Type 2 DiabetesPhase 3NCT01455896
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
A Phase 3 study testing ITCA 650 in people with Type 2 Diabetes, run by Intarcia Therapeutics at 42 sites in 9 countries.
Trial summary
Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650. Read more about this study
- Who is it for?
- Ages 40 years and older
- 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
- 4,156 participants
- Where
- 42 sitesin 9 countries
- Study dates
- Mar 2013to Mar 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HBA1c > 6.5%
- History of coronary, cerebrovascular or peripheral artery disease
Who cannot join
- history of pancreatitis
Trial locations and contacts
42 sites in 9 countries.
42 sites in 9 countries
United States34 sites
Study Site
Austin, Texas, 78745
Study Site
Avon, Indiana, 46123
Study Site
Billings, Montana, 59101
Study Site
Bradenton, Florida, 34208
Study Site
Chandler, Arizona, 85224
Study Site
Chicago, Illinois, 60634
Study Site
Cincinnati, Ohio, 45236
Study Site
Columbus, Ohio, 43213
Study site
Dallas, Texas, 75230
Study Site
Dallas, Texas, 75231
Study Site
Evansville, Indiana, 47714
Study Site
Franklin, Indiana, 46131
Study Site
Franklin, Ohio, 45005
Study Site
Greenfield, Indiana, 46140
Study Site
Greer, South Carolina, 29651
Intarcia Therapeutics, Inc
Hayward, California, 94545
Study Site
Las Vegas, Nevada, 89128
Study site
Las Vegas, Nevada, 89148
Study Site
Long Beach, California, 90806
Study Site
Metaire, Louisiana, 70006
Study Site
Muncie, Indiana, 47304
Study Site
New Port Richey, Florida, 34652
Study Site
Newton, Kansas, 67114
Study Site
Palm Harbor, Florida, 34684
Study Site
Pittsburgh, Pennsylvania, 15236
Study Site
Port Hueneme, California, 93041
Study Site
Rochester, Michigan, 48307
Study Site
San Antonio, Texas, 78229
Study SIte
San Diego, California, 92114
Study Site
St Louis, Missouri, 63141
Study Site
Uniontown, Pennsylvania, 15401
Study Site
Wichita, Kansas, 67205
Study Site
Wichita, Kansas, 67207
Study Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes
Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.
- 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
ITCA placeboOther
ITCA placebo
| Study group | Role | What they receive |
|---|---|---|
| ITCA 650 60 mcg/day | Experimental | ITCA 650 is exenatide in DUROS Receives: Drug: ITCA 650 |
| ITCA placebo | Other | Not described Receives: Other: ITCA placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina),
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 4,156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intarcia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455896
- Sponsor's protocol ID
- ITCA 650-CLP-107
- Status last verified
- Jan 2017
- First submitted
- 18 Oct 2011
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruff CT, Baron M, Im K, O'Donoghue ML, Fiedorek FT, Sabatine MS. Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial. Nat Med. 2022 Jan;28(1):89-95. doi: 10.1038/s41591-021-01584-3. Epub 2021 Dec 6.
PubMed 34873344Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
PubMed 29693361
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01455896
- Acronym / sponsor ID
- ITCA 650-CLP-107
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,156 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITCA 650 60 mcg/day | Experimental | Drug: ITCA 650ITCA 650 is exenatide in DUROS |
| ITCA placebo | Other | Other: ITCA placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HBA1c > 6.5%
- History of coronary, cerebrovascular or peripheral artery disease
Key exclusion criteria (1 listed)
- history of pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITCA 650ITCA 650 | Drug | ITCA 650 60 mcg/day |
| ITCA placeboITCA placebo | Other | ITCA placebo |
Primary outcome
time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina),
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Derived from this study: PubMed 34873344Ruff CT, Baron M, Im K, O'Donoghue ML, Fiedorek FT, Sabatine MS. Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial. Nat Med. 2022 Jan;28(1):89-95. doi: 10.1038/s41591-021-01584-3. Epub 2021 Dec 6.
- Derived from this study: PubMed 29693361Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 9 countries: see every site and its status.
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 42 sites in 9 countries.
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 2 inclusion and 1 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 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Bulgaria, Denmark, Finland, Germany and 4 more countries. 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. 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?
time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina), (time frame: 2 years). 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 NCT01455896, which also lists 2 linked publications.
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 27 Jan 2017.