richmond | Virginia | 23219 | United States |
| Study Site | Port Orchard | Washington | 98336 | United States |
| Study Site | Renton | Washington | 98057 | United States |
| Study Site | Spokane | Washington | 99202 | 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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