Author(s):
Irfan Ahmad Khan, Shalini Chandra, Mohan Lal Kanojia
Email(s):
ahmadpharma5@gmail.com
DOI:
10.52711/0974-360X.2023.00586
Address:
Irfan Ahmad Khan1*, Shalini Chandra2, Mohan Lal Kanojia3
1PhD Scholar, BIU, Assistant Professor Department of Pharmacology, Mayo Institute of Medical Sciences, Barabanki, Lucknow - 225001, Uttar Pradesh, India.
2Professor and Head, Department of Pharmacology, Rohilkhand Medical College and Hospital, Bareilly - 243006, Uttar Pradesh, India.
3Professor, Department of General Medicine, Mayo Institute of Medical Sciences, Barabanki, Lucknow - 225001, Uttar Pradesh, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 8,
Year - 2023
ABSTRACT:
A low level of vitamin D is being attributed to the development of diabetes, which can cause insulin resistance, beta-cell death, and inflammation. Vitamin D supplementation can reduce inflammation and insulin resistance. we conducted this study for our population to evaluate the effect of vitamin D on blood glucose in type 2 diabetes mellitus. A prospective interventional, parallel, randomized study, was conducted on 112 type two diabetes and 25(OH) D deficient patients. The control group received Metformin (500mg BD) and Teneligliptin (20mg OD) only, while the intervention group was given Metformin plus Teneligliptin along with vitamin D (Cholecalciferol) (60,000 IU). At the end of 3rd of month follow-up, there was a significant difference in mean FPG and PPG (129.86±7.36mg/dl) vs. (136.12±11.31mg/dl) (p=0.002), (220.81±13.04mg/dl) vs. (228.06±19.40 mg/dl) (p=0.037). in the interventional and control group respectively. And subsequently, mean HbA1c improved significantly in the interventional group as compared to the control group 7.21±0.40% vs. 7.48.0.62% respectively (p = 0.015). also, the measures of glycemic control (FPG, PPG, HbA1c) showed a significant improvement at the end of the 6 months. Our study suggested, that add-on therapy of Vitamin D improved the glycemic parameters of type two diabetes mellitus with concurrent vitamin D deficiency over the course of the study.
Cite this article:
Irfan Ahmad Khan, Shalini Chandra, Mohan Lal Kanojia. Vitamin D as add on Therapy to Metformin and Teneligliptin in patients with type 2 Diabetes Mellitus. Research Journal of Pharmacy and Technology 2023; 16(8):3549-3. doi: 10.52711/0974-360X.2023.00586
Cite(Electronic):
Irfan Ahmad Khan, Shalini Chandra, Mohan Lal Kanojia. Vitamin D as add on Therapy to Metformin and Teneligliptin in patients with type 2 Diabetes Mellitus. Research Journal of Pharmacy and Technology 2023; 16(8):3549-3. doi: 10.52711/0974-360X.2023.00586 Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-8-6
REFERENCES:
1. GBD 2019 Risk Factors Collaborators. Global burden of 87 risk factors in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020; 396(10258): 1223–49. http://dx.doi.org/10.1016/S0140-6736(20)30752-2
2. Geetha V, Sahu SK, Susila C. Assess quality of life (QOL) and glycemic level among type 2 diabetic patients in global hospital and research centre and its units, sirohi, Rajasthan. Asian J Nurs Educ Res. 2017;7(4): 577.http://dx.doi.org/10.5958/2349-2996.2017.00112.4
3. Kumar DRA, Assistant Professor, Karnataka Institute of Endocrinology and Research Bangalore, Karnataka, India. A comparative study to determine vitamin D status in type 2 diabetes and normal subjects in south India. Int J Med Res Rev. 2017;5(10):888–93. http://dx.doi.org/10.17511/ijmrr.2017.i10.03
4. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014;37 Suppl 1(Supplement_1): S81-90.http://dx.doi.org/10.2337/dc14-S081
5. Goyal R, Jialal I. Diabetes Mellitus Type 2. Stat Pearls Treasure Island (FL). 2021;
6. Suraj B, Tripathi CD, Biswas K, Padhy BM, Arora T. A comparative evaluation of safety, efficacy and cost-effectiveness of three add-on treatment regimens in type 2 diabetics; Not controlled by metformin alone. Res J Pharm Technol. 2015;8(1):44.http://dx.doi.org/10.5958/0974-360x.2015.00009.8
7. Stegbauer C, Falivena C, Moreno A, Hentschel A, Rosenmöller M, Heise T, et al. Costs and its drivers for diabetes mellitus type 2 patients in France and Germany: a systematic review of economic studies. BMC Health Serv Res. 2020;20(1):1043.http://dx.doi.org/10.1186/s12913-020-05897-w
8. Subashree R, Arjunkumar R. Vitamin D Deficiency in Periodontal Health. Research J Pharm and Tech. 2014;7(2):248–52.
9. Shwetha MN, Priya PNC. Knowledge regarding vitamin D deficiency among students. Asian J Nurs Educ Res. 2019;9(1):66. http://dx.doi.org/10.5958/2349-2996.2019.00013.2
10. Berridge MJ. Vitamin D deficiency and diabetes. Biochem J2017;474(8):1321–32. http://dx.doi.org/10.1042/BCJ20170042
11. Mattila C, Knekt P, Männistö S, Rissanen H, Laaksonen MA, Montonen J, et al. Serum 25-hydroxyvitamin D concentration and subsequent risk of type 2 diabetes. Diabetes Care 2007;30(10):2569–70. http://dx.doi.org/10.2337/dc07-0292
12. Gupta S, Aparna P, Muthathal S, Nongkynrih B. Vitamin D deficiency in India. J Family Med Prim Care 2018;7(2): 324.http://dx.doi.org/10.4103/jfmpc.jfmpc_78_18
13. Subramanian A, Nigam P, Misra A, Pandey RM, Mathur M, Gupta R, et al. Severe vitamin D deficiency in patients with Type 2 diabetes in north India. Diabetes Manag (Lond) 2011;1(5):477–83. http://dx.doi.org/10.2217/dmt.11.38
14. Ozfirat Z, Chowdhury TA. Vitamin D deficiency and type 2 diabetes. Postgrad Med J 2010;86(1011):18–25; quiz 24. http://dx.doi.org/10.1136/pgmj.2009.078626
15. Borissova AM, Tankova T, Kirilov G, Dakovska L, Kovacheva R. The effect of vitamin D3 on insulin secretion and peripheral insulin sensitivity in type 2 diabetic patients. Int J Clin Pract. 2003;57(4):258–61.
16. Chiu KC, Chu A, Go VLW, Saad MF. Hypovitaminosis D is associated with insulin resistance and beta cell dysfunction. Am J Clin Nutr. 2004; 79(5): 820–5. http://dx.doi.org/10.1093/ajcn/79.5.820
17. Bichala PK, Kumar KJ, Suthakaran R, Shankar C. Development and validation of an analytical method for the estimation of metformin and teneligliptin in its bulk and tablet dosage form by using RP-HPLC. Asian J Pharm Anal. 2020;10(1):11. http://dx.doi.org/10.5958/2231-5675.2020.00003.4
18. Maheshwari P, Shanmugarajan TS. Evaluation of prescribing practices of metformin in patients with type-2 diabetes mellitus. Res J Pharm Technol. 2019; 12(2): 531. http://dx.doi.org/10.5958/0974-360x.2019.00093.3
19. Daharwal SJ, Rao SP, Singh VK, Dwivedi C, Singh VD. Comparative evaluation of marketed formulations of Metformin HCl. available in India. Asian J Res Chem. 2015;8(7): 441.http://dx.doi.org/10.5958/0974-4150.2015.00070.x
20. Soumya K, Susanna S, Murthy TEGK. In vitro dissolution studies on commercial brands containing immediate release pioglitazone and metformin hydrochloride extended-release tablets. Res J Pharm Dos Forms Technol. 2017; 9(1): 15. http://dx.doi.org/10.5958/0975-4377.2017.00003.9
21. Annapurna MM, Naik RR, Pratyusha SM. Simultaneous spectrophotometric determination of compounds: Application to an anti-diabetic formulation of Teneligliptin and Metformin. Res J Pharm Technol. 2020;13(4): 1938.http://dx.doi.org/10.5958/0974-360x.2020.00349.2
22. Kajbaf F, Mentaverri R, Diouf M, Fournier A, Kamel S, Lalau J-D. The association between 25-hydroxyvitamin D and hemoglobin A1c levels in patients with type 2 diabetes and stage 1-5 chronic kidney disease. Int J Endocrinol. 2014; 2014:142468.http://dx.doi.org/10.1155/2014/142468
23. Randhawa FA, Mustafa S, Khan DM, Hamid S. Effect of Vitamin D supplementation on reduction in levels of HbA1 in patients recently diagnosed with type 2 Diabetes Mellitus having asymptomatic Vitamin D deficiency. Pak J Med Sci Q. 2017;33(4):881–5. http://dx.doi.org/10.12669/pjms.334.12288
24. Orwoll E, Riddle M, Prince M. Effects of vitamin D on insulin and glucagon secretion in non-insulin-dependent diabetes mellitus. Am J Clin Nutr. 1994; 59(5): 1083–7. http://dx.doi.org/10.1093/ajcn/59.5.1083
25. Sheth JJ, Shah A, Sheth FJ, Trivedi S, Lele M, Shah N, et al. Does vitamin D play a significant role in type 2 diabetes? BMC Endocr Disord. 2015;15(1). http://dx.doi.org/10.1186/s12902-015-0003-8
26. Nwosu BU, Maranda L. The effects of vitamin D supplementation on hepatic dysfunction, vitamin D status, and glycemic control in children and adolescents with vitamin D deficiency and either type 1 or type 2 diabetes mellitus. PLoS One. 2014;9(6): e99646. http://dx.doi.org/10.1371/journal.pone.0099646
27. Sofihussein HQ, Al-Naqshabandi AA, Sami HF, Saeed MMM. Effect of vitamin d supplement on the risks of cardiovascular disease in patients with type 2 diabetes in the Kurdistan region of Iraq. Res J Pharm Technol. 2020; 13(9): 4125. http://dx.doi.org/10.5958/0974-360x.2020.00728.3
28. Madar AA, Knutsen KV, Stene LC, Brekke M, Meyer HE, Lagerløv P. Effect of vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, serum lipids, and body mass index: a randomized, double-blinded, placebo-controlled trial among healthy immigrants living in Norway. BMJ Open Diabetes Res Care. 2014;2(1):e000026. http://dx.doi.org/10.1136/bmjdrc-2014-000026
29. Talaei A, Mohamadi M, Adgi Z. The effect of vitamin D on insulin resistance in patients with type 2 diabetes. Diabetol Metab Syndr. 2013;5(1):8. http://dx.doi.org/10.1186/1758-5996-5-8
30. Upreti V, Maitri V, Dhull P, Handa A, Prakash MS, Behl A. Effect of oral vitamin D supplementation on glycemic control in patients with type 2 diabetes mellitus with coexisting hypovitaminosis D: A parallel-group placebo-controlled randomized controlled pilot study. Diabetes Metab Syndr. 2018; 12(4): 509–12. http://dx.doi.org/10.1016/j.dsx.2018.03.008
31. Banzal N, Desai A. The impact of vitamin D3 supplementation on glycemic control in type-2 diabetes mellitus at a tertiary care hospital. Int J Basic Clin Pharmacol. 2020;9(9): 1417.http://dx.doi.org/10.18203/2319-2003.ijbcp20203629
32. Johnson JA, Grande JP, Roche PC, Kumar R. Immunohistochemical localization of the 1,25(OH)2D3 receptor and calbindin D28k in human and rat pancreas. Am J Physiol. 1994; 267(3 Pt 1): E356-60. http://dx.doi.org/10.1152/ajpendo.1994.267.3.E356
33. Zeitz U, Weber K, Soegiarto DW, Wolf E, Balling R, Erben RG. Impaired insulin secretory capacity in mice lacking a functional vitamin D receptor. FASEB J. 2003;17(3):509–11. http://dx.doi.org/10.1096/fj.02-0424fje
34. Szymczak-Pajor I, Drzewoski J, Śliwińska A. The molecular mechanisms by which vitamin D prevents insulin resistance and associated disorders. Int J Mol Sci. 2020;21(18):6644. http://dx.doi.org/10.3390/ijms21186644
35. Fujita T, Palmieri GM. Calcium paradox disease: calcium deficiency prompting secondary hyperparathyroidism and cellular calcium overload. J Bone Miner Metab. 2000;18(3):109–25. http://dx.doi.org/10.1007/s007740050101