Diabetes Metab J.  2011 Aug;35(4):411-417. 10.4093/dmj.2011.35.4.411.

Efficacy of Sitagliptin When Added to Ongoing Therapy in Korean Subjects with Type 2 Diabetes Mellitus

Affiliations
  • 1Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. leemk@skku.edu

Abstract

BACKGROUND
To evaluate the clinical efficacy of sitagliptin for reducing plasma glucose levels in Korean subjects with type 2 diabetes mellitus during a 14-week treatment period.
METHODS
Our study design involved the addition of 100 mg sitagliptin once-daily to three ongoing combination therapy regimens and changing from glimepiride and metformin to sitagliptin and metformin.
RESULTS
The addition of sitagliptin 100 mg/day produced a statistically significant reduction in mean HbA1c level (mean HbA1c reduction of 0.99+/-0.85%, P<0.01). In the group taking a combination of sitagliptin and metformin (n=143, initial mean HbA1c level=7.48%), the reductions in HbA1c, 2-hour postprandial glucose, and fasting glucose levels were 0.72+/-0.76% (P<0.01), 47+/-65 mg/dL (P<0.01), and 15+/-44 mg/dL (P<0.01), respectively. In the group taking a combination of sitagliptin, glimepiride, and metformin (n=125, initial mean HbA1c level=8.42%), the reductions in HbA1c, 2-hour postprandial glucose, and fasting glucose levels were 1.09+/-0.86% (P<0.01), 62+/-64 mg/dL (P<0.01), and 31+/-45 mg/dL (P<0.01), respectively. In the group taking a combination of sitagliptin, glimepiride, metformin, and alpha-glucosidase inhibitor (n=63, initial mean HbA1c level=9.19%), the reductions in HbA1c, 2-hour postprandial glucose, and fasting glucose levels were 1.27+/-0.70% (P<0.01), 72+/-65 mg/dL (P<0.01), and 35+/-51 mg/dL (P<0.01), respectively. In the group that had previous hypoglycemic events and that changed from glimepiride to sitagliptin, HbA1c level did not change but fasting glucose increased significantly (14+/-29 mg/dL, P<0.01).
CONCLUSION
Sitagliptin combination therapy for 14 weeks significantly improved glycemic control and was well-tolerated in Korean subjects with type 2 diabetes mellitus.

Keyword

Efficacy; Fasting plasma glucose; HbA1c; Sitagliptin; 2-hour postmeal glucose

MeSH Terms

alpha-Glucosidases
Diabetes Mellitus, Type 2
Fasting
Glucose
Metformin
Plasma
Pyrazines
Sulfonylurea Compounds
Triazoles
Sitagliptin Phosphate
Glucose
Metformin
Pyrazines
Sulfonylurea Compounds
Triazoles
alpha-Glucosidases

Figure

  • Fig. 1 Fasting C-peptide values after 14-weeks of addition of sitagliptin increased significantly from baseline (P<0.01). Paired t-test, aP value <0.01.

  • Fig. 2 Changes in HbA1c, fasting plasma glucose (FPG), and 2 hour-postprandial glucose (2h-PPG) values according to baseline C-peptide values were insignificant. (A) Changes in HbA1c according to baseline C-peptide. (B) Changes in FPG according to baseline C-peptide. (C) Changes in 2h-PPG according to baseline C-peptide. One-way ANOVA.

  • Fig. 3 Changes in HbA1c values according to baseline characteristics (age, gender, BMI) were insignificant. (A) Changes in HbA1c according to age. (B) Changes in HbA1c according to gender. (C) Changes in HbA1c according to BMI. One-way ANOVA. BMI, body mass index.


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