Diabetes Mellitus, Type 2Phase 3NCT02638805
Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
A Phase 3 study testing ITCA 650 Osmotic Mini Pump 20/60 mcg/day, ITCA 650 Osmotic Mini Pump 60 mcg/day and Metformin in people with Diabetes Mellitus, Type 2, run by Intarcia Therapeutics at 36 sites in United States.
Trial summary
A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- ITCA 650 Osmotic Mini Pump 20/60 mcg/day, ITCA 650 Osmotic Mini Pump 60 mcg/day and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 36 sitesUnited States
- Study dates
- Dec 2015to Oct 2017
- 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
- Diagnosis of type 2 diabetes ≥ 3 months.
- Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.
- HbA1c ≤9.5%.
- Stable body weight ≥ 3 months.
- Body mass index (BMI) ≥25 to ≤45 kg per meter squared.
- Calcitonin <50 ng/L (50 pg/mL) at the Screening Visit.
Who cannot join
- History of type 1 diabetes.
- Recent use or of anti-diabetic medications other than liraglutide or metformin.
- History of significant/severe nausea and/or vomiting due to liraglutide.
- Significant symptomatic hyperglycemia.
- History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
- History or evidence of acute or chronic pancreatitis.
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- History of liver disease.
- History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
- Poor thyroid, liver, or renal function.
- Serum creatinine levels >1.5mg/dL (132 μmol/L) for male patients, or >1.4 mg/dL (123 μmol/L) for female patients.
- Weight loss surgery or requires weight loss medications.
- History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years).
- History of active alcohol or substance abuse.
- Treatment with medications that affect GI motility.
- History of hypersensitivity to exenatide or liraglutide.
- Women that are pregnant, lactating, or planning to become pregnant.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
University of Colorado Hospital
Aurora, Colorado
American Health Network of Indiana, LLC
Avon, Indiana, 46123
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Meridien Research
Brooksville, Florida, 34601
Center for Advanced Medical Research
City of Saint Peters, Missouri, 63303
Erickson Research and Development
Clinton, Utah, 84015
Coastal Bend Clinical Research
Corpus Christi, Texas, 78414
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
Denver VA Medical Center
Denver, Colorado, 80220
American Health Network of Indiana, LLC
Franklin, Indiana, 46131
Prestige Clinical Research
Franklin, Ohio, 45005
American Health Network of Indiana, LLC
Greenfield, Indiana, 46140
Saint Vincent's Medical Center (BRANY)
Gulf Shores, Alabama, 36542
International Research Associates, LLC
Hialeah, Florida, 33012
Juno Research, LLC
Houston, Texas, 77036
Care Partners Clinical Research, LLC
Jacksonville, Florida, 32218
Sante Clinical Research
Kerrville, Texas, 78028
Accent Clinical Trials
Las Vegas, Nevada, 89119
Palm Research Center, Inc.
Las Vegas, Nevada, 89148
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, 72204
University of Tennessee Health Sciences Center
Memphis, Tennessee, 38103
Solaris Clinical Research
Meridian, Idaho, 83646
AMPM Research Clinic
Miami, Florida, 33145
Epocrates Medical and Research Center
Miami, Florida, 33175
Carteret Medical Group, LLC
Morehead City, North Carolina, 28557
Manhattan Medical Research
New York, New York, 10016
Lynn Institute of the Oz
Norman, Oklahoma, 73069
LION Research
Norman, Oklahoma, 73072
Sensible Healthcare, LLC
Ocoee, Florida, 34761
Panacea Clinical Research, LLC
San Antonio, Texas, 78228
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Victorium Clinical Research Ltd.
San Antonio, Texas, 78229
Radiant Research
St Louis, Missouri, 63141
Novel Research of New York
The Bronx, New York, 10461
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide
A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- ITCA 650 Osmotic Mini Pump 20/60 mcg/day, ITCA 650 Osmotic Mini Pump 60 mcg/day, Metformin, Liraglutide
- 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 Osmotic Mini Pump 20/60 mcg/dayDrug
ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
ITCA 650 Osmotic Mini Pump 60 mcg/dayDrug
ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
MetforminDrug
Stable dose for at least 3 months (at least 1000 mg/day)
LiraglutideDrug
Stable dose for at least 3 months (at least 1.2 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ITCA 650 20/60 mcg/day Receives: Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day; Drug: Metformin; Drug: Liraglutide |
| Group 2 | Experimental | ITCA 650 60 mcg/day Receives: Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day; Drug: Metformin; Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting
Number (percentage) and severity of treatment-emergent AEs (TEAEs) of nausea and/or vomiting over the 26-week treatment period; treatment discontinuation for nausea and/or vomiting; and pattern of nausea and/or vomiting over time.
Measured: From Randomization to 34 weeks
Secondary outcomes (4)
Number (percentage) and severity of all treatment-emergent adverse events
All TEAEs 2 dose regimens of ITCA 650 over 26 weeks in patients with T2D after switching from stable therapy with liraglutide
Measured: From Randomization to 34 weeks
Incidence of hypoglycemia
Measured: From Randomization to 34 weeks
Change in percentage of glycosylated hemoglobin (HbA1c) in the blood
Measured: From baseline to Week 26
Change in body weight
Change from baseline in body weight at Week 26
Measured: from baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- None (open label)
- Enrolment
- 136 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
- NCT02638805
- Sponsor's protocol ID
- ITCA 650-CLP-201
- Status last verified
- Nov 2018
- First submitted
- 18 Dec 2015
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide
- ClinicalTrials.gov ID
- NCT02638805
- Acronym / sponsor ID
- ITCA 650-CLP-201
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Dec 2015 (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.
A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day, Drug: Metformin, Drug: LiraglutideITCA 650 20/60 mcg/day |
| Group 2 | Experimental | Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day, Drug: Metformin, Drug: LiraglutideITCA 650 60 mcg/day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of type 2 diabetes ≥ 3 months.
- Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.
- HbA1c ≤9.5%.
- Stable body weight ≥ 3 months.
- Body mass index (BMI) ≥25 to ≤45 kg per meter squared.
Key exclusion criteria (16 listed)
- History of type 1 diabetes.
- Recent use or of anti-diabetic medications other than liraglutide or metformin.
- History of significant/severe nausea and/or vomiting due to liraglutide.
- Significant symptomatic hyperglycemia.
- History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
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 Osmotic Mini Pump 20/60 mcg/dayITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day | Drug | Group 1 |
| ITCA 650 Osmotic Mini Pump 60 mcg/dayITCA 650 osmotic mini pump delivering exenatide 60 mcg/day | Drug | Group 2 |
| MetforminStable dose for at least 3 months (at least 1000 mg/day) | Drug | Group 1, Group 2 |
| LiraglutideStable dose for at least 3 months (at least 1.2 mg/day) | Drug | Group 1, Group 2 |
Primary outcome
Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting
Time frame: From Randomization to 34 weeks
Number (percentage) and severity of treatment-emergent AEs (TEAEs) of nausea and/or vomiting over the 26-week treatment period; treatment discontinuation for nausea and/or vomiting; and pattern of nausea and/or vomiting over time.
4 secondary outcomes
Number (percentage) and severity of all treatment-emergent adverse events
Time frame: From Randomization to 34 weeks
Incidence of hypoglycemia
Time frame: From Randomization to 34 weeks
Change in percentage of glycosylated hemoglobin (HbA1c) in the blood
Time frame: From baseline to Week 26
Change in body weight
Time frame: from baseline to Week 26
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 5 Nov 2018.
- Individual participant dataSharing planned: No
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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.
36 sites 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 Osmotic Mini Pump 20/60 mcg/day, ITCA 650 Osmotic Mini Pump 60 mcg/day and Metformin in people with Diabetes Mellitus, Type 2, run by Intarcia Therapeutics at 36 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 6 inclusion and 16 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 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 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?
Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting (time frame: From Randomization to 34 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 5 Nov 2018.