Sitagliptin in Combination With Metformin and Sulfonylurea
NCT ID: NCT00686634
Last Updated: 2014-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
108 participants
INTERVENTIONAL
2008-01-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Sitagliptin 100 mg once daily
Sitagliptin
Sitagliptin 100 mg by mouth once daily
Interventions
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Sitagliptin
Sitagliptin 100 mg by mouth once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes
* At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (Hemoglobin A1c (HbA1c) \>7.0%)
* Able to comply with all scheduled visits and requirements of the protocol
Exclusion Criteria
* Extreme hyperglycemia or symptoms of polyuria or polydipsia
* Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
* History of confirmed (or clinical suspicion of) type 1 diabetes mellitus
* Episodes of symptomatic hypoglycemia averaging greater than once per day
* Estimated glomerular filtration rate (eGFR) \< 60 mL/min
* Subjects with active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c unreliable
* History of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.
* Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
* Current pregnancy or lactation.
* Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.
* Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
* Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
18 Years
75 Years
ALL
No
Sponsors
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National Center for Research Resources (NCRR)
NIH
Charles Drew University of Medicine and Science
OTHER
Responsible Party
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Principal Investigators
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Stanley Hsia, MD
Role: PRINCIPAL_INVESTIGATOR
Charles Drew University of Medicine and Science
Locations
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Charles Drew University of Medicine and Science
Los Angeles, California, United States
Countries
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References
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Hsia SH, Navar MD, Duran P, Shaheen M, Davidson MB. Sitagliptin compared with thiazolidinediones as a third-line oral antihyperglycemic agent in type 2 diabetes mellitus. Endocr Pract. 2011 Sep-Oct;17(5):691-8. doi: 10.4158/EP10405.OR.
Other Identifiers
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07-06-002
Identifier Type: -
Identifier Source: org_study_id