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Type 2 DiabetesPhase 3NCT01455857

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

A Phase 3 study testing ITCA 650 in people with Type 2 Diabetes, run by Intarcia Therapeutics at 121 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
ITCA 650
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
460 participants
Where
121 sitesUnited States
Study dates
Mar 2013to Sep 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
  • history of pancreatitis

Trial locations and contacts

121 sites in 1 country.

121 sites in 1 country

United States121 sites

  • Study Site

    Atlanta, Georgia, 30338

  • Study Site

    Austin, Texas, 78731

  • Study Site

    Austin, Texas, 78745

  • Study Site

    Avon, Indiana, 46123

  • Study Site

    Baltimore, Maryland, 21204

  • Study Site

    Bend, Oregon, 97701

  • Study Site

    Billings, Montana, 59101

  • Study Site

    Birmingham, Alabama, 35235

  • Study Site

    Boca Raton, Florida, 33432

  • Study Site

    Bradenton, Florida, 34208

  • Study Site

    Brockton, Massachusetts, 02301

  • Study Site

    Brooklyn, New York, 11218

  • Study Site

    Canton, Georgia, 30114

  • Study Site

    Carrolton, Texas, 75007

  • Study Site

    Celebration, Florida, 34747

  • Study Site

    Chandler, Arizona, 85224

  • Study Site

    Charlotte, North Carolina, 28209

  • Study Site

    Charlotte, North Carolina, 28210

  • Study Site

    Chicago, Illinois, 60607

  • Study Site

    Chicago, Illinois, 60634

  • Study Site

    Chicago, Illinois, 75251

  • Study Site

    Chula Vista, California, 91911

  • Study Site

    Cincinnati, Ohio, 45236

  • Study Site

    Cincinnati, Ohio, 45242

  • Study Site

    Clearwater, Florida, 33765

  • Study Site

    Colorado Springs, Colorado, 80907

  • Study Site

    Colorado Springs, Colorado, 80922

  • Study Site

    Columbus, Ohio, 43213

  • Study Site

    Coral Gables, Florida, 33134

  • Study Site

    Corpus Cristi, Texas, 78414

  • Study Site

    Dakota Dunes, South Dakota, 57049

  • Study Site

    Dallas, Texas, 75230

  • Study Site

    Dallas, Texas, 75251

  • Study Site

    Danville, Virginia, 24541

  • Study Site

    Daytona Beach, Florida, 32117

  • Study Site

    Des Moines, Iowa, 50314

  • Study Site

    Durham, North Carolina, 27713

  • Study Site

    Endwell, New York, 13760

  • Study Site

    Evansville, Illinois, 47714

  • Study Site

    Evansville, Indiana, 47714

  • Study Site

    Fort Worth, Texas, 76135

  • Study Site

    Franklin, Indiana, 46131

  • Study Site

    Franklin, Ohio, 45005

  • Study Site

    Fresno, California, 93721

  • Study Site

    Goodyear, Arizona, 85395

  • Study Site

    Greenfield, Indiana, 46140

  • Study Site

    Greensboro, North Carolina, 27401

  • Study Site

    Greer, South Carolina, 29651

  • Study Site

    Gulf Shores, Alabama, 36542

  • Intarcia

    Hayward, California, 94545

  • Study Site

    Hickory, North Carolina, 28602

  • Study Site

    Hollywood, Florida, 33021

  • Study Site

    Houston, Texas, 77057

  • Study Site

    Houston, Texas, 77083

  • Study Site

    Houston, Texas, 77095

  • Study Site

    Huntsville, Alabama, 35801

  • Study Site

    Idaho Falls, Idaho, 83404

  • Study Site

    Jacksonville, Florida, 32205

  • Study Site

    Jacksonville, Florida, 32216

  • Study Site

    Jacksonville, Florida, 32258

  • Study Site

    Kansas City, Missouri, 64111

  • Study Site

    Knoxville, Tennessee, 37920

  • Study Site

    Las Vegas, Nevada, 89148

  • Study Site

    Lincoln, Nebraska, 68510

  • Study Site

    Little Rock, Arkansas, 72205

  • Study Site

    Long Beach, California, 90806

  • Study Site

    Los Angeles, California, 90017

  • Study Site

    Memphis, Tennessee, 38119

  • Study Site

    Meridian, Idaho, 83646

  • Study Site

    Metaire, Louisiana, 70006

  • Study Site

    Metairie, Louisiana, 70006

  • Study Site

    Metarie, Louisiana, 70006

  • Study Site

    Miami, Florida, 33126

  • Study Site

    Miami, Florida, 33135

  • Study Site

    Miami, Florida, 33145

  • Study Site

    Miami, Florida, 33175

  • Study Site

    Miami, Florida, 33183

  • Study Site

    Moorehead City, North Carolina, 28557

  • Study Site

    Mooresville, North Carolina, 28117

  • Study Site

    Muncie, Indiana, 47304

  • Study Site

    National City, California, 91950

  • Study Site

    New Orleans, Louisiana, 70119

  • Study Site

    New Port Richey, Florida, 34652

  • Study Site

    Newton, Kansas, 67114

  • Study Site

    Norfolk, Virginia, 23510

  • Study Site

    Norman, Oklahoma, 73069

  • Study Site

    North Miami Beach, Florida, 33162

  • Study Site

    North Myrtle Beach, South Carolina, 29582

  • Study Site

    Oklahoma City, Oklahoma, 73112

  • Study Site

    Orlando, Florida, 32806

  • Study Site

    Palm Harbor, Florida, 34684

  • Study Site

    Pembroke Pines, Florida, 33026

  • Study Site

    Phoenix, Arizona, 85020

  • Study Site

    Ponte Vedra, Florida, 32081

  • Study Site

    Port Hueneme, California, 93041

  • Study Site

    Port Orchard, Washington, 98336

  • Study Site

    Renton, Washington, 98057

  • Study Site

    Richmond, Virginia, 23219

  • Study Site

    Rochester, Michigan, 48307

  • Study Site

    Salisbury, North Carolina, 28144

  • Study Site

    San Angelo, Texas, 76904

  • Study Site

    San Antonio, Texas, 78228

  • Study Site

    San Antonio, Texas, 78229

  • Study Site

    San Jose, California, 95123

  • Study Site

    San Mateo, California, 94401

  • Study Site

    Spokane, Washington, 99202

  • Study Site

    Staten Island, New York, 10301

  • Study Site

    Sugar Land, Texas, 77478

  • Study Site

    Tampa, Florida, 33603

  • Study Site

    Toledo, Ohio, 43623

  • Study Site

    Tomball, Texas, 77375

  • Study Site

    Toms River, New Jersey, 08753

  • Study Site

    Tustin, California, 92780

  • Study Site

    Uniontown, Pennsylvania, 15401

  • Study Site

    Valley Village, California, 91607

  • Study Site

    Valparaiso, Indiana, 46383

  • Study Site

    Walnut Creek, California, 94598

  • Study Site

    Watsonville, California, 95076

  • Study Site

    Wilmington, North Carolina, 28401

  • Study Site

    Winston-Salem, North Carolina, 27103

  • Study Site

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: 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.

Conditions
Type 2 Diabetes
Being tested
ITCA 650, ITCA placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ITCA 650Drug

    ITCA 650 is exenatide in DUROS

  • ITCA placeboOther

    Formulation in DUROS (no exenatide)

Study groups in NCT01455857
Study groupRoleWhat they receive
ITCA 650 40 mcg/dayExperimentalNot described
Receives: Drug: ITCA 650
ITCA 650 60 mcg/dayExperimentalNot described
Receives: Drug: ITCA 650
ITCA placeboPlacebo comparatorNot described
Receives: Other: ITCA placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    39-week Treatment Period

    Measured: 39 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2011 (estimated)
  2. Study startMar 2013
  3. Primary completionAug 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01455857
Sponsor's protocol ID
ITCA 650-CLP-103
Status last verified
Jul 2015
First submitted
18 Oct 2011
Last updated
18 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Rosenstock J, Buse JB, Azeem R, Prabhakar P, Kjems L, Huang H, Baron MA. Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial. Diabetes Care. 2018 Feb;41(2):333-340. doi: 10.2337/dc17-1306. Epub 2017 Dec 14.

    PubMed 29242349

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ITCA 650 in people with Type 2 Diabetes, run by Intarcia Therapeutics at 121 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 39 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01455857, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.

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