Clinical Trial Details

NCT ID: NCT03060980
Date Last Changed: October 4, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of ITCA 650 20/60 mcg/day, Empagliflozin (oral) and Glimepiride (oral) to evaluate Diabetes Mellitus, Type 2

Research Study 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

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Intarcia Therapeutics
Duration
33 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 80 Years

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.

Site Locations (86)

Country State City Zip Facility and Contact
United States Arizona Fountain Hills 85268 Fountain Hills Family Practice, P.C.
United States Arizona Glendale 85308 Thomas C. Lenzmeier, M.D., P.C.
United States Arizona Phoenix 85018 Family Practice Specialists
United States Arizona Phoenix 85020 Central Phoenix Medical Center
United States Arizona Tempe 85283 Fiel Family and Sports Medicine
United States Arizona Tucson 85712 Arizona Community Physicians
United States Arizona Tucson 85741 Orange Grove Family Practice
United States California Anaheim 92801 Anaheim Clinical Trials
United States California Carlsbad 92008 Radiant Research
United States California Fresno 93726 Research Center of Fresno, Inc.
United States California Greenbrae 94904 Marin Endocrine Care and Research, Inc.
United States California Huntington Park 90255 National Research Institute
United States California Los Angeles 91402 National Research Institute
United States California Montclair 91710 Catalina Research Institute
United States California North Hollywood 91606 Providence Clinical Research
United States California Sacramento 95816 Center for Clinical Trials of Sacramento, Inc.
United States Colorado Aurora 80045 Denver VA Medical Center
United States Colorado Colorado Springs 80922 Colorado Springs Health Partners - East
United States Colorado Littleton 80128 Columbine Family Practice
United States Florida Crystal River 34429 Nature Coast Clinical Reseaerch - Crystal River
United States Florida Hialeah 33012 Indago Research and Health Center, Inc.
United States Florida Jacksonville 32256 Clinical Neuroscience Solutions, Inc.
United States Florida Orlando 32801 Clinical Neuroscience Solutions, Inc.
United States Florida Palm Harbor 34684 Palm Harbor Medical Associates
United States Florida Pembroke Pines 33026 Andres Patron, D.O., P.A
United States Florida Pembroke Pines 33027 South Broward Research
United States Georgia Atlanta 30331 Atlanta Center for Medical Research
United States Idaho Meridian 83646 Solaris Clinical Research
United States Illinois Chicago 60604 Michigan Avenue Internists
United States Illinois Springfield 62711 HSHS Medical Group DIabetes Research
United States Indiana Anderson 46011 Community Hospital of Anderson and Madison County, Inc.
United States Indiana Evansville 47225 Clinical Research Advantage
United States Indiana Franklin 46131 American Health Network of Indiana, LLC
United States Indiana New Albany 47150 American Health Network of Indiana, LLC
United States Kansas Augusta 67010 Heartland Research Associates, LLC
United States Kansas Topeka 66606 Cotton O'Neil Clinical Research Center
United States Kansas Wichita 67205 Heartland Research Associates, LLC
United States Kansas Wichita 67207 Heartland Research Associates, LLC
United States Maine Auburn 04210 Maine Research Associates
United States Minnesota Edina 55435 Radiant Research, Inc.
United States Missouri Belton 64012 Ehrhardt Clinical Research, LLC
United States Missouri Hazelwood 63042 HealthCare Research Network
United States Montana Butte 59701 Mercury Street Medical Group
United States Nebraska Elkhorn 68022 Skyline Medical Center
United States Nevada Henderson 89047 Nevada Family Care
United States Nevada Las Vegas 89148 Palm Research Center, Inc.
United States New York Albany 12208 Albany Medical College
United States New York Laurelton 11413 Scott Research Center
United States North Carolina Greensboro 27408 Medication Management, LLC
United States North Carolina Morehead City 28557 Down East Medical Associates, PA
United States North Carolina Wilmington 28401 PMG Research of Wilmington, LLC
United States Ohio Akron 44311 Radiant Research
United States Ohio Cincinnati 45236 Sentral Clinical Research Services, LLC
United States Ohio Columbus 43213 Canyon Medical Center, LLC
United States Ohio Columbus 43231 Aventiv Research
United States Ohio Franklin 45005 Prestige Clinical Research
United States Ohio Kettering 45429 Wells Institute for Health Awareness
United States Oklahoma Midwest City 73110 Oklahoma City Clinic - Midwest City
United States Oklahoma Norman 73069 Intend Research
United States Oklahoma Oklahoma City 73104 Oklahoma City Clinic - Central
United States Oklahoma Oklahoma City 73112 Lynn Health Science Institute
United States Oregon Medford 97504 Clinical Research Institute of Southern Oregon, PC
United States Pennsylvania Harleysville 19438 Harleysville Medical Associates
United States Pennsylvania Pittsburgh 15243 Preferred Primary Care Phys Inc
United States Pennsylvania Uniontown 15401 Preferred Primary Care Physicians
United States South Carolina Rock Hill 29732 Clinical Research of Rock Hill
United States South Carolina Spartanburg 29303 Spartanburg Medical Research
United States Tennessee Kingsport 37660 Holston Medical Group, P.C.
United States Tennessee Memphis 38119 Clinical Neuroscience Solutions, Inc.
United States Texas Austin 78758 DCT-AACT, LLC dba Discovery Clinical Trials
United States Texas Dallas 75230 Dallas Diabetes and Endocrine Center
United States Texas Dallas 75231 Research Institute of Dallas
United States Texas DeSoto 75115 Global Medical Research
United States Texas Houston 77004 Juno Research
United States Texas Houston 77093 PCP for Life - -Tidwell
United States Texas Kerrville 78028 Sante Clinical Research
United States Texas San Angelo 78228 Health Texas Research Institute
United States Texas San Antonio 78228 Panacea Clinical Research
United States Texas San Antonio 78229 Clinical Trials of Texas, Inc.
United States Texas San Antonio 78230 Victorium Clinical Research Ltd.
United States Texas Victoria 77901 Crossroads Clinical Research, LLC
United States Utah Clinton 84015 Ericksen Research and Development, LLC
United States Utah Murray 84123 Radiant Research
United States Utah West Jordan 84088 Advanced Clinical Research
United States Washington Port Orchard 98366 Sound Healthcare
Canada Alberta Red Deer T466V7 Bailey Clinic

Contact

Michelle Baron, MD, FACE
617-936-2500
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.