Sang Soo Kim1,2, In Joo Kim1,2, Kwang Jae Lee3, Jeong Hyun Park4, Young Il Kim5, Young Sil Lee6, Sung Chang Chung7, Sang Jin Lee8. 1. Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea. 2. Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea. 3. Division of Endocrinology and Metabolism, Department of Internal Medicine, Daedong Hospital, Busan, South Korea. 4. Division of Endocrinology and Metabolism, Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea. 5. Division of Endocrinology and Metabolism, Department of Internal Medicine, Ulsan University Hospital, Ulsan, South Korea. 6. Division of Endocrinology and Metabolism, Department of Internal Medicine, Dongguk University School of Medicine, Gyeongju, South Korea. 7. Division of Endocrinology and Metabolism, Department of Internal Medicine, Dongkang Medical Center, Ulsan, South Korea. 8. MSD Korea Ltd, Seoul, South Korea.
Abstract
BACKGROUND: Early initiation of combination therapy using antihyperglycemic agents is recommended for treating type 2 diabetes (T2D). The present multicenter double-blind randomized parallel-group study examined the efficacy and safety of a sitagliptin and metformin fixed-dose combination (Sita/Met) compared with glimepiride in T2D patients as initial treatment. METHODS:Type 2 diabetes patients (aged ≥18 years) were randomized to Sita/Met or glimepiride for 30 weeks after a wash-off run-in period. The primary endpoint was change from baseline (CFB) in HbA1c. Secondary endpoints included the proportion of patients achieving target goal (HbA1c < 7.0 % [53 mmol/mol]) and CFB in fasting plasma glucose (FPG). Safety assessments comprised weight gain from baseline and the incidence of adverse events (AEs). RESULTS: In total, 292 patients were randomized to Sita/Met (n = 147) or glimepiride (n = 145). After 30 weeks, Sita/Met demonstrated superiority over glimepiride in reducing HbA1c (-1.49 % vs -0.71 %, respectively; between-group difference - 0.78 %; P < 0.001). A significantly higher proportion of patients achieved the target goal with Sita/Met (81.2 %) than with glimepiride (40.1 %; P < 0.001). Greater reduction in FPG occurred with Sita/Met than with glimepiride (least-squares mean difference - 23.5 mg/dL; P < 0.001). Both drugs were generally well tolerated. Hypoglycemia events and weight gain were significantly lower in patients with Sita/Met than with glimepiride (5.5 % vs 20.1 % and -0.83 vs +0.90 kg, respectively; both P < 0.001). No serious drug-related AEs or deaths were reported. CONCLUSIONS: Compared with glimepiride, Sita/Met as an initial treatment led to significantly greater improvements in glycemic control and body weight changes, with a lower incidence of hypoglycemia, over 30 weeks.
RCT Entities:
BACKGROUND: Early initiation of combination therapy using antihyperglycemic agents is recommended for treating type 2 diabetes (T2D). The present multicenter double-blind randomized parallel-group study examined the efficacy and safety of a sitagliptin and metformin fixed-dose combination (Sita/Met) compared with glimepiride in T2D patients as initial treatment. METHODS:Type 2 diabetespatients (aged ≥18 years) were randomized to Sita/Met or glimepiride for 30 weeks after a wash-off run-in period. The primary endpoint was change from baseline (CFB) in HbA1c. Secondary endpoints included the proportion of patients achieving target goal (HbA1c < 7.0 % [53 mmol/mol]) and CFB in fasting plasma glucose (FPG). Safety assessments comprised weight gain from baseline and the incidence of adverse events (AEs). RESULTS: In total, 292 patients were randomized to Sita/Met (n = 147) or glimepiride (n = 145). After 30 weeks, Sita/Met demonstrated superiority over glimepiride in reducing HbA1c (-1.49 % vs -0.71 %, respectively; between-group difference - 0.78 %; P < 0.001). A significantly higher proportion of patients achieved the target goal with Sita/Met (81.2 %) than with glimepiride (40.1 %; P < 0.001). Greater reduction in FPG occurred with Sita/Met than with glimepiride (least-squares mean difference - 23.5 mg/dL; P < 0.001). Both drugs were generally well tolerated. Hypoglycemia events and weight gain were significantly lower in patients with Sita/Met than with glimepiride (5.5 % vs 20.1 % and -0.83 vs +0.90 kg, respectively; both P < 0.001). No serious drug-related AEs or deaths were reported. CONCLUSIONS: Compared with glimepiride, Sita/Met as an initial treatment led to significantly greater improvements in glycemic control and body weight changes, with a lower incidence of hypoglycemia, over 30 weeks.
Authors: Jun Sung Moon; Sunghwan Suh; Sang Soo Kim; Heung Yong Jin; Jeong Mi Kim; Min Hee Jang; Kyung Ae Lee; Ju Hyung Lee; Seung Min Chung; Young Sang Lyu; Jin Hwa Kim; Sang Yong Kim; Jung Eun Jang; Tae Nyun Kim; Sung Woo Kim; Eonju Jeon; Nan Hee Cho; Mi-Kyung Kim; Hye Soon Kim; Il Seong Nam-Goong; Eun Sook Kim; Jin Ook Chung; Dong-Hyeok Cho; Chang Won Lee; Young Il Kim; Dong Jin Chung; Kyu Chang Won; In Joo Kim; Tae Sun Park; Duk Kyu Kim; Hosang Shon Journal: Diabetes Metab J Date: 2020-08-12 Impact factor: 5.376