Type 2 DiabetesPhase 3NCT01455870
A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes
A Phase 3 study testing ITCA 650 60 mcg/day and sitagliptin in people with Type 2 Diabetes, run by Intarcia Therapeutics at 54 sites in 5 countries.
Trial summary
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy 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 60 mcg/day and sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 54 sitesin 5 countries
- Study dates
- May 2013to Jul 2015
- 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% - 10.5%
- on metformin monotherapy
- BMI between 25 \& 45 kg/m2
Who cannot join
- taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
Trial locations and contacts
54 sites in 5 countries.
54 sites in 5 countries
United States50 sites
Study site
Avon, Indiana, 46123
Study site
Bend, Oregon, 97701
Study site
Billings, Montana, 59101
Study site
Birmingham, Alabama, 35235
Study site
Boca Raton, Florida, 33432
Study site
Brockton, Massachusetts, 2301
Study site
Brooklyn, New York, 11218
Study site
Canton, Georgia, 30114
Study site
Chandler, Arizona, 85224
Study site
Chicago, Illinois, 60607
Study site
Chicago, Illinois, 60634
Study site
Cincinnati, Ohio, 45227
Study site
Clearwater, Florida, 33765
Study site
Coral Gables, Florida, 33134
Study site
Corpus Christi, Texas, 78414
Study site
Dallas, Texas, 75230
Study site
Dallas, Texas, 75390
Study site
Endwell, New York, 13760
Study site
Franklin, Indiana, 46131
Study site
Greenfield, Indiana, 46140
Study site
Houston, Texas, 77083
Study site
Kettering, Ohio, 45429
Study site
Las Vegas, Nevada, 89148
Study site
Lincoln, Nebraska, 68510
Study site
Long Beach, California, 90807
Study site
Los Angeles, California, 90017
Study site
Memphis, Tennessee, 38119
Study site
Metairie, Louisiana, 70006
Study site
Miami, Florida, 33126
Study site
Morehead City, North Carolina, 28557
Study site
Muncie, Indiana, 47304
Study site
Norman, Oklahoma, 73069
Study site
North Miami Beach, Florida, 33162
Study site
Pembroke Pines, Florida, 33026
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92101
Study site
San Mateo, California, 94401
Study site
St Louis, Missouri, 63110
Study site
Sugar Land, Texas, 77478
Study site
Tomball, Texas, 77375
Study site
Traverse City, Michigan, 49684
Study site
Troy, Michigan, 48098
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
Wichita, Kansas, 67205
Study site
Wichita, Kansas, 67208
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- ITCA 650 60 mcg/day, sitagliptin
- 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 650 60 mcg/dayDrug
exenatide in DUROS
sitagliptinDrug
oral sitagliptin 100 mg/day
| Study group | Role | What they receive |
|---|---|---|
| ITCA 650 60 mcg/day | Experimental | ITCA 650 is exenatide in DUROS Receives: Drug: ITCA 650 60 mcg/day |
| sitagliptin | Active comparator | sitagliptin 100 mg/day Receives: Drug: sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c between Week 52 and Day 0
Measured: 52 weeks
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 startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 535 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
- NCT01455870
- Sponsor's protocol ID
- ITCA 650-CLP-105
- Status last verified
- May 2016
- First submitted
- 18 Oct 2011
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01455870
- Acronym / sponsor ID
- ITCA 650-CLP-105
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (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 compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.
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 650 60 mcg/dayITCA 650 is exenatide in DUROS |
| sitagliptin | Active comparator | Drug: sitagliptinsitagliptin 100 mg/day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HbA1c between 7.5% - 10.5%
- on metformin monotherapy
- BMI between 25 \& 45 kg/m2
Key exclusion criteria (2 listed)
- taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- 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 650 60 mcg/dayexenatide in DUROS | Drug | ITCA 650 60 mcg/day |
| sitagliptinoral sitagliptin 100 mg/day | Drug | sitagliptin |
Primary outcome
Change in HbA1c between Week 52 and Day 0
Time frame: 52 weeks
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 2 Jun 2016.
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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.
54 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ITCA 650 60 mcg/day and sitagliptin in people with Type 2 Diabetes, run by Intarcia Therapeutics at 54 sites in 5 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 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 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Croatia, Denmark, Germany, Latvia. 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?
Change in HbA1c between Week 52 and Day 0 (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2016.