Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
| Verified date | March 2019 |
| Source | Intarcia Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
| Status | Terminated |
| Enrollment | 245 |
| Est. completion date | January 26, 2018 |
| Est. primary completion date | January 26, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of T2D 3 months prior to the Screening Visit. - Body mass index (BMI) between =25 to =45 kg/m2 at the Screening Visit. - Glycosylated hemoglobin A1c (HbA1c) =7.5 and =10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of =1500 mg/day). Exclusion Criteria: - History of type 1 diabetes. - Prior participation in a clinical study involving ITCA 650. - Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening. - History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke. - History or evidence of acute or chronic pancreatitis. - History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2. - Treatment of medications that affect GI motility. - History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients. - Women that are pregnant, lactating, or planning to become pregnant. - Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Milestone Research | London | Ontario |
| Canada | Bailey Clinic | Red Deer | Alberta |
| Canada | Bluewater Clinical Research Group | Sarnia | Ontario |
| Canada | Dr. Anil K. Gupta Medicine Professional Corporation | Toronto | Ontario |
| Canada | CookMed Research | Victoria | British Columbia |
| United States | Radiant Research | Akron | Ohio |
| United States | Albany Medical College | Albany | New York |
| United States | Anaheim Clinical Trials | Anaheim | California |
| United States | Community Hospital of Anderson and Madison County, Inc. | Anderson | Indiana |
| United States | Atlanta Center for Medical Research | Atlanta | Georgia |
| United States | Primary Care Research Group | Atlanta | Georgia |
| United States | Maine Research Associates | Auburn | Maine |
| United States | Heartland Research Associates, LLC | Augusta | Kansas |
| United States | Denver VA Medical Center | Aurora | Colorado |
| United States | DCT-AACT, LLC dba Discovery Clinical Trials | Austin | Texas |
| United States | Pennington Biomedical Research Center | Baton Rouge | Louisiana |
| United States | Ehrhardt Clinical Research, LLC | Belton | Missouri |
| United States | Joslin Diabetes Center | Boston | Massachusetts |
| United States | Mercury Street Medical Group | Butte | Montana |
| United States | Radiant Research | Carlsbad | California |
| United States | Radiant Research | Centennial | Colorado |
| United States | American Health Research | Charlotte | North Carolina |
| United States | Michigan Avenue Internists | Chicago | Illinois |
| United States | Sentral Clinical Research Services, LLC | Cincinnati | Ohio |
| United States | Ericksen Research and Development, LLC | Clinton | Utah |
| United States | Colorado Springs Health Partners - East | Colorado Springs | Colorado |
| United States | Aventiv Research | Columbus | Ohio |
| United States | Canyon Medical Center, LLC | Columbus | Ohio |
| United States | Nature Coast Clinical Reseaerch - Crystal River | Crystal River | Florida |
| United States | Dallas Diabetes and Endocrine Center | Dallas | Texas |
| United States | Research Institute of Dallas | Dallas | Texas |
| United States | Global Medical Research | DeSoto | Texas |
| United States | Radiant Research, Inc. | Edina | Minnesota |
| United States | Skyline Medical Center | Elkhorn | Nebraska |
| United States | Clinical Research Advantage | Evansville | Indiana |
| United States | Fountain Hills Family Practice, P.C. | Fountain Hills | Arizona |
| United States | American Health Network of Indiana, LLC | Franklin | Indiana |
| United States | Prestige Clinical Research | Franklin | Ohio |
| United States | Research Center of Fresno, Inc. | Fresno | California |
| United States | Thomas C. Lenzmeier, M.D., P.C. | Glendale | Arizona |
| United States | Marin Endocrine Care and Research, Inc. | Greenbrae | California |
| United States | Medication Management, LLC | Greensboro | North Carolina |
| United States | Harleysville Medical Associates | Harleysville | Pennsylvania |
| United States | HealthCare Research Network | Hazelwood | Missouri |
| United States | Nevada Family Care | Henderson | Nevada |
| United States | Indago Research and Health Center, Inc. | Hialeah | Florida |
| United States | Juno Research | Houston | Texas |
| United States | PCP for Life - -Tidwell | Houston | Texas |
| United States | National Research Institute | Huntington Park | California |
| United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
| United States | Sante Clinical Research | Kerrville | Texas |
| United States | Wells Institute for Health Awareness | Kettering | Ohio |
| United States | Holston Medical Group, P.C. | Kingsport | Tennessee |
| United States | Palm Research Center, Inc. | Las Vegas | Nevada |
| United States | Scott Research Center | Laurelton | New York |
| United States | Columbine Family Practice | Littleton | Colorado |
| United States | National Research Institute | Los Angeles | California |
| United States | Clinical Research Institute of Southern Oregon, PC | Medford | Oregon |
| United States | Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee |
| United States | Solaris Clinical Research | Meridian | Idaho |
| United States | Research Institure of South Florida | Miami | Florida |
| United States | Oklahoma City Clinic - Midwest City | Midwest City | Oklahoma |
| United States | Catalina Research Institute | Montclair | California |
| United States | Down East Medical Associates, PA | Morehead City | North Carolina |
| United States | Radiant Research | Murray | Utah |
| United States | American Health Network of Indiana, LLC | New Albany | Indiana |
| United States | Intend Research | Norman | Oklahoma |
| United States | Providence Clinical Research | North Hollywood | California |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Oklahoma City Clinic - Central | Oklahoma City | Oklahoma |
| United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
| United States | Overland Park Surgical Specialists, LLL dba College Park Family Care Center | Overland Park | Kansas |
| United States | Palm Harbor Medical Associates | Palm Harbor | Florida |
| United States | Andres Patron, D.O., P.A | Pembroke Pines | Florida |
| United States | South Broward Research | Pembroke Pines | Florida |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Central Phoenix Medical Center | Phoenix | Arizona |
| United States | Family Practice Specialists | Phoenix | Arizona |
| United States | Preferred Primary Care Phys Inc | Pittsburgh | Pennsylvania |
| United States | Sound Healthcare | Port Orchard | Washington |
| United States | Clinical Research of Rock Hill | Rock Hill | South Carolina |
| United States | Center for Clinical Trials of Sacramento, Inc. | Sacramento | California |
| United States | Health Texas Research Institute | San Angelo | Texas |
| United States | Clinical Trials of Texas, Inc. | San Antonio | Texas |
| United States | MacGregor Medical Center | San Antonio | Texas |
| United States | Panacea Clinical Research | San Antonio | Texas |
| United States | Victorium Clinical Research Ltd. | San Antonio | Texas |
| United States | Medical and Procedural Specialists | Skokie | Illinois |
| United States | Spartanburg Medical Research | Spartanburg | South Carolina |
| United States | HSHS Medical Group DIabetes Research | Springfield | Illinois |
| United States | Fiel Family and Sports Medicine | Tempe | Arizona |
| United States | University of Toledo | Toledo | Ohio |
| United States | Cotton O'Neil Clinical Research Center | Topeka | Kansas |
| United States | Arizona Community Physicians | Tucson | Arizona |
| United States | Orange Grove Family Practice | Tucson | Arizona |
| United States | Preferred Primary Care Physicians | Uniontown | Pennsylvania |
| United States | Crossroads Clinical Research, LLC | Victoria | Texas |
| United States | Advanced Clinical Research | West Jordan | Utah |
| United States | Heartland Research Associates, LLC | Wichita | Kansas |
| United States | Heartland Research Associates, LLC | Wichita | Kansas |
| United States | PMG Research of Wilmington, LLC | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Intarcia Therapeutics |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction in glycosylated hemoglobin A1c | To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up. | Randomization to 69 weeks | |
| Primary | Reduction in weight | To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up. | Randomization to 69 weeks |
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