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

March 4, 2019 updated by: Intarcia Therapeutics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T466V7
        • Bailey Clinic
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 4A1
        • CookMed Research
    • Ontario
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr. Anil K. Gupta Medicine Professional Corporation
  • United States
    • Arizona
      • Fountain Hills, Arizona, United States, 85268
        • Fountain Hills Family Practice, P.C.
      • Glendale, Arizona, United States, 85308
        • Thomas C. Lenzmeier, M.D., P.C.
      • Phoenix, Arizona, United States, 85018
        • Family Practice Specialists
      • Phoenix, Arizona, United States, 85020
        • Central Phoenix Medical Center
      • Tempe, Arizona, United States, 85283
        • Fiel Family and Sports Medicine
      • Tucson, Arizona, United States, 85712
        • Arizona Community Physicians
      • Tucson, Arizona, United States, 85741
        • Orange Grove Family Practice
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • Carlsbad, California, United States, 92008
        • Radiant Research
      • Fresno, California, United States, 93726
        • Research Center of Fresno, Inc.
      • Greenbrae, California, United States, 94904
        • Marin Endocrine Care And Research, Inc.
      • Huntington Park, California, United States, 90255
        • National Research Institute
      • Los Angeles, California, United States, 91402
        • National Research Institute
      • Montclair, California, United States, 91710
        • Catalina Research Institute
      • North Hollywood, California, United States, 91606
        • Providence Clinical Research
      • Sacramento, California, United States, 95816
        • Center for Clinical Trials of Sacramento, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Denver VA Medical Center
      • Centennial, Colorado, United States, 75115
        • Radiant Research
      • Colorado Springs, Colorado, United States, 80922
        • Colorado Springs Health Partners - East
      • Littleton, Colorado, United States, 80128
        • Columbine Family Practice
    • Florida
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Reseaerch - Crystal River
      • Hialeah, Florida, United States, 33012
        • Indago Research and Health Center, Inc.
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Miami, Florida, United States, 33173
        • Research Institure of South Florida
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Palm Harbor, Florida, United States, 34684
        • Palm Harbor Medical Associates
      • Pembroke Pines, Florida, United States, 33027
        • South Broward Research
      • Pembroke Pines, Florida, United States, 33026
        • Andres Patron, D.O., P.A
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30312
        • Primary Care Research Group
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60604
        • Michigan Avenue Internists
      • Skokie, Illinois, United States, 60077
        • Medical and Procedural Specialists
      • Springfield, Illinois, United States, 62711
        • HSHS Medical Group Diabetes Research
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Community Hospital of Anderson and Madison County, Inc.
      • Evansville, Indiana, United States, 47225
        • Clinical Research Advantage
      • Franklin, Indiana, United States, 46131
        • American Health Network of Indiana, LLC
      • New Albany, Indiana, United States, 47150
        • American Health Network of Indiana, LLC
    • Kansas
      • Augusta, Kansas, United States, 67010
        • Heartland Research Associates, LLC
      • Overland Park, Kansas, United States, 66210
        • Overland Park Surgical Specialists, LLL dba College Park Family Care Center
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
      • Wichita, Kansas, United States, 67205
        • Heartland Research Associates, LLC
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Radiant Research, Inc.
    • Missouri
      • Belton, Missouri, United States, 64012
        • Ehrhardt Clinical Research, LLC
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Skyline Medical Center
    • Nevada
      • Henderson, Nevada, United States, 89047
        • Nevada Family Care
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center, Inc.
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Laurelton, New York, United States, 11413
        • Scott Research Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • American Health Research
      • Greensboro, North Carolina, United States, 27408
        • Medication Management, LLC
      • Morehead City, North Carolina, United States, 28557
        • Down East Medical Associates, PA
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Akron, Ohio, United States, 44311
        • Radiant Research
      • Cincinnati, Ohio, United States, 45236
        • Sentral Clinical Research Services, LLC
      • Columbus, Ohio, United States, 43213
        • Canyon Medical Center, LLC
      • Columbus, Ohio, United States, 43231
        • Aventiv Research
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
      • Kettering, Ohio, United States, 45429
        • Wells Institute for Health Awareness
      • Toledo, Ohio, United States, 43614
        • University of Toledo
    • Oklahoma
      • Midwest City, Oklahoma, United States, 73110
        • Oklahoma City Clinic - Midwest City
      • Norman, Oklahoma, United States, 73069
        • Intend Research
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma City Clinic - Central
    • Oregon
      • Medford, Oregon, United States, 97504
        • Clinical Research Institute of Southern Oregon, PC
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Harleysville Medical Associates
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15243
        • Preferred Primary Care Phys Inc
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Clinical Research of Rock Hill
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group, P.C.
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Austin, Texas, United States, 78758
        • DCT-AACT, LLC dba Discovery Clinical Trials
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes and Endocrine Center
      • Dallas, Texas, United States, 75231
        • Research Institute Of Dallas
      • DeSoto, Texas, United States, 75115
        • Global Medical Research
      • Houston, Texas, United States, 77004
        • Juno Research
      • Houston, Texas, United States, 77093
        • PCP for Life - -Tidwell
      • Kerrville, Texas, United States, 78028
        • Sante Clinical Research
      • San Angelo, Texas, United States, 78228
        • Health Texas Research Institute
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, United States, 78228
        • Panacea Clinical Research
      • San Antonio, Texas, United States, 78240
        • MacGregor Medical Center
      • San Antonio, Texas, United States, 78230
        • Victorium Clinical Research Ltd.
      • Victoria, Texas, United States, 77901
        • Crossroads Clinical Research, LLC
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research and Development, LLC
      • Murray, Utah, United States, 84123
        • Radiant Research
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Sound Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental: Group 1
ITCA 650 20/60 mcg/day
Drug: ITCA 650 20/60 mcg/day
ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
EXPERIMENTAL: Experimental: Group 2
Empagliflozin 10 mg/day and 25 mg/day
Drug: Empagliflozin (oral)
10 mg/day and 25 mg/day
EXPERIMENTAL: Experimental: Group 3
Glimepiride 1-6 mg/day
Drug: Glimepiride (oral)
1-6 mg/day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction in glycosylated hemoglobin A1c
Time Frame: Randomization to 69 weeks
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
Time Frame: Randomization to 69 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intarcia Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITCA 650-CLP-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

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Dietary Supplements

Sponsor/Collaborators

Locations

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