Login Register Cart 0
Generic placeholder image

Current Diabetes Reviews

Editor-in-Chief

ISSN (Print): 1573-3998
ISSN (Online): 1875-6417

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Review Article

Clinical Evidence and Practice-Based Guidelines on the Utility of Basal Insulin Combined Oral Therapy (Metformin and Glimepiride) in the Current Era

Author(s): Abhishek Shrivastava*, Jothydev Kesavadev, Viswanathan Mohan, Banshi Saboo, Dina Shrestha, Anuj Maheshwari, Brij Mohan Makkar, Kirtikumar D. Modi and Ashok Kumar Das

Volume 19, Issue 8, 2023

Published on: 15 February, 2023

Article ID: e090123212444 Pages: 8

DOI: 10.2174/1573399819666230109104300

Price: $65

Abstract

Background and Aim: Basal insulin combined oral therapy consisting of insulin and oral anti-diabetic drugs (OADs) is recommended for type 2 diabetes uncontrolled on OADs. There is a lack of clear evidence and recommendations on the combined use of basal insulin analogues to more than one OADs (glimepiride plus metformin) in effective control of glycemic parameters and its safety in terms of reduced hypoglycemic events, weight gain and cardiovascular risk. In this context, a group of clinical experts discussed the utility of basal insulin combined oral therapy with metformin and glimepiride in the current era.

Methods: The clinical experts discussed and provided their inputs virtually. The expert panel included clinical experts comprising endocrinologists and diabetologists from India and Nepal.

Results: The panel thoroughly reviewed existing literature on the subject and proposed clinical evidence and practice-based guidelines.

Conclusion: These current clinical practice guidelines highlight the efficacy and safety of basal insulin combination therapy with various available basal insulins including neutral protamine hagedorn, detemir, glargine and degludec in addition to metformin and glimepiride therapy.

[1]
Khursheed R, Singh SK, Wadhwa S, et al. Treatment strategies against diabetes: Success so far and challenges ahead. Eur J Pharmacol 2019; 862: 172625.
[http://dx.doi.org/10.1016/j.ejphar.2019.172625] [PMID: 31449807]
[2]
Das AK, Mithal A, Joshi S, et al. Baseline characteristics of participants in the LANDMARC trial: A 3‐year, pan ‐India, prospective, longitudinal study to assess management and real‐world outcomes of diabetes mellitus. Endocrinol Diabetes Metab 2021; 4(3): e00231.
[http://dx.doi.org/10.1002/edm2.231] [PMID: 34277959]
[3]
Suzuki D, Umezono T, Miyauchi M, et al. Effectiveness of Basal-Supported Oral Therapy (BOT) using insulin glargine in patients with poorly controlled type 2 diabetes. Tokai J Exp Clin Med 2012; 37(2): 41-6.
[PMID: 22763826]
[4]
Danne T, Bluhmki T, Seufert J, et al. Treatment intensification using long-acting insulin -predictors of future basal insulin supported oral therapy in the DIVE registry. BMC Endocr Disord 2015; 15(1): 54.
[http://dx.doi.org/10.1186/s12902-015-0051-0] [PMID: 26446863]
[5]
Sorli C, Heile MK. Identifying and meeting the challenges of insulin therapy in type 2 diabetes. J Multidiscip Healthc 2014; 7: 267-82.
[http://dx.doi.org/10.2147/JMDH.S64084] [PMID: 25061317]
[6]
Abbassy A, Saad A, Oraby A. Effectiveness and safety of insulin glargine plus glimepiride after 6 months of treatment among patients with type 2 diabetes mellitus who failed premixed insulin: An observational study conducted in Egypt. Egyptian J Obesity, Diabetes Endocrinol 2017; 3(2): 75-82.
[http://dx.doi.org/10.4103/ejode.ejode_16_17]
[7]
Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm--2016 executive summary. Endocr Pract 2016; 22(1): 84-113.
[http://dx.doi.org/10.4158/EP151126.CS] [PMID: 26731084]
[8]
Kostev K, Dippel FW. Predictors for the initiation of a basal supported oral therapy (BOT) in type 2 diabetic patients under real-life conditions in Germany. Prim Care Diabetes 2012; 6(4): 329-35.
[http://dx.doi.org/10.1016/j.pcd.2012.06.001] [PMID: 22749713]
[9]
Kuritzky L. Addition of basal insulin to oral antidiabetic agents: a goal-directed approach to type 2 diabetes therapy. MedGenMed 2006; 8(4): 34.
[PMID: 17415316]
[10]
Edelman SV. A practical approach to combination therapy: Daytime oral agent(s) and bedtime NPH insulin, clinical diabetes 1999; 17(3): 100.
[11]
Kalra S, Bahendeka S, Sahay R, et al. Consensus recommendations on sulfonylurea and sulfonylurea combinations in the management of type 2 diabetes mellitus – International Task Force. Indian J Endocrinol Metab 2018; 22(1): 132-57.
[http://dx.doi.org/10.4103/ijem.IJEM_556_17] [PMID: 29535952]
[12]
Venkataraman S, Devarajan TV, Kandasamy N, et al. Comparative evaluation of safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus: Indian multicentric randomized trial - START Study. Indian J Endocrinol Metab 2017; 21(5): 745-50.
[http://dx.doi.org/10.4103/ijem.IJEM_176_17] [PMID: 28989886]
[13]
Basit A, Riaz M, Fawwad A. Glimepiride: evidence-based facts, trends, and observations. Vasc Health Risk Manag 2012; 8: 463-72.
[http://dx.doi.org/10.2147/VHRM.S33194] [PMID: 23028231]
[14]
Umpierrez G, Issa M, Vlajnic A. Glimepiride versus pioglitazone combination therapy in subjects with type 2 diabetes inadequately controlled on metformin monotherapy: results of a randomized clinical trial. Curr Med Res Opin 2006; 22(4): 751-9.
[http://dx.doi.org/10.1185/030079906X104786] [PMID: 16684436]
[15]
Mishriky BM, Cummings DM, Tanenberg RJ. The efficacy and safety of DPP4 inhibitors compared to sulfonylureas as add-on therapy to metformin in patients with Type 2 diabetes: A systematic review and meta-analysis. Diabetes Res Clin Pract 2015; 109(2): 378-88.
[http://dx.doi.org/10.1016/j.diabres.2015.05.025] [PMID: 26059071]
[16]
Tripathi S, Tiwaskar M, Kota S, et al. Need of single pill fixed-dose combination with glimepiride in management of diabetes mellitus. J Assoc Physicians India 2019; S1: 30-3.
[17]
Sahay RK, Mittal V, Gopal GR, et al. Glimepiride and metformin combinations in diabetes comorbidities and complications: Real-world evidence. Cureus 2020; 12(9): e10700.
[http://dx.doi.org/10.7759/cureus.10700] [PMID: 33133865]
[18]
John M. Basal insulin analogues-a review of recent data on efficacy and safety. J Assoc Physicians India 2011; 59: 25-8.
[PMID: 21818995]
[19]
Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia 2008; 51(3): 408-16.
[http://dx.doi.org/10.1007/s00125-007-0911-x] [PMID: 18204830]
[20]
Aschner P, Sethi B, Gomez-Peralta F, et al. Insulin glargine compared with premixed insulin for management of insulin-naïve type 2 diabetes patients uncontrolled on oral antidiabetic drugs: the open-label, randomized GALAPAGOS study. J Diabetes Complications 2015; 29(6): 838-45.
[http://dx.doi.org/10.1016/j.jdiacomp.2015.04.003] [PMID: 25981123]
[21]
Fritsche A, Larbig M, Owens D, Häring HU. Comparison between a basal-bolus and a premixed insulin regimen in individuals with type 2 diabetes-results of the GINGER study. Diabetes Obes Metab 2010; 12(2): 115-23.
[http://dx.doi.org/10.1111/j.1463-1326.2009.01165.x] [PMID: 20092584]
[22]
Davies M, Lavalle-González F, Storms F, Gomis R. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the At.Lantus trial. Diabetes Obes Metab 2008; 10(5): 387-99.
[http://dx.doi.org/10.1111/j.1463-1326.2008.00873.x] [PMID: 18355327]
[23]
Hanefeld M, Monnier L, Schnell O, Owens D. Early treatment with basal insulin glargine in people with type 2 diabetes: Lessons from ORIGIN and other cardiovascular trials. Diabetes Ther 2016; 7(2): 187-201.
[http://dx.doi.org/10.1007/s13300-016-0153-3] [PMID: 26861811]
[24]
Kobayashi M, Tsukube S, Ikeda Y, Shuto Y. Safety and efficacy of combination therapy with insulin glargine and oral hypoglycaemic agents including DPP-4 inhibitors in Japanese T2DM patients: ALOHA 2 Study, a post-marketing surveillance for Lantus. J Diabetes Mellitus 2014; 4(4): 273-89.
[http://dx.doi.org/10.4236/jdm.2014.44039]
[25]
Seufert J, Wiesli P, Fritsche A, et al. Switching the basal insulin to insulin glargine 300 U/ml in people with type 2 diabetes under basal insulin supported oral therapy: Observational trial on effectiveness and safety. Diabetes Obes Metab 2022; 24(1): 72-81.
[http://dx.doi.org/10.1111/dom.14549] [PMID: 34514696]
[26]
Echtay A, Andari E, Atallah P, Moufarrege R, Nemr R. Insulin detemir in combination with oral antidiabetic drugs improves glycemic control in persons with type 2 diabetes in near East countries: Results from the Lebanese subgroup. Ethn Dis 2017; 27(1): 45-54.
[http://dx.doi.org/10.18865/ed.27.1.45] [PMID: 28115821]
[27]
Ritzel R, Roussel R, Bolli GB, et al. Patient‐level meta‐analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes. Diabetes Obes Metab 2015; 17(9): 859-67.
[http://dx.doi.org/10.1111/dom.12485] [PMID: 25929311]
[28]
Standl E, Owen DR. New long-acting basal insulins: Does benefit outweigh cost? Diabetes Care 2016; 39(S2): S172-9.
[http://dx.doi.org/10.2337/dcS15-3011] [PMID: 27440830]
[29]
Rosenstock J, Cheng A, Ritzel R, et al. More similarities than differences testing insulin glargine 300 units/ml versus insulin degludec 100 units/ml in insulin-naive type 2 diabetes: the randomized head-to-head bright trial. Diabetes Care 2018; 41(10): 2147-54.
[http://dx.doi.org/10.2337/dc18-0559] [PMID: 30104294]
[30]
Tsukube S, Kadowaki T, Odawara M. Efficacy and safety assessment of basal supported oral therapy (BOT) with insulin glargine in a real-life clinical setting, stratified by concomitant orally administered antidiabetic agent (OAD) regimens including dipeptidyl peptidase-4 inhibitor (DPP-4i): subanalysis of the ALOHA2 study, drug-use surveillance in Japan. Diabetol Int 2016; 7(3): 299-307.
[http://dx.doi.org/10.1007/s13340-015-0250-y] [PMID: 30603277]
[31]
Nybäck-Nakell Å, Adamson U, Lins PE, Landstedt-Hallin L. Adding glimepiride to insulin+metformin in type 2 diabetes of more than 10 years’ duration-A randomised, double-blind, placebo-controlled, cross-over study. Diabetes Res Clin Pract 2014; 103(2): 286-91.
[http://dx.doi.org/10.1016/j.diabres.2013.12.062] [PMID: 24485398]
[32]
Blonde L, Meneghini L, Peng XV, et al. Probability of achieving glycemic control with basal insulin in patients with type 2 diabetes in real-world practice in the USA. Diabetes Ther 2018; 9(3): 1347-58.
[http://dx.doi.org/10.1007/s13300-018-0413-5] [PMID: 29600507]
[33]
Yu HM, Kim SJ, Chun SW, et al. A comparison study on efficacy, insulin sensitivity and safety of Glimepiride/Metformin fixed dose combination versus glimepiride single therapy on type 2 diabetes mellitus patients with basal insulin therapy. Diabetes Res Clin Pract 2019; 155: 107796.
[http://dx.doi.org/10.1016/j.diabres.2019.107796] [PMID: 31326458]
[34]
Holman RR, Farmer AJ, Davies MJ, et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med 2009; 361(18): 1736-47.
[http://dx.doi.org/10.1056/NEJMoa0905479] [PMID: 19850703]
[35]
Owens DR, Traylor L, Dain MP, Landgraf W. Efficacy and safety of basal insulin glargine 12 and 24 weeks after initiation in persons with type 2 diabetes: A pooled analysis of data from treatment arms of 15 treat-to-target randomised controlled trials. Diabetes Res Clin Pract 2014; 106(2): 264-74.
[http://dx.doi.org/10.1016/j.diabres.2014.08.003] [PMID: 25195151]
[36]
Park CY, Kang JG, Chon S, et al. Comparison between the therapeutic effect of metformin, glimepiride and their combination as an add-on treatment to insulin glargine in uncontrolled patients with type 2 diabetes. PLoS One 2014; 9(3): e87799.
[http://dx.doi.org/10.1371/journal.pone.0087799] [PMID: 24614911]
[37]
Schiel R, Müller U. Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with type 2 diabetes previously on long-term conventional insulin therapy: the SWITCH Pilot Study. Exp Clin Endocrinol Diabetes 2008; 116(1): 58-64.
[http://dx.doi.org/10.1055/s-2007-985367] [PMID: 17973208]
[38]
Hammer H, Klinge A. Patients with type 2 diabetes inadequately controlled on premixed insulin: effect of initiating insulin glargine plus oral antidiabetic agents on glycaemic control in daily practice. Int J Clin Pract 2007; 61(12): 2009-18.
[http://dx.doi.org/10.1111/j.1742-1241.2007.01598.x] [PMID: 17997807]
[39]
Li CJ, Zhang JY, Yu DM, Zhang QM. Adding glimepiride to current insulin therapy increases high-molecular weight adiponectin levels to improve glycemic control in poorly controlled type 2 diabetes. Diabetol Metab Syndr 2014; 6(1): 41.
[http://dx.doi.org/10.1186/1758-5996-6-41] [PMID: 24650537]
[40]
Ose H, Fukui M, Kitagawa Y, et al. Efficacy of glimepiride in patients with poorly controlled insulin-treated type 2 diabetes mellitus. Endocr J 2005; 52(5): 563-9.
[http://dx.doi.org/10.1507/endocrj.52.563] [PMID: 16284434]
[41]
Bonnet F, Scheen A. Understanding and overcoming metformin gastrointestinal intolerance. Diabetes Obes Metab 2017; 19(4): 473-81.
[http://dx.doi.org/10.1111/dom.12854] [PMID: 27987248]
[42]
Rojas LBA, Gomes MB. Metformin: an old but still the best treatment for type 2 diabetes. Diabetol Metab Syndr 2013; 5(1): 6.
[http://dx.doi.org/10.1186/1758-5996-5-6] [PMID: 23415113]
[43]
Pantalone KM, Kattan MW, Yu C, et al. The risk of overall mortality in patients with type 2 diabetes receiving glipizide, glyburide, or glimepiride monotherapy: a retrospective analysis. Diabetes Care 2010; 33(6): 1224-9.
[http://dx.doi.org/10.2337/dc10-0017] [PMID: 20215447]
[44]
Fritsche A, Schweitzer MA, Hring H-U. Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Ann Intern Med 2003; 138(12): 952-9.
[http://dx.doi.org/10.7326/0003-4819-138-12-200306170-00006] [PMID: 12809451]
[45]
Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Järvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 2005; 28(2): 254-9.
[http://dx.doi.org/10.2337/diacare.28.2.254] [PMID: 15677775]
[46]
Lalau JD, Arnouts P, Sharif A, De Broe ME. Metformin and other antidiabetic agents in renal failure patients. Kidney Int 2015; 87(2): 308-22.
[http://dx.doi.org/10.1038/ki.2014.19] [PMID: 24599253]
[47]
Cheng AYY, Wong J, Freemantle N, Acharya SH, Ekinci E. The safety and efficacy of second-generation basal insulin analogues in adults with type 2 diabetes at risk of hypoglycemia and use in other special populations: a narrative review. Diabetes Ther 2020; 11(11): 2555-93.
[http://dx.doi.org/10.1007/s13300-020-00925-8] [PMID: 32975710]
[48]
Ritzel R, Harris SB, Baron H, et al. A Randomized controlled trial comparing efficacy and safety of insulin glargine 300 units/mL versus 100 units/mL in older people with type 2 diabetes: Results from the SENIOR study. Diabetes Care 2018; 41(8): 1672-80.
[http://dx.doi.org/10.2337/dc18-0168] [PMID: 29895556]
[49]
Wiesli P, Schories M. Improved glycemic control with insulin glargine 300 U/mL (Toujeo®) in patients with type 2 diabetes: Real-world effectiveness in Switzerland. Diabetes Ther 2018; 9(6): 2325-34.
[http://dx.doi.org/10.1007/s13300-018-0518-x] [PMID: 30302721]
[50]
Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SCL. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging 2013; 30(12): 1009-18.
[http://dx.doi.org/10.1007/s40266-013-0128-2] [PMID: 24170235]
[51]
International Diabetes Federation. Diabetes and Ramadan: practical guidance 2016. Available at https://www.idf.org/e-library/guide lines/87-diabetes-and-ramadan-practical-25.html. Accessed on March 2022.
[52]
Diabetes and Ramadan. Practical Guidelines 2021. Available at https://www.idf.org/our-activities/education/diabetes-and-ramadan/healthcare-professionals.html Accessed on Jan 2023.
[53]
Hassanein M, Buyukbese MA, Malek R, et al. Real-world safety and effectiveness of insulin glargine 300 U/mL in participants with type 2 diabetes who fast during Ramadan: The observational ORION study. Diabetes Res Clin Pract 2020; 166: 108189.
[http://dx.doi.org/10.1016/j.diabres.2020.108189] [PMID: 32360709]
[54]
Majumder A, RoyChaudhuri S, Sanyal D, RoyChaudhuri S, Sanyal D. A retrospective observational study of insulin glargine in type 2 diabetic patients with advanced chronic kidney disease. Cureus 2019; 11(11): e6191.
[PMID: 31890395]
[55]
Haluzík M, Cheng A, Müller-Wieland D, et al. Differential glycaemic control with basal insulin glargine 300 U/mL versus degludec 100 U/mL according to kidney function in type 2 diabetes: A subanalysis from the BRIGHT trial. Diabetes Obes Metab 2020; 22(8): 1369-77.
[http://dx.doi.org/10.1111/dom.14043] [PMID: 32243043]
[56]
Sola D, Rossi L, Schianca GPC, et al. State of the art paper Sulfonylureas and their use in clinical practice. Arch Med Sci 2015; 4(4): 840-8.
[http://dx.doi.org/10.5114/aoms.2015.53304] [PMID: 26322096]
[57]
Cerghizan A, Amorin P, Catrinoiu D, Creteanu G, Adamescu E, Moise M. Efficacy and safety of basal insulin therapy in Romanian patients with type 2 diabetes in real-life settings: a sub-group analysis of dune study. Acta Endocrinol 2020; 16(1): 43-8.
[http://dx.doi.org/10.4183/aeb.2020.43] [PMID: 32685037]
[58]
Odawara M, Kadowaki T, Naito Y. Effectiveness and safety of basal supported oral therapy with insulin glargine, in Japanese insulin-naive, type 2 diabetes patients, with or without microvascular complications: subanalysis of the observational, non-interventional, 24-week follow-up Add-on Lantus® to Oral Hypoglycemic Agents (ALOHA) study. J Diabetes Complications 2015; 29(1): 127-33.
[http://dx.doi.org/10.1016/j.jdiacomp.2014.09.012] [PMID: 25449981]
[59]
Kim SS, Kim IJ, Kim YK, et al. Insulin initiation in insulin-naïve Korean type 2 diabetic patients inadequately controlled on oral antidiabetic drugs in real-world practice: The modality of insulin treatment evaluation study. Diabetes Metab J 2015; 39(6): 481-8.
[http://dx.doi.org/10.4093/dmj.2015.39.6.481] [PMID: 26616594]
[60]
Bethel MA, Feinglos MN. Basal insulin therapy in type 2 diabetes. J Am Board Fam Med 2005; 18(3): 199-204.
[http://dx.doi.org/10.3122/jabfm.18.3.199] [PMID: 15879567]
[61]
Hermansen K, Madsbad S, Perrild H, Kristensen A, Axelsen M. Comparison of the soluble basal insulin analog insulin detemir with NPH insulin: a randomized open crossover trial in type 1 diabetic subjects on basal-bolus therapy. Diabetes Care 2001; 24(2): 296-301.
[http://dx.doi.org/10.2337/diacare.24.2.296] [PMID: 11213882]
[62]
Nasrallah SN, Reynolds LR. Insulin degludec, The new generation basal insulin or just another basal insulin? Clin Med Insights Endocrinol Diabetes 2012; 5: CMED.S9494.
[http://dx.doi.org/10.4137/CMED.S9494] [PMID: 22879797]
[63]
Scheen AJ. Insuline glargine 300 U/mL (Toujeo®). Rev Med Liege 2016; 71(2): 101-7.
[PMID: 27141654]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy