Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- Author:
Tae Jung OH
1
;
Jae Myung YU
;
Kyung Wan MIN
;
Hyun Shik SON
;
Moon Kyu LEE
;
Kun Ho YOON
;
Young Duk SONG
;
Joong Yeol PARK
;
In Kyung JEONG
;
Bong Soo CHA
;
Yong Seong KIM
;
Sei Hyun BAIK
;
In Joo KIM
;
Doo Man KIM
;
Sung Rae KIM
;
Kwan Woo LEE
;
Jeong Hyung PARK
;
In Kyu LEE
;
Tae Sun PARK
;
Sung Hee CHOI
;
Sung Woo PARK
Author Information
- Publication Type:Randomized Controlled Trial
- Keywords: Diabetes mellitus, type 2; Metformin; Voglibose
- MeSH: Blood Glucose; Diabetes Mellitus, Type 2; Fasting; Glucose; Hemoglobin A, Glycosylated; Humans; Hypoglycemia; Metformin; Weight Loss
- From:Diabetes & Metabolism Journal 2019;43(3):276-286
- CountryRepublic of Korea
- Language:English
- Abstract: BACKGROUND: Combination of metformin to reduce the fasting plasma glucose level and an α-glucosidase inhibitor to decrease the postprandial glucose level is expected to generate a complementary effect. We compared the efficacy and safety of a fixed-dose combination of voglibose plus metformin (vogmet) with metformin monotherapy in drug-naïve newly-diagnosed type 2 diabetes mellitus. METHODS: A total of 187 eligible patients aged 20 to 70 years, with a glycosylated hemoglobin (HbA1c) level of 7.0% to 11.0%, were randomized into either vogmet or metformin treatments for 24 weeks. A change in the HbA1c level from baseline was measured at week 24. RESULTS: The reduction in the levels of HbA1c was −1.62%±0.07% in the vogmet group and −1.31%±0.07% in the metformin group (P=0.003), and significantly more vogmet-treated patients achieved the target HbA1c levels of <6.5% (P=0.002) or <7% (P=0.039). Glycemic variability was also significantly improved with vogmet treatment, estimated by M-values (P=0.004). Gastrointestinal adverse events and hypoglycemia (%) were numerically lower in the vogmet-treated group. Moreover, a significant weight loss was observed with vogmet treatment compared with metformin (−1.63 kg vs. −0.86 kg, P=0.039). CONCLUSION: Vogmet is a safe antihyperglycemic agent that controls blood glucose level effectively, yields weight loss, and is superior to metformin in terms of various key glycemic parameters without increasing the risk of hypoglycemia.
