Type 2 DiabetesPhase 1NCT01798264
Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
A Phase 1 study testing ITCA 650 (exenatide in DUROS) in people with Type 2 Diabetes, run by Intarcia Therapeutics at 3 sites in United States.
Trial summary
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- ITCA 650 (exenatide in DUROS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2009to May 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes >6 months
- stable diet \& exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%
Who cannot join
- prior treatment with exenatide
- history of pancreatitis
- history of medullary thyroid cancer or multiple endocrine neoplasia 2
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45212
Study site
Miami Gardens, Florida, 33169
dGd Research
San Antonio, Texas, 78229
About this study
Official title: A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes
- Being tested
- ITCA 650 (exenatide in DUROS)
- 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 (exenatide in DUROS)Drug
| Study group | Role | What they receive |
|---|---|---|
| 10 mcg./day | Experimental | ITCA 650 (exenatide in DUROS) Receives: Drug: ITCA 650 (exenatide in DUROS) |
| 20 mcg/day | Experimental | ITCA 650 (exenatide in DUROS) Receives: Drug: ITCA 650 (exenatide in DUROS) |
| 40 mcg/day | Experimental | ITCA 650 (exenatide in DUROS) Receives: Drug: ITCA 650 (exenatide in DUROS) |
| 80 mcg/day | Experimental | ITCA 650 (exenatide in DUROS) Receives: Drug: ITCA 650 (exenatide in DUROS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Study Drug-Related Adverse Events
Measured: 4 weeks
Secondary outcomes (3)
To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Change in HbA1c from baseline
Measured: 4 weeks
Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline
Measured: 4 weeks
Change in Weight From Baseline to 4 Weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT01798264
- Sponsor's protocol ID
- ITCA 650-CLP-01
- Status last verified
- Apr 2013
- First submitted
- 20 Feb 2013
- Last updated
- 17 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Henry RR, Logan D, Alessi T, Baron MA. A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes. Clin Ther. 2013 May;35(5):634-645.e1. doi: 10.1016/j.clinthera.2013.03.011. Epub 2013 Apr 8.
PubMed 23578605
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01798264
- Acronym / sponsor ID
- ITCA 650-CLP-01
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Posted 17 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 mcg./day | Experimental | Drug: ITCA 650 (exenatide in DUROS)ITCA 650 (exenatide in DUROS) |
| 20 mcg/day | Experimental | Drug: ITCA 650 (exenatide in DUROS)ITCA 650 (exenatide in DUROS) |
| 40 mcg/day | Experimental | Drug: ITCA 650 (exenatide in DUROS)ITCA 650 (exenatide in DUROS) |
| 80 mcg/day | Experimental | Drug: ITCA 650 (exenatide in DUROS)ITCA 650 (exenatide in DUROS) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes >6 months
- stable diet \& exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%
Key exclusion criteria (3 listed)
- prior treatment with exenatide
- history of pancreatitis
- history of medullary thyroid cancer or multiple endocrine neoplasia 2
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 (exenatide in DUROS) | Drug | 10 mcg./day, 20 mcg/day, 40 mcg/day, 80 mcg/day |
Primary outcome
Number of Subjects With Study Drug-Related Adverse Events
Time frame: 4 weeks
3 secondary outcomes
To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Time frame: 4 weeks
Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline
Time frame: 4 weeks
Change in Weight From Baseline to 4 Weeks
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23578605Henry RR, Logan D, Alessi T, Baron MA. A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes. Clin Ther. 2013 May;35(5):634-645.e1. doi: 10.1016/j.clinthera.2013.03.011. Epub 2013 Apr 8.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITCA 650 (exenatide in DUROS) in people with Type 2 Diabetes, run by Intarcia Therapeutics at 3 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 2 inclusion and 3 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 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Study Drug-Related Adverse Events (time frame: 4 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 NCT01798264, 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 17 May 2013.