Skip to content
2000
  1. Home
  2. A-Z Publications
  3. Current Diabetes Reviews
  4. Fast Track Articles
  5. Fast Track Article
image of Effectiveness and Safety of Metformin, Teneligliptin, and Glimepiride Combination Therapy in Type 2 Diabetes: A Quasi Experimental Clinical Trial

Abstract

Introduction

Type 2 Diabetes Mellitus (T2DM) accounts for more than 95% of all diabetes cases and is a leading cause of disability and death. This study aimed to evaluate the effectiveness and safety of a combination therapy involving metformin, teneligliptin, and glimepiride in patients diagnosed with T2DM.

Methods

The present quasi-experimental clinical trial involved 300 adult T2DM patients. They were divided into three groups: Group 1 (Metformin; n=100), Group 2 (Metformin + Teneligliptin; n=100), and Group 3 (Metformin + Teneligliptin +; n=100). Along with demographic data, we collected information on HbA1c, FBS, and PPBS levels, as well as fasting insulin, C-Peptide, HOMA-IR, QUICKI-IR, and lipid, renal, and hepatic profiles at baseline and after 3, 6, and 12 months. Data analysis was performed using SPSS 21.0 software.

Results

A total of 300 patients participated in the study. At the end of 12 months, triple-drug therapy achieved significant glycemic control (HbA1c: 6.56±0.50%; 0.0001) and reduced FBS (7.6±1.41 mg/dl; 0.0001), PPBS (9.39±2.14 mg/dl; 0.0001), and fasting insulin (11.26±2.5 IU; 0.0001), C-peptide (2.01±2.29 ng/ml; 0.0001), and insulin resistance by HOMA-IR (3.74±0.7; 0.0001). Favorable lipid profiles (0.0001) were noted versus other groups. Despite renal and hepatic profile variations, values remained within the normal range.

Conclusion

The combination of teneligliptin with metformin and glimepiride in T2DM patients demonstrated significant improvements in glycaemic control, reduced insulin resistance, and positive effects on lipid, renal, and hepatic profiles. Importantly, the therapy did not result in serious adverse drug reactions, such as hypoglycemia. We need more RCTs to substantiate these findings.

© 2024 Bentham Science Publishers
Loading

Article metrics loading...

/content/journals/cdr/10.2174/0115733998292943240730115310
2024-11-29
2025-01-22

  • From This Site

    /content/journals/cdr/10.2174/0115733998292943240730115310
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

References

  1. Hossain M.J. Al-Mamun M. Islam M.R. Diabetes mellitus, the fastest growing global public health concern: Early detection should be focused. Health Sci. Rep. 2024 7 3 e2004 10.1002/hsr2.2004 38524769
    [Google Scholar]
  2. Kahn C.R. Banting Lecture. Insulin action, diabetogenes, and the cause of type II diabetes. Diabetes 1994 43 8 1066 1085 10.2337/diab.43.8.1066 8039601
    [Google Scholar]
  3. Chenchula S. Gupta R. S B. Vishwe A. Gour P. Kumar S. An observational cross-sectional study to determine the effect of telmisartan on reducing microalbuminuria in diabetic hypertensive patients in tertiary care teaching hospital, Central India. Int. J. Basic Clin. Pharmacol. 2017 6 8 2082 2086 10.18203/2319‑2003.ijbcp20173300
    [Google Scholar]
  4. Elder D.A. Hornung L.N. Herbers P.M. Prigeon R. Woo J.G. D’Alessio D.A. Rapid deterioration of insulin secretion in obese adolescents preceding the onset of type 2 diabetes. J. Pediatr. 2015 166 3 672 678 10.1016/j.jpeds.2014.11.029 25557969
    [Google Scholar]
  5. Fu Z. Gilbert E.R. Liu D. Regulation of insulin synthesis and secretion and pancreatic Beta-cell dysfunction in diabetes. Curr. Diabetes Rev. 2013 9 1 25 53 10.2174/157339913804143225 22974359
    [Google Scholar]
  6. Pinhas-Hamiel O. Zeitler P. Type 2 Diabetes in Children and Adolescents- A Focus on Diagnosis and Treatment. South Dartmouth (MA), MDText.com, Inc. 2000
    [Google Scholar]
  7. Zhu R. Zhou S. Xia L. Bao X. Incidence, Morbidity and years Lived With Disability due to Type 2 Diabetes Mellitus in 204 Countries and Territories: Trends From 1990 to 2019. Front. Endocrinol. (Lausanne) 2022 13 905538 10.3389/fendo.2022.905538 35898461
    [Google Scholar]
  8. Mohan V. Pradeepa R. Epidemiology of type 2 diabetes in India. Indian J. Ophthalmol. 2021 69 11 2932 2938 10.4103/ijo.IJO_1627_21 34708726
    [Google Scholar]
  9. Piché ME. Tchernof A. Després JP. Obesity phenotypes, diabetes, and cardiovascular diseases. Circ Res. 2020 126 11 1477 1500 10.1161/CIRCRESAHA.120.316101
    [Google Scholar]
  10. Children and Adolescents: Standards of Medical Care in Diabetes−2020. Diabetes Care 2020 43 Suppl. 1 S163 S182 10.2337/dc20‑S013 31862756
    [Google Scholar]
  11. American Diabetes Association Professional Practice Committee 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2022. Diabetes Care 2022 45 Suppl. 1 S125 S143 10.2337/dc22‑S009 34964831
    [Google Scholar]
  12. Davies M.J. D’Alessio D.A. Fradkin J. Kernan W.N. Mathieu C. Mingrone G. Rossing P. Tsapas A. Wexler D.J. Buse J.B. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2018 41 12 2669 2701 10.2337/dci18‑0033 30291106
    [Google Scholar]
  13. Type 2 diabetes in adults:management NICE guidelines 2015
    [Google Scholar]
  14. Kanatsuka A. Sato Y. Kawai K. Hirao K. Kobayashi M. Kashiwagi A. Abe N. Arai K. Fujiya H. Fukumoto Y. Dake F. Iizumi T. Ito M. Iwasaki K. Kanamori A. Kato S. Kato M. Kawara A. Kimura K. Chikamori K. Iemitsu K. Kou S. Kudo M. Kurihara Y. Lee G. Tsuruoka A. Manda N. Matoba K. Hayashi H. Minami M. Kuribayashi N. Miyazawa K. Chiba Y. Osonoi T. Nakamura S. Sasaki H. Komori K. Oishi M. Okada A. Okuguchi F. Yanagisawa M. Sugimoto H. Sugiyama H. Takai M. Takaki M. Takamura H. Takeda H. Takeda H. Tanaka K. Miwa T. Tomonaga O. Taguchi M. Yamazaki K. Wada T. Yagi N. Yamaoka K. Yuhara A. Japan Diabetes Clinical Data Management Study Group (JDDM) Relationship between the efficacy of oral antidiabetic drugs and clinical features in type 2 diabetic patients (JDDM38). J. Diabetes Investig. 2016 7 3 386 395 10.1111/jdi.12430 27330726
    [Google Scholar]
  15. Chenchula S. Varthya S.B. Padmavathi R. Rationality, Efficacy, Tolerability of Empagliflozin Plus Linagliptin Combination for the Management of Type 2 Diabetes Mellitus: A Systematic Review of Randomized Controlled Trials and Observational Studies. Curr. Diabetes Rev. 2022 18 4 e100921196392 10.2174/1573399817666210910165402 34514991
    [Google Scholar]
  16. Gottschalk M. Danne T. Vlajnic A. Cara J.F. Glimepiride versus metformin as monotherapy in pediatric patients with type 2 diabetes: a randomized, single-blind comparative study. Diabetes Care 2007 30 4 790 794 10.2337/dc06‑1554 17392540
    [Google Scholar]
  17. Hemmingsen B. Schroll J.B. Wetterslev J. Gluud C. Vaag A. Sonne D.P. Lundstrøm L.H. Almdal T. Sulfonylurea versus metformin monotherapy in patients with type 2 diabetes: a Cochrane systematic review and meta-analysis of randomized clinical trials and trial sequential analysis. CMAJ Open 2014 2 3 E162 E175 10.9778/cmajo.20130073 25295236
    [Google Scholar]
  18. Qian D. Zhang T. Zheng P. Liang Z. Wang S. Xie J. Zhao L. Zhang Y. Situ B. Comparison of Oral Antidiabetic Drugs as Add-On Treatments in Patients with Type 2 Diabetes Uncontrolled on Metformin: A Network Meta-Analysis. Diabetes Ther. 2018 9 5 1945 1958 10.1007/s13300‑018‑0482‑5 30121726
    [Google Scholar]
  19. Eto T. Inoue S. Kadowaki T. Effects of once‐daily teneligliptin on 24‐h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4‐week, randomized, double‐blind, placebo‐controlled trial. Diabetes Obes. Metab. 2012 14 11 1040 1046 10.1111/j.1463‑1326.2012.01662.x 22776014
    [Google Scholar]
  20. Siriesha Sharma N. Lugani Y. Kaur A. Ahuja V. Effect of metformin on insulin levels, blood sugar, and body mass index in polycystic ovarian syndrome cases. J. Family Med. Prim. Care 2019 8 8 2691 2695 10.4103/jfmpc.jfmpc_490_19 31548957
    [Google Scholar]
  21. Zafar S. Role of metformin in correcting hyperinsulinemia, menstrual irregularity and anovulation in polycystic ovary syndrome. J. Ayub Med. Coll. Abbottabad 2005 17 4 54 56 16599037
    [Google Scholar]
  22. Leighton E. Sainsbury C.A.R. Jones G.C. A Practical Review of C-Peptide Testing in Diabetes. Diabetes Ther. 2017 8 3 475 487 10.1007/s13300‑017‑0265‑4 28484968
    [Google Scholar]
  23. Khan H.A. Sobki S.H. Ekhzaimy A. Khan I. Almusawi M.A. Biomarker potential of C-peptide for screening of insulin resistance in diabetic and non-diabetic individuals. Saudi J. Biol. Sci. 2018 25 8 1729 1732 10.1016/j.sjbs.2018.05.027 30591792
    [Google Scholar]
  24. Kim S.T. Kim B.J. Lim D.M. Song I.G. Jung J.H. Lee K.W. Park K.Y. Cho Y.Z. Lee D.H. Koh G.P. Basal C-peptide Level as a Surrogate Marker of Subclinical Atherosclerosis in Type 2 Diabetic Patients. Diabetes Metab. J. 2011 35 1 41 49 10.4093/dmj.2011.35.1.41 21537412
    [Google Scholar]
  25. Chen C.H. Tsai S.T. Chou P. Correlation of fasting serum C-peptide and insulin with markers of metabolic syndrome-X in a homogeneous Chinese population with normal glucose tolerance. Int. J. Cardiol. 1999 68 2 179 186 10.1016/S0167‑5273(98)00366‑0 10189006
    [Google Scholar]
  26. Xiang A.H. Peters R.K. Kjos S.L. Marroquin A. Goico J. Ochoa C. Kawakubo M. Buchanan T.A. Effect of pioglitazone on pancreatic beta-cell function and diabetes risk in Hispanic women with prior gestational diabetes. Diabetes 2006 55 2 517 522 10.2337/diabetes.55.02.06.db05‑1066 16443789
    [Google Scholar]
  27. Rasouli N. Kern P.A. Reece E.A. Elbein S.C. Effects of pioglitazone and metformin on β-cell function in nondiabetic subjects at high risk for type 2 diabetes. Am. J. Physiol. Endocrinol. Metab. 2007 292 1 E359 E365 10.1152/ajpendo.00221.2006 16968813
    [Google Scholar]
  28. Bunck M.C. Cornér A. Eliasson B. Heine R.J. Shaginian R.M. Taskinen M.R. Smith U. Yki-Järvinen H. Diamant M. Effects of exenatide on measures of β-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care 2011 34 9 2041 2047 10.2337/dc11‑0291 21868779
    [Google Scholar]
  29. Ji L. Li L. Ma J. Li X. Li D. Meng B. Lu W. Sun J. Liu Y. Takayanagi G. Wang Y. Efficacy and safety of teneligliptin added to metformin in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, randomized, double‐blind, placebo‐controlled study. Endocrinol. Diabetes Metab. 2021 4 2 e00222 10.1002/edm2.222 33855222
    [Google Scholar]
  30. Gillani S. Ghayedi N. Roosta P. Seddigh P. Nasiri O. Effect of Metformin on Lipid Profiles of Type 2 Diabetes Mellitus: A Metaanalysis of Randomized Controlled Trials. J. Pharm. Bioallied Sci. 2021 13 1 76 82 10.4103/jpbs.JPBS_370_20 34084051
    [Google Scholar]
  31. United States Renal Data System Incidence, Prevalence,Patient Characteristics, and Treatment Modalities. United States Renal Data System. 2018 USRDS Annual Data Report: Epidemiology of Kidney Disease in the United States. USRDS 2018. pp. 291-331.
    [Google Scholar]
  32. Ghanta M.K. Nayaka S.R. Nuthalapati P. Afzal Khan A.K. Elango P. Lakkakula B.V.K.S. Molecular docking study of Momordica charantia Linn phytoconstituent with caspase 3 and implications for renoprotective actions in diabetes mellitus. J. Nephropharmacol. 2021 11 e10394 10.34172/npj.2022.10394
    [Google Scholar]
  33. Chenchula S. Vidyasagar K. Pathan S. Sharma S. Chavan M.R. Bhagavathula A.S. Padmavathi R. Manjula M. Chhabra M. Gupta R. Amerneni K.C. Ghanta M.K. Mudda S. Global prevalence and effect of comorbidities and smoking status on severity and mortality of COVID-19 in association with age and gender: a systematic review, meta-analysis and meta-regression. Sci. Rep. 2023 13 1 6415 10.1038/s41598‑023‑33314‑9 37076543
    [Google Scholar]
  34. Otsuki H. Kosaka T. Nakamura K. Shimomura F. Kuwahara Y. Tsukamoto T. Safety and efficacy of teneligliptin: a novel DPP-4 inhibitor for hemodialysis patients with type 2 diabetes. Int. Urol. Nephrol. 2014 46 2 427 432 10.1007/s11255‑013‑0552‑6 24014134
    [Google Scholar]
  35. Halabi A. Maatouk H. Siegler K.E. Faisst N. Lufft V. Klause N. Pharmacokinetics of Teneligliptin in Subjects With Renal Impairment. Clin. Pharmacol. Drug Dev. 2013 2 3 246 254 10.1002/cpdd.29 27121786
    [Google Scholar]
  36. Haneda M. Kadowaki T. Ito H. Sasaki K. Hiraide S. Ishii M. Matsukawa M. Ueno M. Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance. Diabetes Ther. 2018 9 3 1083 1097 10.1007/s13300‑018‑0416‑2 29637459
    [Google Scholar]
  37. Ideta T. Shirakami Y. Miyazaki T. Kochi T. Sakai H. Moriwaki H. Shimizu M. The Dipeptidyl Peptidase-4 Inhibitor Teneligliptin Attenuates Hepatic Lipogenesis via AMPK Activation in Non-Alcoholic Fatty Liver Disease Model Mice. Int. J. Mol. Sci. 2015 16 12 29207 29218 10.3390/ijms161226156 26670228
    [Google Scholar]
  38. Ghanta M.K. Khan A.K.A. Bhaskar L.V.K.S. Diagnostic and Prognostic Implications of Cardiac Markers for Hepatocellular Carcinoma. Crit. Rev. Oncog. 2021 26 1 1 10 10.1615/CritRevOncog.2020036305 33641280
    [Google Scholar]
  39. Holstein A. Hinze S. THIEßEn E. Plaschke A. Egberts E-H. Clinical implications of hepatogenous diabetes in liver cirrhosis. J. Gastroenterol. Hepatol. 2002 17 6 677 681 10.1046/j.1440‑1746.2002.02755.x 12100613
    [Google Scholar]
  40. Müller G. Satoh Y. Geisen K. Extrapancreatic effects of sulfonylureas — a comparison between glimepiride and conventional sulfonylureas. Diabetes Res. Clin. Pract. 1995 28 Suppl. S115 S137 10.1016/0168‑8227(95)01089‑V 8529504
    [Google Scholar]
  41. Kim HS. Kim DM. Cha BS. Park TS. Kim KA. Kim DL. Chung CH. Park JH. Jang HC. Choi DS. Efficacy of glimepiride/metformin fixed-dose combination vs metformin uptitration in type 2 diabetic patients inadequately controlled on low-dose metformin monotherapy: A randomized, open label, parallel group, multicenter study in Korea. J Diabetes Investig. 2014 5 6 701 708
    [Google Scholar]
  42. Charpentier G. Fleury F. Kabir M. Vaur L. Halimi S. Improved glycaemic control by addition of glimepiride to metformin monotherapy in Type 2 diabetic patients. Diabet. Med. 2001 18 10 828 834 10.1046/j.1464‑5491.2001.00582.x 11678974
    [Google Scholar]
  43. Foroutan N. Muratov S. Levine M. Safety and efficacy of dipeptidyl peptidase-4 inhibitors vs sulfonylurea in metformin-based combination therapy for type 2 diabetes mellitus: Systematic review and meta-analysis. Clin. Invest. Med. 2016 39 2 48 10.25011/cim.v39i2.26481 27040861
    [Google Scholar]
  44. Farah D. Leme G.M. Eliaschewitz F.G. Fonseca M.C.M. A safety and tolerability profile comparison between dipeptidyl peptidase-4 inhibitors and sulfonylureas in diabetic patients: A systematic review and meta-analysis. Diabetes Res. Clin. Pract. 2019 149 47 63 10.1016/j.diabres.2019.01.025 30710655
    [Google Scholar]
  45. Zhang Y. Hong J. Chi J. Gu W. Ning G. Wang W. Head‐to‐head comparison of dipeptidyl peptidase‐IV inhibitors and sulfonylureas – a meta‐analysis from randomized clinical trials. Diabetes Metab. Res. Rev. 2014 30 3 241 256 10.1002/dmrr.2482 24123720
    [Google Scholar]
  46. Ou S.M. Shih C.J. Chao P.W. Chu H. Kuo S.C. Lee Y.J. Wang S.J. Yang C.Y. Lin C.C. Chen T.J. Tarng D.C. Li S.Y. Chen Y.T. Effects on Clinical Outcomes of Adding Dipeptidyl Peptidase-4 Inhibitors Versus Sulfonylureas to Metformin Therapy in Patients With Type 2 Diabetes Mellitus. Ann. Intern. Med. 2015 163 9 663 672 10.7326/M15‑0308 26457538
    [Google Scholar]
  47. Kim M.K. Rhee E.J. Han K.A. Woo A.C. Lee M.K. Ku B.J. Chung C.H. Kim K.A. Lee H.W. Park I.B. Park J.Y. Chul Jang H.C. Park K.S. Jang W.I. Cha B.Y. Efficacy and safety of teneligliptin, a dipeptidyl peptidase‐4 inhibitor, combined with metformin in K orean patients with type 2 diabetes mellitus: a 16‐week, randomized, double‐blind, placebo‐controlled phase III trial. Diabetes Obes. Metab. 2015 17 3 309 312 10.1111/dom.12424 25475929
    [Google Scholar]
  48. Nishanth T. Maheshwari C.U. Lakshmi R.S. Sri D. Goud P. Tabassum K. A study to compare efficacy of metformin, glimepiride versus metformin-teneligliptin in Type ii diabetic patients. Int. J. Pharm. Sci. Res. 2018 9 5258 5264
    [Google Scholar]
  49. González-Ortiz M. Guerrero-Romero J.F. Violante-Ortiz R. Wacher-Rodarte N. Martínez-Abundis E. Aguilar-Salinas C. Islas-Andrade S. Arechavaleta-Granell R. González-Canudas J. Rodríguez-Morán M. Zavala-Suárez E. Ramos-Zavala M.G. Metha R. Revilla-Monsalve C. Beltrán-Jaramillo T.J. Efficacy of glimepiride/metformin combination versus glibenclamide/metformin in patients with uncontrolled type 2 diabetes mellitus. J. Diabetes Complications 2009 23 6 376 379 10.1016/j.jdiacomp.2008.09.002 18849173
    [Google Scholar]
  50. Hans N. The Efficacy and Safety of Teneligliptin and Metformin versus Glimepiride and Metformin in Patients of Type-2 Diabetes Mellitus Uncontrolled with Monotherapy. J. Diabetes Metab. 2019 10 829
    [Google Scholar]
  51. Bryson A. Jennings P.E. Deak L. Paveliu F.S. Lawson M. The efficacy and safety of teneligliptin added to ongoing metformin monotherapy in patients with type 2 diabetes: a randomized study with open label extension. Expert Opin. Pharmacother. 2016 17 10 1309 1316 10.1080/14656566.2016.1190334 27181910
    [Google Scholar]
  52. Chenchula S. Sharma S. Tripathi M. Chavan M. Misra A.K. Rangari G. Prevalence of overweight and obesity and their effect on COVID‐19 severity and hospitalization among younger than 50 years versus older than 50 years population: A systematic review and meta‐analysis. Obes. Rev. 2023 24 11 e13616 10.1111/obr.13616 37574901
    [Google Scholar]
/content/journals/cdr/10.2174/0115733998292943240730115310
Loading
Effectiveness and Safety of Metformin, Teneligliptin, and Glimepiride Combination Therapy in Type 2 Diabetes: A Quasi Experimental Clinical Trial
Bentham Science Publishers ; https://doi.org/10.2174/0115733998292943240730115310
/content/journals/cdr/10.2174/0115733998292943240730115310
/content/journals/cdr/10.2174/0115733998292943240730115310
Loading

Data & Media loading...


  • Article Type:     Research Article
Keywords: Type-2 diabetes mellitus ; efficacy and safety ; teneligliptin ; metformin ; glimepiride ; triple drug therapy

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test