Ying Liang1, Hua Meng2, Ruiyu Li3, Jianbin Yang4, Jingchao Jia2, Yongli Hou5. 1. Department of Cardiology, Changhai Hospital of Naval Military Medical University, Shanghai 200438. 2. Department of Medicine, People's Hospital of Ningxia Hui Autonomous Region, Yinchuan 750002. 3. Department of Chinese Medicine, The Second Affiliated Hospital of Xingtai Medical College, Hebei 054000. 4. Department of Pharmacy, Xingtai People's Hospital, Hebei 054001. 5. Department of Research Office, The Second Affiliated Hospital of Xingtai Medical College, Hebei 054000, China.
Abstract
BACKGROUND: Recently, many clinical experiments have evaluated the influences of liraglutide in the treatment of type 2 diabetes. However, the outcomes of these studies are inconsistent, and the number of high-quality prospective trials that conducted to assess the cardiovascular safety is limited. Hence, for this research, it was implemented for the assessment of the cardiovascular effectiveness and safety of liraglutide in type 2 diabetes patients. METHODS: This research was a 26-week active controlled and randomized trial. Our research protocol follows the guidelines of Good Clinical Practice issued via the Helsinki Declaration and International Conference on Coordination. All the patients will receive the written informed consent in order to involve in our clinical experiment. The participants with type 2 diabetes aged from 18 years to 80 years, patients with 45.0 kg/m2 body-mass index or less, and with glycosylated hemoglobin of 7.5 to 10.0 percent, and receivedmetformin (daily 1500 mg or more) for 3 months or longer were eligible. All the patients were randomized to 1 of 2 interventions (in the ratio of 1:1): liraglutide placebo once daily (blinded) and liraglutide once daily (blinded), respectively, both combined with the glimepiride and metformin (open-labeled). For the efficacy variable, the major endpoint was the baseline glycated hemoglobin change after treating for 26 weeks. The secondary end points involved: the percentage of participants who achieved the goals of postprandial blood glucose, fasting blood glucose, and glycosylated hemoglobin; the changes of mean postprandial blood glucose, fasting blood glucose, and the body weight, pancreatic B-cell function index, and changes in blood pressure and insulin resistance assessed by homeostasis model. CONCLUSIONS: For this research, the limitations involve the short trial period and the limitation of glimepiride in some countries, thus excluding the maximum doses of glimepiride. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry6306).
RCT Entities:
BACKGROUND: Recently, many clinical experiments have evaluated the influences of liraglutide in the treatment of type 2 diabetes. However, the outcomes of these studies are inconsistent, and the number of high-quality prospective trials that conducted to assess the cardiovascular safety is limited. Hence, for this research, it was implemented for the assessment of the cardiovascular effectiveness and safety of liraglutide in type 2 diabetespatients. METHODS: This research was a 26-week active controlled and randomized trial. Our research protocol follows the guidelines of Good Clinical Practice issued via the Helsinki Declaration and International Conference on Coordination. All the patients will receive the written informed consent in order to involve in our clinical experiment. The participants with type 2 diabetes aged from 18 years to 80 years, patients with 45.0 kg/m2 body-mass index or less, and with glycosylated hemoglobin of 7.5 to 10.0 percent, and received metformin (daily 1500 mg or more) for 3 months or longer were eligible. All the patients were randomized to 1 of 2 interventions (in the ratio of 1:1): liraglutide placebo once daily (blinded) and liraglutide once daily (blinded), respectively, both combined with the glimepiride and metformin (open-labeled). For the efficacy variable, the major endpoint was the baseline glycated hemoglobin change after treating for 26 weeks. The secondary end points involved: the percentage of participants who achieved the goals of postprandial blood glucose, fasting blood glucose, and glycosylated hemoglobin; the changes of mean postprandial blood glucose, fasting blood glucose, and the body weight, pancreatic B-cell function index, and changes in blood pressure and insulin resistance assessed by homeostasis model. CONCLUSIONS: For this research, the limitations involve the short trial period and the limitation of glimepiride in some countries, thus excluding the maximum doses of glimepiride. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry6306).
Authors: Richard E Pratley; Michael Nauck; Timothy Bailey; Eduard Montanya; Robert Cuddihy; Sebastiano Filetti; Anne Bloch Thomsen; Rie Elvang Søndergaard; Melanie Davies Journal: Lancet Date: 2010-04-24 Impact factor: 79.321
Authors: Song Ding; Yong-Ping Du; Nan Lin; Yuan-Yuan Su; Fan Yang; Ling-Cong Kong; Heng Ge; Jun Pu; Ben He Journal: Int J Cardiol Date: 2016-07-30 Impact factor: 4.164
Authors: P Gargiulo; G Savarese; C D'Amore; F De Martino; L H Lund; F Marsico; S Dellegrottaglie; C Marciano; B Trimarco; P Perrone-Filardi Journal: Nutr Metab Cardiovasc Dis Date: 2017-09-28 Impact factor: 4.222
Authors: S Calanna; M Christensen; J J Holst; B Laferrère; L L Gluud; T Vilsbøll; F K Knop Journal: Diabetologia Date: 2013-02-03 Impact factor: 10.122
Authors: Michael Nauck; Anders Frid; Kjeld Hermansen; Nalini S Shah; Tsvetalina Tankova; Ismail H Mitha; Milan Zdravkovic; Maria Düring; David R Matthews Journal: Diabetes Care Date: 2008-10-17 Impact factor: 17.152