Weiqing Wang1, Guang Ning1, Jianhua Ma2, Xiaomin Liu3, Shaoxiong Zheng4, Fan Wu5,6, Lei Xu5, Edward A O'Neill5, Kenji P Fujita5,7, Samuel S Engel5, Keith D Kaufman5, R Ravi Shankar5. 1. a Ruijin Hospital, School of Medicine, Shanghai Jiaotong University , Shanghai , China. 2. b Nanjing First Hospital Affiliated to Nanjing Medical University , Nanjing , China. 3. c The First Affiliated Hospital of Harbin Medical University , Heilongjiang , China. 4. d The Second Hospital of Tianjin Medical University , Tianjin , China. 5. e Merck & Co., Inc. , Kenilworth , NJ , USA. 6. f Current address: Roche (China) Holding Ltd. , Beijing , China. 7. g Current address: Alexion Pharmaceuticals , New Haven , CT , USA.
Abstract
OBJECTIVE: To evaluate the safety and efficacy of sitagliptin when added to the treatment of patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on acarbose monotherapy. RESEARCH DESIGN AND METHODS: This was a multicenter, randomized, placebo-controlled, double-blind clinical trial. Patients (N = 381) with T2DM and inadequate glycemic control (glycated hemoglobin [HbA1c] ≥ 7.0% and ≤10.0%) on acarbose monotherapy (at least 50 mg three times daily) were randomized in a 1:1 ratio to receive the addition of sitagliptin 100 mg or matching placebo once daily for 24 weeks. MAIN OUTCOME MEASURES: Changes from baseline in HbA1c and fasting plasma glucose (FPG) at Week 24. RESULTS: The mean baseline HbA1c in randomized patients was 8.1%. At Week 24, the placebo-controlled, least squares mean changes from baseline (95% confidence interval) in HbA1c and FPG in the sitagliptin group were -0.62% and -0.8 mmol/L (p < .001), respectively. At Week 24, 37.8% of patients in the sitagliptin group were at HbA1c goal of <7% compared with 17.2% in the placebo group (p < .001). Sitagliptin was generally well tolerated, and there were no significant between-group differences in prespecified safety parameters (symptomatic hypoglycemia, diarrhea, abdominal pain, nausea, vomiting). A higher incidence of serious adverse events was observed in the sitagliptin group (5.2%) relative to placebo (0.5%); all but one, in the sitagliptin group, were not considered related to drug. CONCLUSIONS:Sitagliptin was generally well tolerated and provided statistically superior and clinically meaningful improvements in glycemic control after 24 weeks of treatment compared to placebo when added to treatment of patients with inadequate glycemic control on acarbose monotherapy. Clinicaltrials.gov: NCT01177384.
RCT Entities:
OBJECTIVE: To evaluate the safety and efficacy of sitagliptin when added to the treatment of patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on acarbose monotherapy. RESEARCH DESIGN AND METHODS: This was a multicenter, randomized, placebo-controlled, double-blind clinical trial. Patients (N = 381) with T2DM and inadequate glycemic control (glycated hemoglobin [HbA1c] ≥ 7.0% and ≤10.0%) on acarbose monotherapy (at least 50 mg three times daily) were randomized in a 1:1 ratio to receive the addition of sitagliptin 100 mg or matching placebo once daily for 24 weeks. MAIN OUTCOME MEASURES: Changes from baseline in HbA1c and fasting plasma glucose (FPG) at Week 24. RESULTS: The mean baseline HbA1c in randomized patients was 8.1%. At Week 24, the placebo-controlled, least squares mean changes from baseline (95% confidence interval) in HbA1c and FPG in the sitagliptin group were -0.62% and -0.8 mmol/L (p < .001), respectively. At Week 24, 37.8% of patients in the sitagliptin group were at HbA1c goal of <7% compared with 17.2% in the placebo group (p < .001). Sitagliptin was generally well tolerated, and there were no significant between-group differences in prespecified safety parameters (symptomatic hypoglycemia, diarrhea, abdominal pain, nausea, vomiting). A higher incidence of serious adverse events was observed in the sitagliptin group (5.2%) relative to placebo (0.5%); all but one, in the sitagliptin group, were not considered related to drug. CONCLUSIONS:Sitagliptin was generally well tolerated and provided statistically superior and clinically meaningful improvements in glycemic control after 24 weeks of treatment compared to placebo when added to treatment of patients with inadequate glycemic control on acarbose monotherapy. Clinicaltrials.gov: NCT01177384.
Authors: Sushrima Gan; Adem Y Dawed; Louise A Donnelly; Anand T N Nair; Colin N A Palmer; Viswanathan Mohan; Ewan R Pearson Journal: Diabetes Care Date: 2020-08 Impact factor: 19.112
Authors: Linong Ji; Juliana C N Chan; Miao Yu; Kun Ho Yoon; Sin Gon Kim; Sung Hee Choi; Chien-Ning Huang; Shih Te Tu; Chih-Yuan Wang; Päivi Maria Paldánius; Wayne H H Sheu Journal: Diabetes Obes Metab Date: 2020-11-09 Impact factor: 6.577