Type 2 DiabetesPhase 3NCT01455883
A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes
A Phase 3 study testing ITCA 650 60 mcg/day and glimepiride in people with Type 2 Diabetes, run by Intarcia Therapeutics at 1 site in United States.
Trial summary
Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy 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 60 mcg/day and glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 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% - 10.5%
- on metformin monotherapy
- BMI between 25 \& 45 kg/m2
Who cannot join
- on thiazolidinedione, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Intarcia Therapeutics, Inc
Hayward, California, 94545
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 Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- ITCA 650 60 mcg/day, glimepiride
- 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
glimepirideDrug
oral glimepiride does-escalated,if tolerated, to 8 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 |
| glimepiride | Active comparator | glimepiride up-titrated to 8 mg/day over first 13 weeks Receives: Drug: glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
52-Week Treatment Period
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 startFeb 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
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
- 0 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
- NCT01455883
- Sponsor's protocol ID
- ITCA 650-CLP-106
- Status last verified
- Dec 2012
- First submitted
- 18 Oct 2011
- Last updated
- 25 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2012. 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 Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01455883
- Acronym / sponsor ID
- ITCA 650-CLP-106
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- 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 examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c 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 |
| glimepiride | Active comparator | Drug: glimepirideglimepiride up-titrated to 8 mg/day over first 13 weeks |
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)
- on thiazolidinedione, sulfonylureas, 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 |
| glimepirideoral glimepiride does-escalated,if tolerated, to 8 mg/day | Drug | glimepiride |
Primary outcome
Change in HbA1c
Time frame: 52 weeks
52-Week Treatment Period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2012.
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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.
1 site in 1 country: 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 glimepiride in people with Type 2 Diabetes, run by Intarcia Therapeutics at 1 site 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: withdrawn, as of the sponsor's last update on 25 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 was withdrawn before enrolling participants, so there are no results.
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: 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 25 Dec 2012.