Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

NCT03060980 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: ITCA 650-CLP-203
• Study Type: interventional
• Target: 245
• Locations: 2 countries
• Sites: 101

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Experimental: Group 1

EXPERIMENTAL

ITCA 650 20/60 mcg/day

Drug: ITCA 650 20/60 mcg/day

Experimental: Group 2

EXPERIMENTAL

Empagliflozin 10 mg/day and 25 mg/day

Drug: Empagliflozin (oral)

Experimental: Group 3

EXPERIMENTAL

Glimepiride 1-6 mg/day

Drug: Glimepiride (oral)

Interventions

ITCA 650 20/60 mcg/day DRUG

ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day

Experimental: Group 1

Empagliflozin (oral) DRUG

10 mg/day and 25 mg/day

Experimental: Group 2

Glimepiride (oral) DRUG

1-6 mg/day

Experimental: Group 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intarcia Therapeutics: lead

Study Sites (101)

Fountain Hills Family Practice, P.C.

Fountain Hills, Arizona, 85268, United States

Location

Thomas C. Lenzmeier, M.D., P.C.

Glendale, Arizona, 85308, United States

Location

Family Practice Specialists

Phoenix, Arizona, 85018, United States

Location

Central Phoenix Medical Center

Phoenix, Arizona, 85020, United States

Location

Fiel Family and Sports Medicine

Tempe, Arizona, 85283, United States

Location

Arizona Community Physicians

Tucson, Arizona, 85712, United States

Location

Orange Grove Family Practice

Tucson, Arizona, 85741, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Radiant Research

Carlsbad, California, 92008, United States

Location

Research Center of Fresno, Inc.

Fresno, California, 93726, United States

Location

Marin Endocrine Care and Research, Inc.

Greenbrae, California, 94904, United States

Location

National Research Institute

Huntington Park, California, 90255, United States

Location

National Research Institute

Los Angeles, California, 91402, United States

Location

Catalina Research Institute

Montclair, California, 91710, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Center for Clinical Trials of Sacramento, Inc.

Sacramento, California, 95816, United States

Location

Denver VA Medical Center

Aurora, Colorado, 80045, United States

Location

Radiant Research

Centennial, Colorado, 75115, United States

Location

Colorado Springs Health Partners - East

Colorado Springs, Colorado, 80922, United States

Location

Columbine Family Practice

Littleton, Colorado, 80128, United States

Location

Nature Coast Clinical Reseaerch - Crystal River

Crystal River, Florida, 34429, United States

Location

Indago Research and Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Research Institure of South Florida

Miami, Florida, 33173, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Palm Harbor Medical Associates

Palm Harbor, Florida, 34684, United States

Location

Andres Patron, D.O., P.A

Pembroke Pines, Florida, 33026, United States

Location

South Broward Research

Pembroke Pines, Florida, 33027, United States

Location

Primary Care Research Group

Atlanta, Georgia, 30312, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Michigan Avenue Internists

Chicago, Illinois, 60604, United States

Location

Medical and Procedural Specialists

Skokie, Illinois, 60077, United States

Location

HSHS Medical Group DIabetes Research

Springfield, Illinois, 62711, United States

Location

Community Hospital of Anderson and Madison County, Inc.

Anderson, Indiana, 46011, United States

Location

Clinical Research Advantage

Evansville, Indiana, 47225, United States

Location

American Health Network of Indiana, LLC

Franklin, Indiana, 46131, United States

Location

American Health Network of Indiana, LLC

New Albany, Indiana, 47150, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States

Location

Overland Park Surgical Specialists, LLL dba College Park Family Care Center

Overland Park, Kansas, 66210, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Maine Research Associates

Auburn, Maine, 04210, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Radiant Research, Inc.

Edina, Minnesota, 55435, United States

Location

Ehrhardt Clinical Research, LLC

Belton, Missouri, 64012, United States

Location

HealthCare Research Network

Hazelwood, Missouri, 63042, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

Skyline Medical Center

Elkhorn, Nebraska, 68022, United States

Location

Nevada Family Care

Henderson, Nevada, 89047, United States

Location

Palm Research Center, Inc.

Las Vegas, Nevada, 89148, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Scott Research Center

Laurelton, New York, 11413, United States

Location

American Health Research

Charlotte, North Carolina, 28207, United States

Location

Medication Management, LLC

Greensboro, North Carolina, 27408, United States

Location

Down East Medical Associates, PA

Morehead City, North Carolina, 28557, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Radiant Research

Akron, Ohio, 44311, United States

Location

Sentral Clinical Research Services, LLC

Cincinnati, Ohio, 45236, United States

Location

Canyon Medical Center, LLC

Columbus, Ohio, 43213, United States

Location

Aventiv Research

Columbus, Ohio, 43231, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

Wells Institute for Health Awareness

Kettering, Ohio, 45429, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Oklahoma City Clinic - Midwest City

Midwest City, Oklahoma, 73110, United States

Location

Intend Research

Norman, Oklahoma, 73069, United States

Location

Oklahoma City Clinic - Central

Oklahoma City, Oklahoma, 73104, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Harleysville Medical Associates

Harleysville, Pennsylvania, 19438, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Preferred Primary Care Phys Inc

Pittsburgh, Pennsylvania, 15243, United States

Location

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Holston Medical Group, P.C.

Kingsport, Tennessee, 37660, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

DCT-AACT, LLC dba Discovery Clinical Trials

Austin, Texas, 78758, United States

Location

Dallas Diabetes and Endocrine Center

Dallas, Texas, 75230, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Global Medical Research

DeSoto, Texas, 75115, United States

Location

Juno Research

Houston, Texas, 77004, United States

Location

PCP for Life - -Tidwell

Houston, Texas, 77093, United States

Location

Sante Clinical Research

Kerrville, Texas, 78028, United States

Location

Health Texas Research Institute

San Angelo, Texas, 78228, United States

Location

Panacea Clinical Research

San Antonio, Texas, 78228, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Victorium Clinical Research Ltd.

San Antonio, Texas, 78230, United States

Location

MacGregor Medical Center

San Antonio, Texas, 78240, United States

Location

Crossroads Clinical Research, LLC

Victoria, Texas, 77901, United States

Location

Ericksen Research and Development, LLC

Clinton, Utah, 84015, United States

Location

Radiant Research

Murray, Utah, 84123, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Sound Healthcare

Port Orchard, Washington, 98366, United States

Location

Bailey Clinic

Red Deer, Alberta, T466V7, Canada

Location

CookMed Research

Victoria, British Columbia, V8V 4A1, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

Bluewater Clinical Research Group

Sarnia, Ontario, N7T 4X3, Canada

Location

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, M9V 4B4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide; empagliflozin; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 23, 2017
• Study Start: March 3, 2017
• Primary Completion: January 26, 2018
• Study Completion: January 26, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); US (96)