A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
InteKrin Therapeutics, Inc.
Information provided by:
InteKrin Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00952445
First received: August 4, 2009
Last updated: August 5, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type II |
Drug: T0903131 Besylate Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by InteKrin Therapeutics, Inc.:
| Enrollment: | 70 |
| Study Start Date: | December 2003 |
| Study Completion Date: | June 2004 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: T0903131 Besylate
1.0 mg
|
Drug: T0903131 Besylate
Once daily, oral
Other Name: INT131 Besylate
|
|
Experimental: T0903131 Besylate
10.0 mg
|
Drug: T0903131 Besylate
Once daily, oral
Other Name: INT131 Besylate
|
|
Placebo Comparator: Placebo
Once daily, oral
|
Drug: Placebo
Once daily, oral
|
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952445
Locations
| United States, California | |
| Whittier Diabetes Institute | |
| La Jolla, California, United States | |
| National Research Institute | |
| Los Angeles, California, United States | |
| Charles R. Drew University | |
| Los Angeles, California, United States | |
| Lovelace Research Institute | |
| Santa Ana, California, United States | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States | |
| United States, Indiana | |
| GFI Research Center | |
| Evansville, Indiana, United States | |
| United States, Massachusetts | |
| Joslin Diabetes Center | |
| Boston, Massachusetts, United States | |
| United States, Minnesota | |
| Radiant Research | |
| Edina, Minnesota, United States | |
| United States, Missouri | |
| St Louis Center for Clinical Research | |
| St. Louis, Missouri, United States | |
| Radiant Research | |
| St. Louis, Missouri, United States | |
| United States, New York | |
| Kaleida Health Diabetes Center | |
| Buffalo, New York, United States | |
| Rochester Clinical Research | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States | |
| United States, Oregon | |
| Radiant Research | |
| Portland, Oregon, United States | |
| United States, South Carolina | |
| Radiant Research | |
| Anderson, South Carolina, United States | |
| United States, Texas | |
| 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 | |
| United States, Utah | |
| Endocrine Research Specialists | |
| Ogden, Utah, United States | |
| United States, Virginia | |
| Salem VA Medical Center | |
| Salem, Virginia, United States | |
Sponsors and Collaborators
InteKrin Therapeutics, Inc.
More Information
No publications provided by InteKrin Therapeutics, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00952445 History of Changes |
| Other Study ID Numbers: | T-131-004 |
| Study First Received: | August 4, 2009 |
| Last Updated: | August 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013