Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin
Sponsor
Intarcia Therapeutics (Industry)
Overall Status
Terminated
CT.gov ID
NCT03060980
Collaborator
(none)
245
101
3
10.8
2.4
0.2
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
245 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Mar 3, 2017
Actual Primary Completion Date
:
Jan 26, 2018
Actual Study Completion Date
:
Jan 26, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: Group 1 ITCA 650 20/60 mcg/day |
Drug: ITCA 650 20/60 mcg/day
ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
|
| Experimental: Experimental: Group 2 Empagliflozin 10 mg/day and 25 mg/day |
Drug: Empagliflozin (oral)
10 mg/day and 25 mg/day
|
| Experimental: Experimental: Group 3 Glimepiride 1-6 mg/day |
Drug: Glimepiride (oral)
1-6 mg/day
|
Outcome Measures
Primary Outcome Measures
- Reduction in glycosylated hemoglobin A1c [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 [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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).
Exclusion Criteria:
-
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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fountain Hills Family Practice, P.C. | Fountain Hills | Arizona | United States | 85268 |
| 2 | Thomas C. Lenzmeier, M.D., P.C. | Glendale | Arizona | United States | 85308 |
| 3 | Family Practice Specialists | Phoenix | Arizona | United States | 85018 |
| 4 | Central Phoenix Medical Center | Phoenix | Arizona | United States | 85020 |
| 5 | Fiel Family and Sports Medicine | Tempe | Arizona | United States | 85283 |
| 6 | Arizona Community Physicians | Tucson | Arizona | United States | 85712 |
| 7 | Orange Grove Family Practice | Tucson | Arizona | United States | 85741 |
| 8 | Anaheim Clinical Trials | Anaheim | California | United States | 92801 |
| 9 | Radiant Research | Carlsbad | California | United States | 92008 |
| 10 | Research Center of Fresno, Inc. | Fresno | California | United States | 93726 |
| 11 | Marin Endocrine Care and Research, Inc. | Greenbrae | California | United States | 94904 |
| 12 | National Research Institute | Huntington Park | California | United States | 90255 |
| 13 | National Research Institute | Los Angeles | California | United States | 91402 |
| 14 | Catalina Research Institute | Montclair | California | United States | 91710 |
| 15 | Providence Clinical Research | North Hollywood | California | United States | 91606 |
| 16 | Center for Clinical Trials of Sacramento, Inc. | Sacramento | California | United States | 95816 |
| 17 | Denver VA Medical Center | Aurora | Colorado | United States | 80045 |
| 18 | Radiant Research | Centennial | Colorado | United States | 75115 |
| 19 | Colorado Springs Health Partners - East | Colorado Springs | Colorado | United States | 80922 |
| 20 | Columbine Family Practice | Littleton | Colorado | United States | 80128 |
| 21 | Nature Coast Clinical Reseaerch - Crystal River | Crystal River | Florida | United States | 34429 |
| 22 | Indago Research and Health Center, Inc. | Hialeah | Florida | United States | 33012 |
| 23 | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | United States | 32256 |
| 24 | Research Institure of South Florida | Miami | Florida | United States | 33173 |
| 25 | Clinical Neuroscience Solutions, Inc. | Orlando | Florida | United States | 32801 |
| 26 | Palm Harbor Medical Associates | Palm Harbor | Florida | United States | 34684 |
| 27 | Andres Patron, D.O., P.A | Pembroke Pines | Florida | United States | 33026 |
| 28 | South Broward Research | Pembroke Pines | Florida | United States | 33027 |
| 29 | Primary Care Research Group | Atlanta | Georgia | United States | 30312 |
| 30 | Atlanta Center for Medical Research | Atlanta | Georgia | United States | 30331 |
| 31 | Solaris Clinical Research | Meridian | Idaho | United States | 83646 |
| 32 | Michigan Avenue Internists | Chicago | Illinois | United States | 60604 |
| 33 | Medical and Procedural Specialists | Skokie | Illinois | United States | 60077 |
| 34 | HSHS Medical Group DIabetes Research | Springfield | Illinois | United States | 62711 |
| 35 | Community Hospital of Anderson and Madison County, Inc. | Anderson | Indiana | United States | 46011 |
| 36 | Clinical Research Advantage | Evansville | Indiana | United States | 47225 |
| 37 | American Health Network of Indiana, LLC | Franklin | Indiana | United States | 46131 |
| 38 | American Health Network of Indiana, LLC | New Albany | Indiana | United States | 47150 |
| 39 | Heartland Research Associates, LLC | Augusta | Kansas | United States | 67010 |
| 40 | Overland Park Surgical Specialists, LLL dba College Park Family Care Center | Overland Park | Kansas | United States | 66210 |
| 41 | Cotton O'Neil Clinical Research Center | Topeka | Kansas | United States | 66606 |
| 42 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67205 |
| 43 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67207 |
| 44 | Pennington Biomedical Research Center | Baton Rouge | Louisiana | United States | 70808 |
| 45 | Maine Research Associates | Auburn | Maine | United States | 04210 |
| 46 | Joslin Diabetes Center | Boston | Massachusetts | United States | 02215 |
| 47 | Radiant Research, Inc. | Edina | Minnesota | United States | 55435 |
| 48 | Ehrhardt Clinical Research, LLC | Belton | Missouri | United States | 64012 |
| 49 | HealthCare Research Network | Hazelwood | Missouri | United States | 63042 |
| 50 | Mercury Street Medical Group | Butte | Montana | United States | 59701 |
| 51 | Skyline Medical Center | Elkhorn | Nebraska | United States | 68022 |
| 52 | Nevada Family Care | Henderson | Nevada | United States | 89047 |
| 53 | Palm Research Center, Inc. | Las Vegas | Nevada | United States | 89148 |
| 54 | Albany Medical College | Albany | New York | United States | 12208 |
| 55 | Scott Research Center | Laurelton | New York | United States | 11413 |
| 56 | American Health Research | Charlotte | North Carolina | United States | 28207 |
| 57 | Medication Management, LLC | Greensboro | North Carolina | United States | 27408 |
| 58 | Down East Medical Associates, PA | Morehead City | North Carolina | United States | 28557 |
| 59 | PMG Research of Wilmington, LLC | Wilmington | North Carolina | United States | 28401 |
| 60 | Radiant Research | Akron | Ohio | United States | 44311 |
| 61 | Sentral Clinical Research Services, LLC | Cincinnati | Ohio | United States | 45236 |
| 62 | Canyon Medical Center, LLC | Columbus | Ohio | United States | 43213 |
| 63 | Aventiv Research | Columbus | Ohio | United States | 43231 |
| 64 | Prestige Clinical Research | Franklin | Ohio | United States | 45005 |
| 65 | Wells Institute for Health Awareness | Kettering | Ohio | United States | 45429 |
| 66 | University of Toledo | Toledo | Ohio | United States | 43614 |
| 67 | Oklahoma City Clinic - Midwest City | Midwest City | Oklahoma | United States | 73110 |
| 68 | Intend Research | Norman | Oklahoma | United States | 73069 |
| 69 | Oklahoma City Clinic - Central | Oklahoma City | Oklahoma | United States | 73104 |
| 70 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
| 71 | Clinical Research Institute of Southern Oregon, PC | Medford | Oregon | United States | 97504 |
| 72 | Harleysville Medical Associates | Harleysville | Pennsylvania | United States | 19438 |
| 73 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 74 | Preferred Primary Care Phys Inc | Pittsburgh | Pennsylvania | United States | 15243 |
| 75 | Preferred Primary Care Physicians | Uniontown | Pennsylvania | United States | 15401 |
| 76 | Clinical Research of Rock Hill | Rock Hill | South Carolina | United States | 29732 |
| 77 | Spartanburg Medical Research | Spartanburg | South Carolina | United States | 29303 |
| 78 | Holston Medical Group, P.C. | Kingsport | Tennessee | United States | 37660 |
| 79 | Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | United States | 38119 |
| 80 | DCT-AACT, LLC dba Discovery Clinical Trials | Austin | Texas | United States | 78758 |
| 81 | Dallas Diabetes and Endocrine Center | Dallas | Texas | United States | 75230 |
| 82 | Research Institute of Dallas | Dallas | Texas | United States | 75231 |
| 83 | Global Medical Research | DeSoto | Texas | United States | 75115 |
| 84 | Juno Research | Houston | Texas | United States | 77004 |
| 85 | PCP for Life - -Tidwell | Houston | Texas | United States | 77093 |
| 86 | Sante Clinical Research | Kerrville | Texas | United States | 78028 |
| 87 | Health Texas Research Institute | San Angelo | Texas | United States | 78228 |
| 88 | Panacea Clinical Research | San Antonio | Texas | United States | 78228 |
| 89 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
| 90 | Victorium Clinical Research Ltd. | San Antonio | Texas | United States | 78230 |
| 91 | MacGregor Medical Center | San Antonio | Texas | United States | 78240 |
| 92 | Crossroads Clinical Research, LLC | Victoria | Texas | United States | 77901 |
| 93 | Ericksen Research and Development, LLC | Clinton | Utah | United States | 84015 |
| 94 | Radiant Research | Murray | Utah | United States | 84123 |
| 95 | Advanced Clinical Research | West Jordan | Utah | United States | 84088 |
| 96 | Sound Healthcare | Port Orchard | Washington | United States | 98366 |
| 97 | Bailey Clinic | Red Deer | Alberta | Canada | T466V7 |
| 98 | CookMed Research | Victoria | British Columbia | Canada | V8V 4A1 |
| 99 | Milestone Research | London | Ontario | Canada | N5W 6A2 |
| 100 | Bluewater Clinical Research Group | Sarnia | Ontario | Canada | N7T 4X3 |
| 101 | Dr. Anil K. Gupta Medicine Professional Corporation | Toronto | Ontario | Canada | M9V 4B4 |
Sponsors and Collaborators
- Intarcia Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT03060980
Other Study ID Numbers:
- ITCA 650-CLP-203
First Posted:
Feb 23, 2017
Last Update Posted:
Mar 7, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: