A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
Public ClinicalTrials.gov record NCT00631007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of INT131 Besylate Compared to Pioglitazone in Subjects With Type 2 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.
Study identification
- NCT ID
- NCT00631007
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 367 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2008
- Primary completion
- Jul 31, 2009
- Completion
- Aug 31, 2009
- Last update posted
- Sep 12, 2010
2008 – 2009
United States locations
- U.S. sites
- 59
- U.S. states
- 23
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northern California Research | Carmichael | California | 95608 | — |
| National Research Institute | Los Angeles | California | 90057 | — |
| VA San Diego Healthcare System | San Diego | California | 92161 | — |
| Apex Research Institute | Santa Ana | California | 92705 | — |
| Internal Medicine of the Rockies | Colorado Springs | Colorado | 80910 | — |
| Creekside Endocrine Associates, PC | Denver | Colorado | 80209 | — |
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | — |
| MedStar Research Institute | Washington D.C. | District of Columbia | 20003 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| The Center for Diabetes and Endocrine Care | Hollywood | Florida | 33021 | — |
| Baptist Diabetes Associates, PA | Miami | Florida | 33156 | — |
| International Research Associates, LLC | Miami | Florida | 33156 | — |
| Elite Research Institute | Miami | Florida | 33169 | — |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | — |
| Suncoast Clinical Research, Inc. | Palm Harbor | Florida | 34652 | — |
| Meridien Research | Tampa | Florida | 33606 | — |
| Meridien Research | Tampa | Florida | 34203 | — |
| Clinical Research of Central Florida | Winter Haven | Florida | 33880 | — |
| Executive Health and Research Associates, Inc. | Atlanta | Georgia | 30342 | — |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | — |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | — |
| ICCT Reseach International | Chicago | Illinois | 60611 | — |
| American Health Network | Indianapolis | Indiana | 46254 | — |
| L-Marc Research Center | Louisville | Kentucky | 40213 | — |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | — |
| Stephen R. Smith, MD | Baltimore | Maryland | 21234 | — |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | — |
| Diabetes and Endocrinology Specialists, Inc. | Chesterfield | Missouri | 63017 | — |
| Saint Luke's Lipid and Diabetes Reseach Center | Kansas City | Missouri | 64111 | — |
| Bozeman Deaconess Internal Medicine Associates | Bozeman | Montana | 59715 | — |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | — |
| Kaleida Health Diabetes Center | Buffalo | New York | 14209 | — |
| UNC Diabetes Care Center/Highgate Specialty Center | Durham | North Carolina | 27713 | — |
| Fairbrook Medical Clinic | Hickory | North Carolina | 28602 | — |
| Diabetes & Endrocrinology Consultants | Morehead City | North Carolina | 28557 | — |
| The Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | — |
| IVA Research | Cincinnati | Ohio | 45245 | — |
| Rapid Medical Research, Inc | Cleveland | Ohio | 44122 | — |
| Opitmed Research, LTD | Columbus | Ohio | 43235 | — |
| ResEvo LLC | Cuyahoga Falls | Ohio | 44223 | — |
| Delaware Smith Clinic | Delaware | Ohio | 43015 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Wells Institute for Health Awareness | Kettering | Ohio | 45429 | — |
| Frederick C Smith Clinic | Marion | Ohio | 43302 | — |
| Your Diabetes Endocrine Nutrition Group, LLC | Mentor | Ohio | 44060 | — |
| Clinical Research Source, Inc | Perrysburg | Ohio | 43551 | — |
| Tri-State Medical Group, Inc. | Beaver | Pennsylvania | 15009 | — |
| Lycoming Internal Medicine, Inc. | Jersey Shore | Pennsylvania | 17740 | — |
| New England Center for Clinical Research | Cranston | Rhode Island | 02920 | — |
| Hartwell Research Group | Anderson | South Carolina | 29621 | — |
| Medical Research South | Charleston | South Carolina | 29407 | — |
| Palmetto Clinical Trial Services, LLC | Simpsonville | South Carolina | 29681 | — |
| Dallas Diabetes and Endocrine Research Center | Dallas | Texas | 75230 | — |
| Research Institute of Dallas | Dallas | Texas | 75231 | — |
| Baylor University Endocrine Center | Dallas | Texas | 75246 | — |
| Diabetes Center of the Southwest | Midland | Texas | 79705 | — |
| Quality Research, Inc. | San Antonio | Texas | 78209 | — |
| DGD Research | San Antonio | Texas | 78229 | — |
| Salem VA Medical Center R&D Office | Salem | Virginia | 24153 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00631007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 12, 2010 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00631007 live on ClinicalTrials.gov.