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

Status

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

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.
460

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

  • 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

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:

  • 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

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: 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

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
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

Sponsor

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

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 1, 2013

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.
August 1, 2014

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.
September 1, 2014

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).
October 18, 2011

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.
October 18, 2011

First Posted (Estimate)

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.
October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

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.
August 18, 2015

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.
July 28, 2015

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.
July 1, 2015

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-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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings