Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
- Author:
Hae Kyung YANG
1
;
Seung Hwan LEE
;
Juyoung SHIN
;
Yoon Hee CHOI
;
Yu Bae AHN
;
Byung Wan LEE
;
Eun Jung RHEE
;
Kyung Wan MIN
;
Kun Ho YOON
Author Information
- Publication Type:Multicenter Study
- Keywords: Acarbose; Diabetes mellitus, type 2; Drug therapy, combination; Metformin; Sitagliptin phosphate
- MeSH: Acarbose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glucagon; Hemoglobin A, Glycosylated; Humans; Hyperglycemia; Incidence; Insulin; Korea; Meals; Metformin; Sitagliptin Phosphate
- From:Diabetes & Metabolism Journal 2019;43(3):287-301
- CountryRepublic of Korea
- Language:English
- Abstract: BACKGROUND: We evaluated the efficacy and safety of acarbose add-on therapy in Korean patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with metformin and sitagliptin. METHODS: A total of 165 subjects were randomized to metformin and sitagliptin (Met+Sita, n=65), metformin, sitagliptin, and acarbose (Met+Sita+Acarb, n=66) and sitagliptin and acarbose (Sita+Acarb, exploratory assessment, n=34) therapy in five institutions in Korea. After 16 weeks of acarbose add-on or metformin-switch therapy, a triple combination therapy was maintained from week 16 to 24. RESULTS: The add-on of acarbose (Met+Sita+Acarb group) demonstrated a 0.44%±0.08% (P<0.001 vs. baseline) decrease in glycosylated hemoglobin (HbA1c) at week 16, while changes in HbA1c were insignificant in the Met+Sita group (−0.09%±0.10%, P=0.113). After 8 weeks of triple combination therapy, HbA1c levels were comparable between Met+Sita and Met+Sita+Acarb group (7.66%±0.13% vs. 7.47%±0.12%, P=0.321). Acarbose add-on therapy demonstrated suppressed glucagon secretion (area under the curve of glucagon, 4,726.17±415.80 ng·min/L vs. 3,314.38±191.63 ng·min/L, P=0.004) in the absence of excess insulin secretion during the meal tolerance tests at week 16 versus baseline. The incidence of adverse or serious adverse events was similar between two groups. CONCLUSION: In conclusion, a 16-week acarbose add-on therapy to metformin and sitagliptin, effectively lowered HbA1c without significant adverse events. Acarbose might be a good choice as a third-line therapy in addition to metformin and sitagliptin in Korean subjects with T2DM who have predominant postprandial hyperglycemia and a high carbohydrate intake.
