Combined effect of metformin with ascorbic acid versus acetyl salicylic acid on diabetes-related cardiovascular complication; a 12-month single blind multicenter randomized control trial

Cardiovascular Diabetology

Original Investigation

Mohi Iqbal Mohammad Abdul¹  Syed Wasif Gillani²  Mirza R. Baig³  Syed Azhar Syed Sulaiman⁴ 

[1] College of Pharmacy, Taibah University, Medina, Al-Madinah Munawarah, Saudi Arabia;College of Pharmacy, University of Philippines, Quezon, Philippines;College of Pharmacy, Taibah University, Medina, Al-Madinah Munawarah, Saudi Arabia;Pharmacotherapy Research Group, Islamabad, Pakistan;Pharmacotherapy Research Group, Kuala Lumpur, Malaysia;Dubai College of Pharmacy, Dubai, UAE;School of Pharmaceutical Sciences, Universiti Sains Malaysia (USM), George Town, Malaysia;

关键词: Metformin;    Diabetes care;    Antioxidants;    Anti-inflammatory;    Randomized control trials;   

DOI  :  10.1186/s12933-017-0584-9

 received in 2017-06-08, accepted in 2017-07-31,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundWe aimed to investigate the efficacy of ascorbic acid and acetylsalicylic acid among type II diabetes mellitus patients using metformin (only) for diabetes management therapy.MethodA 12-month single blinded multicenter randomized control trial was designed to investigate the measured variables [Glycated Hemoglobin (HbA1c), Renal function, Albumin Creatinine Ratio (ACR) etc.]. The trial was randomized into 2 experimental parallel arms (ascorbic acid vs acetylsalicylic acid) were blinded with study supplements in combination with metformin and findings were compared to control arm with metformin alone and blinded with placebo. Withdrawal criteria was defined to maintain the equity and balance in the participants in the whole trial.FindingPatients with metformin and ascorbic acid (parallel arm I) was twice more likely to reduce HbA1c than metformin alone (control arm) in a year (OR 2.31 (95% CI 1.87–4.42) p < 0.001). Also Parallel arm I was ten times more likely to reduced risk factors contributing to long-term diabetes complications than participants of arm II in a year (OR 10.38 (95% CI 6.91–15.77) p < 0.001). In contrast, parallel arm II patients were seven times more effective to reduce the risk of expected CVD development in 10 years than arm I (OR 7.54 (95% CI 3.76–10.32) p < 0.001).ConclusionsThe trial concluded that ascorbic acid with metformin is more effective against reducing risks for diabetes related long-term complications (including ACR).TRIAL details Registration No: NTR-6100, Registry Name: Netherlands Trial Registry, URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6100, Date of Registration: 20th October, 2016, Date of first Enrollment: 1 November, 2015.

【 授权许可】

CC BY   
© The Author(s) 2017