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Therapeutic Areas: Endocrinology | Family Medicine
Disease Category: Diabetes Mellitus, Type 2
Location: United States, CA
TECOS -DM II . A randomized, placebo controlled clinical Trial to Evaluate Cardiovascular Outcomes after treatment with Sitagliptin in patients with diabetes with inadequate glycemic control.
To compare the impact of including sitagliptin as part of usual care vs. usual care without sitagliptin on cardiovascular outcomes as measured by the time to first event in the primary cardiovascular composite endpoint of cardiovascualr related death, non fatal MI, nonfatal stroke unstable angina.
Patient Inclusion Criteria:
- Patient has type 2 DM with HgA1c of >6.5 % and 8.0% must be documented within 3 months prior to study enrollment.
- on a stable dose of insulin either alone or in combination with a stable dose of Metformin for at least 3 months.
- >50 years of age with preexisting vascular disease
Patient Exclusion Criteria:
- Patient has a history of type I diabetes or a history of ketoacidosis
- Patient has history of > 2 episodes of severe hypoglycemia
- patient has taken an approved investigational DPP-4 inhibitor agent
- Patient has cirrhosis of the liver
Nasra Hashmi, Clinical Research Specialist
Coastal Multi-Specialty Research
2621 S. Bristol St. Suite 108A
Santa Ana, CA 92704
Phone: 714-754-1684 x 30
If you would like to learn more about participating in this study, please send an email message using the form below.
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