Effectiveness and Safety of Add-on Once-Daily Liraglutide (1.2 mg) in Type 2 Diabetes Patients with Obesity: Data from a Real-World Cohort of Iraqi Patients
Abstract
Objective: This study aimed to evaluate real-world effectiveness and safety of once-daily liraglutide (1.2 mg) as an add-on to oral antidiabetic drugs (OADs) and/or insulin, in type 2 diabetes (T2D) patients with obesity in Iraq. Materials and methods: A total of 55 T2D patients with obesity (mean ± SD age: 46.5 ± 8.7 years, 60% were females) initiating once-daily liraglutide (1.2 mg) as an add-on to OADs and/or insulin were included in this prospective cohort study. Change in body weight and serum HbA1c levels, and the insulin and sulfonylurea (SU) requirement were recorded during 24-week liraglutide therapy. Results: Liraglutide yielded significant reduction in HbA1c values (from 10.7 ± 2.0% at baseline to 8.7 ± 2.4 % and 8.1 ± 1.6 % at weeks 12 and 24, respectively, p < 0.001 for each) and body weight (from 112.0 ± 19.6 kg at baseline to 109 ± 19.1 kg, 102 ± 16.9 kg and 97.0 ± 15.8 kg at weeks 4, 12 and 24, respectively, p < 0.001 for each). SU was stopped in 9/17 (52.9%) patients, and insulin therapy was discontinued in 15/44 (34%) patients after liraglutide treatment, and either with discontinuation or switch to basal insulin, 22/34 (64.7%) patients were no longer
requiring prandial insulin (premixed and basal/bolus). No unexpected safety or tolerability issues occurred. Conclusions: In conclusion, our findings support the consideration of liraglutide as a favorable intensifying therapy in T2D patients with obesity and metformin failure, given that it enables a sustained HbA1c and body weight reduction even at 1.2 mg once-daily dose, alongside the potential benefits in reducing SU and insulin requirements with no serious side effects.
Keywords: type 2 diabetesobesityliraglutide 1.2 mg daily doseefficacyreal-worldIraq
References
- Lazzaroni E, Ben Nasr M, Loretelli C, et al. Anti-diabetic drugs and weight loss in patients with type 2 diabetes. Pharmacol Res. 2021; 171: 105782.
- Evert AB, Franz MJ. Why Weight Loss Maintenance Is Difficult. Diabetes Spectr. 2017; 30(3): 153–156.
- Bailey CJ, Flatt PR, Conlon JM. An update on peptide-based therapies for type 2 diabetes and obesity. Peptides. 2023; 161: 170939.
- Iglay K, Hannachi H, Joseph Howie P, et al. Prevalence and co-prevalence of comorbidities among patients with type 2 diabetes mellitus. Curr Med Res Opin. 2016; 32(7): 1243–1252.
- Davies MJ, D'Alessio DA, Fradkin J, et al. 30291106. Diabetes Care. 2018; 41(12): 2669–2701.
- American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: . Diabetes Care. 2021; 44(Suppl 1): S111–S124.
- Davies MJ, Bergenstal R, Bode B, et al. NN8022-1922 Study Group. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial. JAMA. 2015; 314(7): 687–699.
- Howell R, Wright AM, Clements JN. Clinical potential of liraglutide in cardiovascular risk reduction in patients with type 2 diabetes: evidence to date. Diabetes Metab Syndr Obes. 2019; 12: 505–512.
- Silva-Nunes J, Nascimento E, Louro J, et al. Liraglutide Effectiveness in Type 2 Diabetes: Insights from a Real-World Cohort of Portuguese Patients. Metabolites. 2022; 12(11).
- Zhou F, Jiang Lu, Guo J, et al. Degree of obesity and gastrointestinal adverse reactions influence the weight loss effect of liraglutide in overweight or obese patients with type 2 diabetes. Ther Adv Chronic Dis. 2023; 14: 20406223231161516.
- Rahmah A, Al-Isawi J, Mahdi O. The efficacy of once-daily liraglutide as an add-on to oral antidiabetic agents on weight reduction and glycemic control in obese patients with inadequately controlled type 2 diabetes: a retrospective analysis in relation to liraglutide dose escalation within a 7-month treatment period. International Journal of Diabetes in Developing Countries. 2020; 41(2): 266–272.
- Bashier AMK, Hussain AA, Abdelgadir EI, et al. Liraglutide effect in reducing HbA1c and weight in Arab population with type2 diabetes, a prospective observational trial. J Diabetes Metab Disord. 2015; 14: 48.
- Yousef CC, Thomas A, Matar MAl, et al. Liraglutide effects on glycemic control and weight in patients with type 2 diabetes Mellitus: A real-world, observational study and brief narrative review. Diabetes Res Clin Pract. 2021; 177: 108871.
- Ostawal A, Mocevic E, Kragh N, et al. Clinical Effectiveness of Liraglutide in Type 2 Diabetes Treatment in the Real-World Setting: A Systematic Literature Review. Diabetes Ther. 2016; 7(3): 411–438.
- Sethi BK, Viswanathan V, Kumar A, et al. Liraglutide in clinical practice: insights from LEAD programme. J Assoc Physicians India. 2010; 58: 18–22.
- Capehorn MS, Catarig AM, Furberg JK, et al. Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10). Diabetes Metab. 2020; 46(2): 100–109.
- Gu J, Meng X, Guo Y, et al. The efficacy and safety of liraglutide added to metformin in patients with diabetes: a meta-analysis of randomized controlled trials. Sci Rep. 2016; 6: 32714.
- Russell-Jones D, Khan R. Insulin-associated weight gain in diabetes--causes, effects and coping strategies. Diabetes Obes Metab. 2007; 9(6): 799–812.
- Zinman B, Gerich J, Buse JB, et al. LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009; 32(7): 1224–1230.
- Russell-Jones D, Vaag A, Schmitz O, et al. Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009; 52(10): 2046–2055.
- Nauck M, Frid A, Hermansen K, et al. LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009; 32(1): 84–90.
- Nauck MA, Quast DR, Wefers J, et al. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Mol Metab. 2021; 46: 101102.
- Gough SCL, Bode B, Woo V, et al. NN9068-3697 (DUAL-I) trial investigators. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol. 2014; 2(11): 885–893.
- Abusnana S, Al Awadi F, Aly H, et al. Switching to a fixed-ratio combination of insulin degludec/liraglutide (IDegLira) is associated with improved glycaemic control in a real-world population with type 2 diabetes mellitus in the United Arab Emirates: Results from the multicentre, prospective INTENSIFY study. Diabetes Res Clin Pract. 2023; 196: 110183.
- Garvey WT, Birkenfeld AL, Dicker D, et al. Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial. Diabetes Care. 2020; 43(5): 1085–1093.
- Martinka E, Dravecká I, Tkáč I. Switching from Multiple Insulin Injections to a Fixed Combination of Degludec and Liraglutide in Patients with Type 2 Diabetes Mellitus: Results from the Simplify Study After 6 Months. Diabetes Ther. 2023; 14(9): 1503–1515.
- Unger J, Allison DC, Kaltoft M, et al. LIRA-PRIME investigators. Maintenance of glycaemic control with liraglutide versus oral antidiabetic drugs as add-on therapies in patients with type 2 diabetes uncontrolled with metformin alone: A randomized clinical trial in primary care (LIRA-PRIME). Diabetes Obes Metab. 2022; 24(2): 204–211.
- Ciresi A, Vigneri E, Radellini S, et al. Liraglutide Improves Cardiovascular Risk as an Add-on to Metformin and Not to Insulin Secretagogues in Type 2 Diabetic Patients: A Real-life 48-Month Retrospective Study. Diabetes Ther. 2018; 9(1): 363–371.
- Simioni N, Berra C, Boemi M, et al. ReaL (NN2211-4118) Study Group*. Predictors of treatment response to liraglutide in type 2 diabetes in a real-world setting. Acta Diabetol. 2018; 55(6): 557–568.
- Wu H, Lu Z, Chen R, et al. Factors associated with gastrointestinal side effects after liraglutide treatment for type 2 diabetes. Front Endocrinol (Lausanne). 2023; 14: 1098032.