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Sponsors and Collaborators: |
Charles Drew University of Medicine and Science National Institutes of Health (NIH) |
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Information provided by: | Charles Drew University of Medicine and Science |
ClinicalTrials.gov Identifier: | NCT00686634 |
This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Sitagliptin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Sitagliptin in Combination Oral Agent Therapy for Type 2 Diabetes |
Estimated Enrollment: | 100 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Sitagliptin 100 mg once daily
|
Drug: Sitagliptin
Sitagliptin 100 mg po once daily
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The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maria Navar, NP | 310-668-3610 | m.d.navar@sbcglobal.com |
United States, California | |
Charles Drew University of Medicine and Science | Recruiting |
Los Angeles, California, United States, 90059 | |
Principal Investigator: Stanley Hsia, MD | |
Sub-Investigator: Mayer Davidson, MD |
Principal Investigator: | Stanley Hsia, MD | Charles Drew University of Medicine and Science |
Responsible Party: | Charles Drew University of Medicine and Science ( Stanley Hsia, MD ) |
Study ID Numbers: | 07-06-002 |
Study First Received: | May 27, 2008 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00686634 |
Health Authority: | United States: Institutional Review Board |
sitagliptin type 2 diabetes combination therapy |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |