A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes

July 28, 2015 updated by: Intarcia Therapeutics

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes

Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

460

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
        • Study Site
      • Gulf Shores, Alabama, United States, 36542
        • Study Site
      • Huntsville, Alabama, United States, 35801
        • Study Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Study Site
      • Goodyear, Arizona, United States, 85395
        • Study Site
      • Phoenix, Arizona, United States, 85020
        • Study Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Study Site
    • California
      • Chula Vista, California, United States, 91911
        • Study Site
      • Fresno, California, United States, 93721
        • Study Site
      • Hayward, California, United States, 94545
        • Intarcia
      • Long Beach, California, United States, 90806
        • Study Site
      • Los Angeles, California, United States, 90017
        • Study Site
      • National City, California, United States, 91950
        • Study Site
      • Port Hueneme, California, United States, 93041
        • Study Site
      • San Jose, California, United States, 95123
        • Study Site
      • San Mateo, California, United States, 94401
        • Study Site
      • Tustin, California, United States, 92780
        • Study Site
      • Valley Village, California, United States, 91607
        • Study Site
      • Walnut Creek, California, United States, 94598
        • Study Site
      • Watsonville, California, United States, 95076
        • Study Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Study Site
      • Colorado Springs, Colorado, United States, 80922
        • Study Site
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Study Site
      • Bradenton, Florida, United States, 34208
        • Study Site
      • Celebration, Florida, United States, 34747
        • Study Site
      • Clearwater, Florida, United States, 33765
        • Study Site
      • Coral Gables, Florida, United States, 33134
        • Study Site
      • Daytona Beach, Florida, United States, 32117
        • Study Site
      • Hollywood, Florida, United States, 33021
        • Study Site
      • Jacksonville, Florida, United States, 32205
        • Study Site
      • Jacksonville, Florida, United States, 32216
        • Study Site
      • Jacksonville, Florida, United States, 32258
        • Study Site
      • Miami, Florida, United States, 33183
        • Study Site
      • Miami, Florida, United States, 33126
        • Study Site
      • Miami, Florida, United States, 33135
        • Study Site
      • Miami, Florida, United States, 33145
        • Study Site
      • Miami, Florida, United States, 33175
        • Study Site
      • N. Miami Beach, Florida, United States, 33162
        • Study Site
      • New Port Richey, Florida, United States, 34652
        • Study Site
      • North Miami Beach, Florida, United States, 33162
        • Study Site
      • Orlando, Florida, United States, 32806
        • Study Site
      • Palm Harbor, Florida, United States, 34684
        • Study Site
      • Pembroke Pines, Florida, United States, 33026
        • Study Site
      • Ponte Vedra, Florida, United States, 32081
        • Study Site
      • Tampa, Florida, United States, 33603
        • Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Study Site
      • Canton, Georgia, United States, 30114
        • Study Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Study Site
      • Meridian, Idaho, United States, 83646
        • Study Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Study Site
      • Chicago, Illinois, United States, 60634
        • Study Site
      • Chicago, Illinois, United States, 75251
        • Study Site
      • Evansville, Illinois, United States, 47714
        • Study Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Study Site
      • Evansville, Indiana, United States, 47714
        • Study Site
      • Franklin, Indiana, United States, 46131
        • Study Site
      • Greenfield, Indiana, United States, 46140
        • Study Site
      • Muncie, Indiana, United States, 47304
        • Study Site
      • Valparaiso, Indiana, United States, 46383
        • Study Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Study Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Study Site
    • Louisiana
      • Metaire, Louisiana, United States, 70006
        • Study Site
      • Metairie, Louisiana, United States, 70006
        • Study Site
      • Metarie, Louisiana, United States, 70006
        • Study Site
      • New Orleans, Louisiana, United States, 70119
        • Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Study Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Study Site
    • Michigan
      • Rochester, Michigan, United States, 48307
        • Study Site
      • Ypsilanti, Michigan, United States, 48197
        • Study Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Study Site
    • Montana
      • Billings, Montana, United States, 59101
        • Study Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Study Site
    • New Jersey
      • Toms RIver, New Jersey, United States, 08753
        • Study Site
    • New York
      • Brooklyn, New York, United States, 11218
        • Study Site
      • Endwell, New York, United States, 13760
        • Study Site
      • Staten Island, New York, United States, 10301
        • Study Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Study Site
      • Charlotte, North Carolina, United States, 28210
        • Study Site
      • Durham, North Carolina, United States, 27713
        • Study Site
      • Greensboro, North Carolina, United States, 27401
        • Study Site
      • Hickory, North Carolina, United States, 28602
        • Study Site
      • Moorehead City, North Carolina, United States, 28557
        • Study Site
      • Mooresville, North Carolina, United States, 28117
        • Study Site
      • Salisbury, North Carolina, United States, 28144
        • Study Site
      • Wilmington, North Carolina, United States, 28401
        • Study Site
      • Winston-Salem, North Carolina, United States, 27103
        • Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Study Site
      • Cincinnati, Ohio, United States, 45242
        • Study Site
      • Columbus, Ohio, United States, 43213
        • Study Site
      • Franklin, Ohio, United States, 45005
        • Study Site
      • Toledo, Ohio, United States, 43623
        • Study Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Study Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Study Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Study Site
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • Study Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Study Site
      • N. Myrtle Beach, South Carolina, United States, 29582
        • Study Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Study Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Study Site
      • Memphis, Tennessee, United States, 38119
        • Study Site
    • Texas
      • Austin, Texas, United States, 78731
        • Study Site
      • Austin, Texas, United States, 78745
        • Study Site
      • Carrolton, Texas, United States, 75007
        • Study Site
      • Corpus Cristi, Texas, United States, 78414
        • Study Site
      • Dallas, Texas, United States, 75230
        • Study Site
      • Dallas, Texas, United States, 75251
        • Study Site
      • Fort Worth, Texas, United States, 76135
        • Study Site
      • Houston, Texas, United States, 77057
        • Study Site
      • Houston, Texas, United States, 77083
        • Study Site
      • Houston, Texas, United States, 77095
        • Study Site
      • San Angelo, Texas, United States, 76904
        • Study Site
      • San Antonio, Texas, United States, 78229
        • Study Site
      • San Antonio, Texas, United States, 78228
        • Study Site
      • Sugar Land, Texas, United States, 77478
        • Study Site
      • Tomball, Texas, United States, 77375
        • Study Site
    • Virginia
      • Danville, Virginia, United States, 24541
        • Study Site
      • Norfolk, Virginia, United States, 23510
        • Study Site
      • Richmond, Virginia, United States, 23219
        • Study Site
    • Washington
      • Port Orchard, Washington, United States, 98336
        • Study Site
      • Renton, Washington, United States, 98057
        • Study Site
      • Spokane, Washington, United States, 99202
        • Study Site

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:

  • HbA1c between 7.5% - 10%
  • On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
  • BMI between 25 & 45 kg/m2

Exclusion Criteria:

  • taking DPP-4 inhibitors, exenatide, liraglutide, 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ITCA 650 60 mcg/day
Drug: ITCA 650
ITCA 650 is exenatide in DUROS
Experimental: ITCA 650 40 mcg/day
Drug: ITCA 650
ITCA 650 is exenatide in DUROS
Placebo Comparator: ITCA placebo
Other: ITCA placebo
Formulation in DUROS (no exenatide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 39 weeks
39-week Treatment Period
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

March 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITCA 650-CLP-103

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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