Jian Zhou1, Fenping Zheng2, Xiaohui Guo3, Huazhang Yang4, Muxun Zhang5, Haoming Tian6, Lixin Guo7, Qiang Li8, Yifei Mo1, Weiping Jia1. 1. Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Key Clinical Center for Metabolic Disease, Shanghai, China. 2. Department of Endocrinology and Metabolism, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China. 3. Department of Endocrinology and Metabolism, Peking University First Hospital, Beijing, China. 4. Department of Endocrinology and Metabolism, Guangdong General Hospital, Guangzhou, Guangdong, China. 5. Department of Endocrinology and Metabolism, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China. 6. Department of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, China. 7. Department of Endocrinology and Metabolism, Beijing Hospital of Ministry of Public Health, Beijing, China. 8. Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
Abstract
BACKGROUND: The aim of this study is to compare the efficacy and safety of once-daily insulin glargine plus gliclazide modified release combination therapy versus twice-daily premixed insulin monotherapy in Chinese type 2 diabetic patients insufficiently controlled by oral antidiabetic agents. METHODS: In a 12-week, multicenter, randomized, parallel-group clinical trial, patients with poor glycaemic control (fasting plasma glucose ≥ 7.0 mmol/L and 7.5% < haemoglobin A1c ≤ 10%) on oral antidiabetic drugs were randomized to the treatment groups for combination therapy (n = 52) or monotherapy (n = 53). Continuous glucose monitoring was carried out over two 72-h periods, at the beginning and the end of the study, and the data were used to calculate the 24-h mean blood glucose, mean amplitude of glycaemic excursions, standard deviation of blood glucose, and the mean of daily differences. RESULTS: The mean haemoglobin A1c decrease from baseline to study end was significant for both treatment groups (combination therapy: -1.23 ± 0.92%; insulin monotherapy: -1.02 ± 1.04%); moreover, the combination therapy group showed a significantly more robust haemoglobin A1c decrease (p = 0.0308). Both therapies significantly reduced the 24-h mean blood glucose (both, p < 0.001), but neither produced a significant effect on glycaemic variability, calculated as mean amplitude of glycaemic excursions, standard deviation of blood glucose, and mean of daily differences. In addition, the effects on rates of hypoglycaemic episodes were similar between the two therapies. CONCLUSIONS:Chinese patients with type 2 diabetes inadequately controlled withoral antidiabetic agents attained greater benefit from once-daily insulin glargine plus gliclazide modified release regimen than from a twice-daily premixed insulin regimen.
RCT Entities:
BACKGROUND: The aim of this study is to compare the efficacy and safety of once-daily insulin glargine plus gliclazide modified release combination therapy versus twice-daily premixed insulin monotherapy in Chinese type 2 diabeticpatientsinsufficiently controlled by oral antidiabetic agents. METHODS: In a 12-week, multicenter, randomized, parallel-group clinical trial, patients with poor glycaemic control (fasting plasma glucose ≥ 7.0 mmol/L and 7.5% < haemoglobin A1c ≤ 10%) on oral antidiabetic drugs were randomized to the treatment groups for combination therapy (n = 52) or monotherapy (n = 53). Continuous glucose monitoring was carried out over two 72-h periods, at the beginning and the end of the study, and the data were used to calculate the 24-h mean blood glucose, mean amplitude of glycaemic excursions, standard deviation of blood glucose, and the mean of daily differences. RESULTS: The mean haemoglobin A1c decrease from baseline to study end was significant for both treatment groups (combination therapy: -1.23 ± 0.92%; insulin monotherapy: -1.02 ± 1.04%); moreover, the combination therapy group showed a significantly more robust haemoglobin A1c decrease (p = 0.0308). Both therapies significantly reduced the 24-h mean blood glucose (both, p < 0.001), but neither produced a significant effect on glycaemic variability, calculated as mean amplitude of glycaemic excursions, standard deviation of blood glucose, and mean of daily differences. In addition, the effects on rates of hypoglycaemic episodes were similar between the two therapies. CONCLUSIONS: Chinese patients with type 2 diabetes inadequately controlled with oral antidiabetic agents attained greater benefit from once-daily insulin glargine plus gliclazide modified release regimen than from a twice-daily premixed insulin regimen.
Authors: Sanjay Kalra; Silver Bahendeka; Rakesh Sahay; Sujoy Ghosh; Fariduddin Md; Abbas Orabi; Kaushik Ramaiya; Sameer Al Shammari; Dina Shrestha; Khalid Shaikh; Sachitha Abhayaratna; Pradeep K Shrestha; Aravinthan Mahalingam; Mazen Askheta; Aly Ahmed A Rahim; Fatimah Eliana; Hari K Shrestha; Sandeep Chaudhary; Nancy Ngugi; Jean Claude Mbanya; Than Than Aye; Tint Swe Latt; Zhanay A Akanov; Abbas Raza Syed; Nikhil Tandon; A G Unnikrishnan; S V Madhu; Ali Jawa; Subhankar Chowdhury; Sarita Bajaj; Ashok Kumar Das Journal: Indian J Endocrinol Metab Date: 2018 Jan-Feb