--- title: A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus nct_id: NCT00952445 overall_status: COMPLETED phase: PHASE2 sponsor: InteKrin Therapeutics, Inc. study_type: INTERVENTIONAL primary_condition: Diabetes Mellitus, Type II countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00952445.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00952445" ct_last_update_post_date: 2022-10-19 last_seen_at: "2026-05-12T07:12:28.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus **Official Title:** A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus **NCT ID:** [NCT00952445](https://clinicaltrials.gov/study/NCT00952445) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 70 - **Lead Sponsor:** InteKrin Therapeutics, Inc. - **Conditions:** Diabetes Mellitus, Type II - **Start Date:** 2003-12 - **Completion Date:** 2004-06 - **CT.gov Last Update:** 2022-10-19 ## Brief Summary The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus. ## Eligibility - **Minimum age:** 30 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment * Fasting Plasma Glucose between 126 and 240 mg/dL * Hemoglobin-A1c (HbA1c) between 6.8% and 10.0% * Fasting C-peptide \> 0.8 ng/mL Exclusion Criteria: * Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening * Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone * BMI \> 42 kg/m2 * Presence of any diabetic complications requiring chronic therapy * Presence or history of any form of hepatic disease * Serum creatinine \> 1.8 mg/dL * History of cardiac arrhythmias or abnormal cardiac electrophysiology * Any reason that, in the Investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol ``` ## Arms - **T0903131 Besylate** (EXPERIMENTAL) — 1.0 mg - **T0903131 Besylate (higher dose)** (EXPERIMENTAL) — 10.0 mg - **Placebo** (PLACEBO_COMPARATOR) — Once daily, oral ## Interventions - **T0903131 Besylate** (DRUG) — Once daily, oral - **Placebo** (DRUG) — Once daily, oral ## Locations (21) - Whittier Diabetes Institute, La Jolla, California, United States - Charles R. Drew University, Los Angeles, California, United States - National Research Institute, Los Angeles, California, United States - Lovelace Research Institute, Santa Ana, California, United States - University of Miami, Miami, Florida, United States - GFI Research Center, Evansville, Indiana, United States - Joslin Diabetes Center, Boston, Massachusetts, United States - Radiant Research, Edina, Minnesota, United States - Radiant Research, St Louis, Missouri, United States - St Louis Center for Clinical Research, St Louis, Missouri, United States - Kaleida Health Diabetes Center, Buffalo, New York, United States - Rochester Clinical Research, Rochester, New York, United States - Duke University Medical Center, Durham, North Carolina, United States - Radiant Research, Portland, Oregon, United States - Radiant Research, Anderson, South Carolina, United States - Baylor University Endocrine Center, Dallas, Texas, United States - Dallas Diabetes and Endocrine Research Center, Dallas, Texas, United States - Endocrine Associates of Dallas, Dallas, Texas, United States - Diabetes and Grandular Disease Clinic and Reseach Center, San Antonio, Texas, United States - Endocrine Research Specialists, Ogden, Utah, United States - Salem VA Medical Center, Salem, Virginia, United States ## Recent Field Changes (last 30 days) - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.rochester clinical research|rochester|new york|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.whittier diabetes institute|la jolla|california|united states` — added _(2026-05-12)_ - `locations.charles r. drew university|los angeles|california|united states` — added _(2026-05-12)_ - `locations.national research institute|los angeles|california|united states` — added _(2026-05-12)_ - `locations.lovelace research institute|santa ana|california|united states` — added _(2026-05-12)_ - `locations.university of miami|miami|florida|united states` — added _(2026-05-12)_ - `locations.gfi research center|evansville|indiana|united states` — added _(2026-05-12)_ - `locations.joslin diabetes center|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.radiant research|edina|minnesota|united states` — added _(2026-05-12)_ - `locations.radiant research|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.st louis center for clinical research|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.kaleida health diabetes center|buffalo|new york|united states` — added _(2026-05-12)_ - `locations.duke university medical center|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.radiant research|portland|oregon|united states` — added _(2026-05-12)_ - `locations.radiant research|anderson|south carolina|united states` — added _(2026-05-12)_ - `locations.baylor university endocrine center|dallas|texas|united states` — added _(2026-05-12)_ - `locations.dallas diabetes and endocrine research center|dallas|texas|united states` — added _(2026-05-12)_ - `locations.endocrine associates of dallas|dallas|texas|united states` — added _(2026-05-12)_ - `locations.diabetes and grandular disease clinic and reseach center|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.endocrine research specialists|ogden|utah|united states` — added _(2026-05-12)_ - `locations.salem va medical center|salem|virginia|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00952445.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00952445* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*