Diabetes Mellitus, Type 2Phase 3NCT03060980
Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin
A Phase 3 study testing ITCA 650 20/60 mcg/day, Empagliflozin (oral) and Glimepiride (oral) in people with Diabetes Mellitus, Type 2, run by Intarcia Therapeutics at 101 sites in 2 countries.
Trial summary
A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin 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
- Diabetes Mellitus, Type 2
- What is being tested?
- ITCA 650 20/60 mcg/day, Empagliflozin (oral) and Glimepiride (oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 101 sitesin 2 countries
- Study dates
- 3 Mar 2017to 26 Jan 2018
- 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 T2D 3 months prior to the Screening Visit.
- Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.
- Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).
Who cannot join
- History of type 1 diabetes.
- Prior participation in a clinical study involving ITCA 650.
- Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening.
- 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.
- History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
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- Treatment of medications that affect GI motility.
- History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients.
- Women that are pregnant, lactating, or planning to become pregnant.
- Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.
Trial locations and contacts
101 sites in 2 countries.
101 sites in 2 countries
United States96 sites
Radiant Research
Akron, Ohio, 44311
Albany Medical College
Albany, New York, 12208
Anaheim Clinical Trials
Anaheim, California, 92801
Community Hospital of Anderson and Madison County, Inc.
Anderson, Indiana, 46011
Primary Care Research Group
Atlanta, Georgia, 30312
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Maine Research Associates
Auburn, Maine, 04210
Heartland Research Associates, LLC
Augusta, Kansas, 67010
Denver VA Medical Center
Aurora, Colorado, 80045
DCT-AACT, LLC dba Discovery Clinical Trials
Austin, Texas, 78758
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Ehrhardt Clinical Research, LLC
Belton, Missouri, 64012
Joslin Diabetes Center
Boston, Massachusetts, 02215
Mercury Street Medical Group
Butte, Montana, 59701
Radiant Research
Carlsbad, California, 92008
Radiant Research
Centennial, Colorado, 75115
American Health Research
Charlotte, North Carolina, 28207
Michigan Avenue Internists
Chicago, Illinois, 60604
Sentral Clinical Research Services, LLC
Cincinnati, Ohio, 45236
Ericksen Research and Development, LLC
Clinton, Utah, 84015
Colorado Springs Health Partners - East
Colorado Springs, Colorado, 80922
Canyon Medical Center, LLC
Columbus, Ohio, 43213
Aventiv Research
Columbus, Ohio, 43231
Nature Coast Clinical Reseaerch - Crystal River
Crystal River, Florida, 34429
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
Research Institute of Dallas
Dallas, Texas, 75231
Global Medical Research
DeSoto, Texas, 75115
Radiant Research, Inc.
Edina, Minnesota, 55435
Skyline Medical Center
Elkhorn, Nebraska, 68022
Clinical Research Advantage
Evansville, Indiana, 47225
Fountain Hills Family Practice, P.C.
Fountain Hills, Arizona, 85268
American Health Network of Indiana, LLC
Franklin, Indiana, 46131
Prestige Clinical Research
Franklin, Ohio, 45005
Research Center of Fresno, Inc.
Fresno, California, 93726
Thomas C. Lenzmeier, M.D., P.C.
Glendale, Arizona, 85308
Marin Endocrine Care and Research, Inc.
Greenbrae, California, 94904
Medication Management, LLC
Greensboro, North Carolina, 27408
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438
HealthCare Research Network
Hazelwood, Missouri, 63042
Nevada Family Care
Henderson, Nevada, 89047
Indago Research and Health Center, Inc.
Hialeah, Florida, 33012
Juno Research
Houston, Texas, 77004
PCP for Life - -Tidwell
Houston, Texas, 77093
National Research Institute
Huntington Park, California, 90255
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Sante Clinical Research
Kerrville, Texas, 78028
Wells Institute for Health Awareness
Kettering, Ohio, 45429
Holston Medical Group, P.C.
Kingsport, Tennessee, 37660
Palm Research Center, Inc.
Las Vegas, Nevada, 89148
Scott Research Center
Laurelton, New York, 11413
Columbine Family Practice
Littleton, Colorado, 80128
National Research Institute
Los Angeles, California, 91402
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Solaris Clinical Research
Meridian, Idaho, 83646
Research Institure of South Florida
Miami, Florida, 33173
Oklahoma City Clinic - Midwest City
Midwest City, Oklahoma, 73110
Catalina Research Institute
Montclair, California, 91710
Down East Medical Associates, PA
Morehead City, North Carolina, 28557
Radiant Research
Murray, Utah, 84123
American Health Network of Indiana, LLC
New Albany, Indiana, 47150
Intend Research
Norman, Oklahoma, 73069
Providence Clinical Research
North Hollywood, California, 91606
Oklahoma City Clinic - Central
Oklahoma City, Oklahoma, 73104
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Overland Park Surgical Specialists, LLL dba College Park Family Care Center
Overland Park, Kansas, 66210
Palm Harbor Medical Associates
Palm Harbor, Florida, 34684
Andres Patron, D.O., P.A
Pembroke Pines, Florida, 33026
South Broward Research
Pembroke Pines, Florida, 33027
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Family Practice Specialists
Phoenix, Arizona, 85018
Central Phoenix Medical Center
Phoenix, Arizona, 85020
Preferred Primary Care Phys Inc
Pittsburgh, Pennsylvania, 15243
Sound Healthcare
Port Orchard, Washington, 98366
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Center for Clinical Trials of Sacramento, Inc.
Sacramento, California, 95816
Health Texas Research Institute
San Angelo, Texas, 78228
Panacea Clinical Research
San Antonio, Texas, 78228
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Victorium Clinical Research Ltd.
San Antonio, Texas, 78230
MacGregor Medical Center
San Antonio, Texas, 78240
Medical and Procedural Specialists
Skokie, Illinois, 60077
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
HSHS Medical Group DIabetes Research
Springfield, Illinois, 62711
Fiel Family and Sports Medicine
Tempe, Arizona, 85283
University of Toledo
Toledo, Ohio, 43614
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Arizona Community Physicians
Tucson, Arizona, 85712
Orange Grove Family Practice
Tucson, Arizona, 85741
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
Crossroads Clinical Research, LLC
Victoria, Texas, 77901
Advanced Clinical Research
West Jordan, Utah, 84088
Heartland Research Associates, LLC
Wichita, Kansas, 67205
Heartland Research Associates, LLC
Wichita, Kansas, 67207
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Canada5 sites
Milestone Research
London, Ontario, N5W 6A2
Bailey Clinic
Red Deer, Alberta, T466V7
Bluewater Clinical Research Group
Sarnia, Ontario, N7T 4X3
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4
CookMed Research
Victoria, British Columbia, V8V 4A1
About this study
Official title: A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- ITCA 650 20/60 mcg/day, Empagliflozin (oral), Glimepiride (oral)
- 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 20/60 mcg/dayDrug
ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
Empagliflozin (oral)Drug
10 mg/day and 25 mg/day
Glimepiride (oral)Drug
1-6 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group 1 | Experimental | ITCA 650 20/60 mcg/day Receives: Drug: ITCA 650 20/60 mcg/day |
| Experimental: Group 2 | Experimental | Empagliflozin 10 mg/day and 25 mg/day Receives: Drug: Empagliflozin (oral) |
| Experimental: Group 3 | Experimental | Glimepiride 1-6 mg/day Receives: Drug: Glimepiride (oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in glycosylated hemoglobin A1c
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Measured: Randomization to 69 weeks
Reduction in weight
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Measured: Randomization to 69 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start3 Mar 2017
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
Why it stopped: Decision by Sponsor
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
- 245 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
- NCT03060980
- Sponsor's protocol ID
- ITCA 650-CLP-203
- Status last verified
- Mar 2019
- First submitted
- 9 Feb 2017
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03060980
- Acronym / sponsor ID
- ITCA 650-CLP-203
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision by Sponsor
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group 1 | Experimental | Drug: ITCA 650 20/60 mcg/dayITCA 650 20/60 mcg/day |
| Experimental: Group 2 | Experimental | Drug: Empagliflozin (oral)Empagliflozin 10 mg/day and 25 mg/day |
| Experimental: Group 3 | Experimental | Drug: Glimepiride (oral)Glimepiride 1-6 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)
- Diagnosis of T2D 3 months prior to the Screening Visit.
- Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.
- Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).
Key exclusion criteria (10 listed)
- History of type 1 diabetes.
- Prior participation in a clinical study involving ITCA 650.
- Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening.
- 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.
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 20/60 mcg/dayITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day | Drug | Experimental: Group 1 |
| Empagliflozin (oral)10 mg/day and 25 mg/day | Drug | Experimental: Group 2 |
| Glimepiride (oral)1-6 mg/day | Drug | Experimental: Group 3 |
Primary outcome
Reduction in glycosylated hemoglobin A1c
Time frame: Randomization to 69 weeks
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Reduction in weight
Time frame: Randomization to 69 weeks
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Results and safety
The study was stopped early (reason given: Decision by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- 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.
101 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ITCA 650 20/60 mcg/day, Empagliflozin (oral) and Glimepiride (oral) in people with Diabetes Mellitus, Type 2, run by Intarcia Therapeutics at 101 sites in 2 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 10 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: stopped early, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in United States, Canada. 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 stopped early (reason given: Decision by Sponsor). Results are not available in the source record.
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?
Reduction in glycosylated hemoglobin A1c (time frame: Randomization to 69 weeks). The study lists 2 primary outcomes in all. 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 7 Mar 2019.