Abstract | AIMS/INTRODUCTION: MATERIALS AND METHODS: The present study had an initial 12-week, double-blind treatment period in which patients were randomized (1:1) to sitagliptin 50 mg/day (n = 70) or placebo (n = 63), followed by a 40-week, open-label treatment period during which all patients received sitagliptin 50 mg/day, that could have been increased to 100 mg/day for patients meeting predefined glycemic criteria. RESULTS: After 12 weeks, treatment with sitagliptin resulted in placebo-subtracted mean changes from baseline in glycated hemoglobin (the primary end-point), fasting plasma glucose and 2-h postmeal glucose of -0.9%, -22.5 mg/dL and -51.3 mg/dL, respectively (all, P < 0.001). During the double-blind period, adverse experiences were reported with similar frequency in both treatment groups, and the occurrences of hypoglycemia and gastrointestinal adverse experiences were low. In the open-label period, sustained improvements in glycemic parameters were observed with sitagliptin treatment, and sitagliptin was generally well tolerated. CONCLUSIONS:
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Authors | Naoko Tajima, Takashi Kadowaki, Taro Okamoto, Asako Sato, Kotoba Okuyama, Toshiomi Minamide, Juan Camilo Arjona Ferreira |
Journal | Journal of diabetes investigation
(J Diabetes Investig)
Vol. 4
Issue 6
Pg. 595-604
(Nov 27 2013)
ISSN: 2040-1116 [Print] Japan |
PMID | 24843714
(Publication Type: Journal Article)
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