Clinical trial NCT03060980: Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in glycosylated hemoglobin A1c
timeFrame: Randomization to 69 weeks
measure: Reduction in weight
timeFrame: Randomization to 69 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Hills
country: United States
facility: Fountain Hills Family Practice, P.C.
state: Arizona
city: Glendale
country: United States
facility: Thomas C. Lenzmeier, M.D., P.C.
state: Arizona
city: Phoenix
country: United States
facility: Family Practice Specialists
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Center
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine
state: Arizona
city: Tucson
country: United States
facility: Arizona Community Physicians
state: Arizona
city: Tucson
country: United States
facility: Orange Grove Family Practice
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Carlsbad
country: United States
facility: Radiant Research
state: California
city: Fresno
country: United States
facility: Research Center of Fresno, Inc.
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Care and Research, Inc.
state: California
city: Huntington Park
country: United States
facility: National Research Institute
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Montclair
country: United States
facility: Catalina Research Institute
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: Sacramento
country: United States
facility: Center for Clinical Trials of Sacramento, Inc.
state: California
city: Aurora
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Centennial
country: United States
facility: Radiant Research
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Health Partners - East
state: Colorado
city: Littleton
country: United States
facility: Columbine Family Practice
state: Colorado
city: Crystal River
country: United States
facility: Nature Coast Clinical Reseaerch - Crystal River
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: Research Institure of South Florida
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Palm Harbor
country: United States
facility: Palm Harbor Medical Associates
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron, D.O., P.A
state: Florida
city: Pembroke Pines
country: United States
facility: South Broward Research
state: Florida
city: Atlanta
country: United States
facility: Primary Care Research Group
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Michigan Avenue Internists
state: Illinois
city: Skokie
country: United States
facility: Medical and Procedural Specialists
state: Illinois
city: Springfield
country: United States
facility: HSHS Medical Group DIabetes Research
state: Illinois
city: Anderson
country: United States
facility: Community Hospital of Anderson and Madison County, Inc.
state: Indiana
city: Evansville
country: United States
facility: Clinical Research Advantage
state: Indiana
city: Franklin
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: New Albany
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Surgical Specialists, LLL dba College Park Family Care Center
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: Belton
country: United States
facility: Ehrhardt Clinical Research, LLC
state: Missouri
city: Hazelwood
country: United States
facility: HealthCare Research Network
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: Elkhorn
country: United States
facility: Skyline Medical Center
state: Nebraska
city: Henderson
country: United States
facility: Nevada Family Care
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center, Inc.
state: Nevada
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Laurelton
country: United States
facility: Scott Research Center
state: New York
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Morehead City
country: United States
facility: Down East Medical Associates, PA
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services, LLC
state: Ohio
city: Columbus
country: United States
facility: Canyon Medical Center, LLC
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Midwest City
country: United States
facility: Oklahoma City Clinic - Midwest City
state: Oklahoma
city: Norman
country: United States
facility: Intend Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma City Clinic - Central
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Harleysville
country: United States
facility: Harleysville Medical Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Phys Inc
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group, P.C.
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: DCT-AACT, LLC dba Discovery Clinical Trials
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: DeSoto
country: United States
facility: Global Medical Research
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: PCP for Life - -Tidwell
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: San Angelo
country: United States
facility: Health Texas Research Institute
state: Texas
city: San Antonio
country: United States
facility: Panacea Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Victorium Clinical Research Ltd.
state: Texas
city: San Antonio
country: United States
facility: MacGregor Medical Center
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research, LLC
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development, LLC
state: Utah
city: Murray
country: United States
facility: Radiant Research
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Port Orchard
country: United States
facility: Sound Healthcare
state: Washington
city: Red Deer
country: Canada
facility: Bailey Clinic
state: Alberta
city: Victoria
country: Canada
facility: CookMed Research
state: British Columbia
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K. Gupta Medicine Professional Corporation
state: Ontario
Study officials:
References: