A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
Sponsor
Intarcia Therapeutics (Industry)
Overall Status
Terminated
CT.gov ID
NCT01785771
Collaborator
(none)
100
51
1
56
2
0
Study Details
Study Description
Brief Summary
An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c
Study Start Date
:
May 1, 2013
Actual Primary Completion Date
:
Jan 1, 2018
Actual Study Completion Date
:
Jan 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ITCA 650
|
Drug: ITCA 650 (exenatide in DUROS)
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c between Week 39 and Day 0 [39 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Men or women age 18 to 80 years with type 2 diabetes
-
On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
-
HbA1c >10.0% and ≤12.0%
Exclusion Criteria:
-
Prior treatment with any GLP-1 receptor agonist
-
History of hypersensitivity to exenatide or liraglutide
-
FPG >300 mg/dL
-
History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
-
Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
-
history of pancreatitis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | United States | 35235 |
| 2 | Fundamental Research | Gulf Shores | Alabama | United States | 36542 |
| 3 | East Valley Family Physicians, PLC | Chandler | Arizona | United States | 85224 |
| 4 | Desert Clinical Research | Mesa | Arizona | United States | 85213 |
| 5 | Clinical Research Advantage, Inc. | Phoenix | Arizona | United States | 85020 |
| 6 | eStudySite | Chula Vista | California | United States | |
| 7 | Rocks Medical Research Institute, Inc. | Fresno | California | United States | 93721 |
| 8 | Rocks Medical Research Institute | Fresno | California | United States | 93721 |
| 9 | Long Beach Center for Clinical Research | Long Beach | California | United States | 90807 |
| 10 | Saviers Medical Group | Port Hueneme | California | United States | 93041 |
| 11 | University Clinical Investigatons, Inc/Diabetes Research Center | Tustin | California | United States | 92780 |
| 12 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
| 13 | Colorado Springs Health Partners-Briargate | Colorado Springs | Colorado | United States | 80922 |
| 14 | Meridien Research | Bradenton | Florida | United States | 34208 |
| 15 | East Coast Institute for Research, LLC | Jacksonville | Florida | United States | 32216 |
| 16 | New Horizon Research Center, Inc. | Miami | Florida | United States | 33175 |
| 17 | International Research Assocaites, LLC | Miami | Florida | United States | 33183 |
| 18 | Harmony Clinical Research, Inc. | North Miami Beach | Florida | United States | 33162 |
| 19 | Palm Harbor Medical Associates | Palm Harbor | Florida | United States | 34684 |
| 20 | Andres Patron, D.O., P.A. | Pembroke Pines | Florida | United States | 33026 |
| 21 | Clinical Research of West Florida | Tampa | Florida | United States | 33603 |
| 22 | Perimeter Institute for Clinical Research PRIME | Atlanta | Georgia | United States | 30338 |
| 23 | Solaris Clinical Research | Meridian | Idaho | United States | 83646 |
| 24 | Chicago Research Center | Chicago | Illinois | United States | 60634 |
| 25 | American Health Network of Indiana, LLC | Avon | Indiana | United States | 46123 |
| 26 | Medisphere Medical Research Center, LLC | Evansville | Indiana | United States | 47714 |
| 27 | American Health Network of Indiana | Franklin | Indiana | United States | 46131 |
| 28 | American Health Network of Indiana, LLC | Muncie | Indiana | United States | 47304 |
| 29 | Bunyan Clinical Research | Valparaiso | Indiana | United States | 46383 |
| 30 | Crescent City Clinical Research Center | Metairie | Louisiana | United States | 70006 |
| 31 | Palm Research Center, Inc. | Las Vegas | Nevada | United States | 89148 |
| 32 | PMG Research of Charlotte, LLC | Charlotte | North Carolina | United States | 28209 |
| 33 | University of North Carolina at Chapel Hill | Durham | North Carolina | United States | 27713 |
| 34 | PMG Research of Salisbury, LLC | Salisbury | North Carolina | United States | 28144 |
| 35 | PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | United States | 27103 |
| 36 | Sentral Clinical Research Services, LLC | Cincinnati | Ohio | United States | 45236 |
| 37 | Columbus Clinical Research | Columbus | Ohio | United States | 43213 |
| 38 | Prestige Clinical Research | Franklin | Ohio | United States | 45005 |
| 39 | Lynn Institute of Norman | Norman | Oklahoma | United States | 73069 |
| 40 | Preferred Primary Care Physicians | Uniontown | Pennsylvania | United States | 15401 |
| 41 | Greer | South Carolina | United States | 29651 | |
| 42 | BMG The Endocrine Clinic | Memphis | Tennessee | United States | 38119 |
| 43 | Tekton Research, Inc. | Austin | Texas | United States | 78745 |
| 44 | 3rd Coast Research Associates | Corpus Christi | Texas | United States | 78414 |
| 45 | Dallas Diabetes and Endocrine Center | Dallas | Texas | United States | 75230 |
| 46 | Galena Research | Dallas | Texas | United States | 75251 |
| 47 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 48 | Medstar Clinical Research and Associates | Houston | Texas | United States | 77083 |
| 49 | Clinical Trials of Texas, Inc. | San Angelo | Texas | United States | 78229 |
| 50 | Sound Healthcare | Port Orchard | Washington | United States | 98366 |
| 51 | Ranier Clinical Research Center | Renton | Washington | United States | 98057 |
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:
NCT01785771
Other Study ID Numbers:
- ITCA 650-CLP-103-Sub-Study
First Posted:
Feb 7, 2013
Last Update Posted:
Mar 7, 2019
Last Verified:
Mar 1, 2019