Acarbose add-on therapy in patients with type 2 diabetes mellitus with metformin and sitagliptin failure: A multicenter, randomized, double-blind, placebo-controlled study

Hae Kyung Yang, Seung Hwan Lee, Juyoung Shin, Yoon Hee Choi, Yu Bae Ahn, Byung Wan Lee, Eun Jung Rhee, Kyung Wan Min, Kun Ho Yoon

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)287-301
Number of pages15
JournalDiabetes and Metabolism Journal
Volume43
Issue number3
DOIs
Publication statusPublished - 2019 Jun 1

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Acarbose
Metformin
Type 2 Diabetes Mellitus
Placebos
Therapeutics
Glucagon
Sitagliptin Phosphate
Glycosylated Hemoglobin A
Korea
Hyperglycemia
Area Under Curve
Meals
Carbohydrates
Insulin
Safety
Incidence

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism

Cite this

Yang, Hae Kyung ; Lee, Seung Hwan ; Shin, Juyoung ; Choi, Yoon Hee ; Ahn, Yu Bae ; Lee, Byung Wan ; Rhee, Eun Jung ; Min, Kyung Wan ; Yoon, Kun Ho. / Acarbose add-on therapy in patients with type 2 diabetes mellitus with metformin and sitagliptin failure : A multicenter, randomized, double-blind, placebo-controlled study. In: Diabetes and Metabolism Journal. 2019 ; Vol. 43, No. 3. pp. 287-301.
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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.",
author = "Yang, {Hae Kyung} and Lee, {Seung Hwan} and Juyoung Shin and Choi, {Yoon Hee} and Ahn, {Yu Bae} and Lee, {Byung Wan} and Rhee, {Eun Jung} and Min, {Kyung Wan} and Yoon, {Kun Ho}",
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Acarbose add-on therapy in patients with type 2 diabetes mellitus with metformin and sitagliptin failure : A multicenter, randomized, double-blind, placebo-controlled study. / Yang, Hae Kyung; Lee, Seung Hwan; Shin, Juyoung; Choi, Yoon Hee; Ahn, Yu Bae; Lee, Byung Wan; Rhee, Eun Jung; Min, Kyung Wan; Yoon, Kun Ho.

In: Diabetes and Metabolism Journal, Vol. 43, No. 3, 01.06.2019, p. 287-301.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Acarbose add-on therapy in patients with type 2 diabetes mellitus with metformin and sitagliptin failure

T2 - A multicenter, randomized, double-blind, placebo-controlled study

AU - Yang, Hae Kyung

AU - Lee, Seung Hwan

AU - Shin, Juyoung

AU - Choi, Yoon Hee

AU - Ahn, Yu Bae

AU - Lee, Byung Wan

AU - Rhee, Eun Jung

AU - Min, Kyung Wan

AU - Yoon, Kun Ho

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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.

AB - 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.

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