A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

March 4, 2019 updated by: Intarcia Therapeutics

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • 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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics, LLC
      • Gulf Shores, Alabama, United States, 36542
        • Fundamental Research
    • Arizona
      • Chandler, Arizona, United States, 85224
        • East Valley Family Physicians, PLC
      • Mesa, Arizona, United States, 85213
        • Desert Clinical Research
      • Phoenix, Arizona, United States, 85020
        • Clinical Research Advantage, Inc.
    • California
      • Chula Vista, California, United States
        • eStudySite
      • Fresno, California, United States, 93721
        • Rocks Medical Research Institute, Inc.
      • Fresno, California, United States, 93721
        • Rocks Medical Research Institute
      • Long Beach, California, United States, 90807
        • Long Beach Center For Clinical Research
      • Port Hueneme, California, United States, 93041
        • Saviers Medical Group
      • Tustin, California, United States, 92780
        • University Clinical Investigatons, Inc/Diabetes Research Center
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Colorado
      • Colorado Springs, Colorado, United States, 80922
        • Colorado Springs Health Partners-Briargate
    • Florida
      • Bradenton, Florida, United States, 34208
        • Meridien Research
      • Jacksonville, Florida, United States, 32216
        • East Coast Institute for Research, LLC
      • Miami, Florida, United States, 33175
        • New Horizon Research Center, Inc.
      • Miami, Florida, United States, 33183
        • International Research Assocaites, LLC
      • North Miami Beach, Florida, United States, 33162
        • Harmony Clinical Research, Inc.
      • Palm Harbor, Florida, United States, 34684
        • Palm Harbor Medical Associates
      • Pembroke Pines, Florida, United States, 33026
        • Andres Patron, D.O., P.A.
      • Tampa, Florida, United States, 33603
        • Clinical Research of West Florida
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Perimeter Institute for Clinical Research PRIME
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Chicago Research Center
    • Indiana
      • Avon, Indiana, United States, 46123
        • American Health Network of Indiana, LLC
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • Franklin, Indiana, United States, 46131
        • American Health Network of Indiana
      • Muncie, Indiana, United States, 47304
        • American Health Network of Indiana, LLC
      • Valparaiso, Indiana, United States, 46383
        • Bunyan Clinical Research
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Crescent City Clinical Research Center
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte, LLC
      • Durham, North Carolina, United States, 27713
        • University of North Carolina at Chapel Hill
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Sentral Clinical Research Services, LLC
      • Columbus, Ohio, United States, 43213
        • Columbus Clinical Research
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Lynn Institute of Norman
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • South Carolina
      • Greer, South Carolina, United States, 29651
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • BMG The Endocrine Clinic
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc.
      • Corpus Christi, Texas, United States, 78414
        • 3rd Coast Research Associates
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes and Endocrine Center
      • Dallas, Texas, United States, 75251
        • Galena Research
      • Houston, Texas, United States, 77083
        • Medstar Clinical Research and Associates
      • San Angelo, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Sound Healthcare
      • Renton, Washington, United States, 98057
        • Ranier Clinical Research Center

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ITCA 650
Drug: ITCA 650 (exenatide in DUROS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c between Week 39 and Day 0
Time Frame: 39 weeks
39 weeks

Collaborators and Investigators

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

Sponsor

Intarcia Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITCA 650-CLP-103-Sub-Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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