Type 2 Diabetes Clinical Trial
Official title:
An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c
| Verified date | March 2019 |
| Source | Intarcia Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day
| Status | Terminated |
| Enrollment | 100 |
| Est. completion date | January 2018 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Men or women age 18 to 80 years with type 2 diabetes - On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs - HbA1c >10.0% and =12.0% Exclusion Criteria: - Prior treatment with any GLP-1 receptor agonist - History of hypersensitivity to exenatide or liraglutide - FPG >300 mg/dL - History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2 - Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months - history of pancreatitis |
| Country | Name | City | State |
|---|---|---|---|
| United States | Perimeter Institute for Clinical Research PRIME | Atlanta | Georgia |
| United States | Tekton Research, Inc. | Austin | Texas |
| United States | American Health Network of Indiana, LLC | Avon | Indiana |
| United States | Alabama Clinical Therapeutics, LLC | Birmingham | Alabama |
| United States | Meridien Research | Bradenton | Florida |
| United States | East Valley Family Physicians, PLC | Chandler | Arizona |
| United States | PMG Research of Charlotte, LLC | Charlotte | North Carolina |
| United States | Chicago Research Center | Chicago | Illinois |
| United States | eStudySite | Chula Vista | California |
| United States | Sentral Clinical Research Services, LLC | Cincinnati | Ohio |
| United States | Colorado Springs Health Partners-Briargate | Colorado Springs | Colorado |
| United States | Columbus Clinical Research | Columbus | Ohio |
| United States | 3rd Coast Research Associates | Corpus Christi | Texas |
| United States | Dallas Diabetes and Endocrine Center | Dallas | Texas |
| United States | Galena Research | Dallas | Texas |
| United States | University of Texas Southwestern Medical Center | Dallas | Texas |
| United States | University of North Carolina at Chapel Hill | Durham | North Carolina |
| United States | Medisphere Medical Research Center, LLC | Evansville | Indiana |
| United States | American Health Network of Indiana | Franklin | Indiana |
| United States | Prestige Clinical Research | Franklin | Ohio |
| United States | Rocks Medical Research Institute | Fresno | California |
| United States | Rocks Medical Research Institute, Inc. | Fresno | California |
| United States | Fundamental Research | Gulf Shores | Alabama |
| United States | Medstar Clinical Research and Associates | Houston | Texas |
| United States | East Coast Institute for Research, LLC | Jacksonville | Florida |
| United States | Palm Research Center, Inc. | Las Vegas | Nevada |
| United States | Long Beach Center for Clinical Research | Long Beach | California |
| United States | BMG The Endocrine Clinic | Memphis | Tennessee |
| United States | Solaris Clinical Research | Meridian | Idaho |
| United States | Desert Clinical Research | Mesa | Arizona |
| United States | Crescent City Clinical Research Center | Metairie | Louisiana |
| United States | International Research Assocaites, LLC | Miami | Florida |
| United States | New Horizon Research Center, Inc. | Miami | Florida |
| United States | American Health Network of Indiana, LLC | Muncie | Indiana |
| United States | Lynn Institute of Norman | Norman | Oklahoma |
| United States | Harmony Clinical Research, Inc. | North Miami Beach | Florida |
| United States | Palm Harbor Medical Associates | Palm Harbor | Florida |
| United States | Andres Patron, D.O., P.A. | Pembroke Pines | Florida |
| United States | Clinical Research Advantage, Inc. | Phoenix | Arizona |
| United States | Saviers Medical Group | Port Hueneme | California |
| United States | Sound Healthcare | Port Orchard | Washington |
| United States | Ranier Clinical Research Center | Renton | Washington |
| United States | PMG Research of Salisbury, LLC | Salisbury | North Carolina |
| United States | Clinical Trials of Texas, Inc. | San Angelo | Texas |
| United States | Clinical Research of West Florida | Tampa | Florida |
| United States | University Clinical Investigatons, Inc/Diabetes Research Center | Tustin | California |
| United States | Preferred Primary Care Physicians | Uniontown | Pennsylvania |
| United States | Bunyan Clinical Research | Valparaiso | Indiana |
| United States | Diablo Clinical Research, Inc. | Walnut Creek | California |
| United States | PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Intarcia Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in HbA1c between Week 39 and Day 0 | 39 weeks |
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