Sitagliptin in Combination With Metformin and Sulfonylurea
Completed · Phase 4
Conditions studied: Type 2 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00686634
- Run by
- Charles Drew University of Medicine and Science
- People needed
- 108
- Starts
- 2008-01-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2014-11-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, age 18-75
- 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
You may not qualify if…
- Any contraindications to the use of metformin or a sulfonylurea agent
- 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.
Where it is running
- Charles Drew University of Medicine and Science — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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