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IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy.

ABSTRACT:

Introduction

IDegLira is a once-daily combination of insulin degludec (IDeg) and liraglutide. Trials directly comparing IDegLira with alternative strategies for intensifying basal insulin are ongoing. While awaiting results, this analysis compared indirectly how different strategies affected glycated hemoglobin (HbA_1c) and other outcomes.

Methods

A pooled analysis of five completed Novo Nordisk randomized clinical trials in patients with type 2 diabetes inadequately controlled on basal insulin was used to compare indirectly IDegLira (N = 199) with: addition of liraglutide to basal insulin (N = 225) [glucagon-like peptide-1 receptor agonist (GLP-1RA) add-on strategy]; basal-bolus (BB) insulin [insulin glargine (IGlar) + insulin aspart] (N = 56); or up-titration of IGlar (N = 329). A supplementary analysis was performed with the BB arm including patients who received IGlar or IDeg as basal insulin in the relevant trial (N = 210). All trials had comparable inclusion/exclusion criteria and baseline characteristics. Individual patient-level data were analyzed using multivariable statistical models with potential baseline heterogeneity accounted for using explanatory variables.

Results

At end of study, differences between IDegLira and BB or up-titrated IGlar, respectively, were as follows: reduction in HbA_1c -0.30%, 95% confidence interval (-0.58; -0.01) and -0.65% (-0.83; -0.47); change in body weight -6.89 kg (-7.92; -5.86) and -4.04 kg (-4.69; -3.40) all in favor of IDegLira. Confirmed hypoglycemia rate was 122.8 (90.7; 166.1), 1060.8 (680.2; 1654.4), and 286.1 (231.1; 354.1) events/100 patient-years for IDegLira, BB, and up-titrated IGlar, respectively. Odds ratios for achieving HbA_1c <7.0%, <7.0% without hypoglycemia, and <7.0% without hypoglycemia and no weight gain were greater with IDegLira versus up-titrated IGlar. The supplementary analysis yielded similar results to the main analysis. Results with IDegLira were similar to those for the 'GLP-1RA add-on' arm.

Conclusion

These results suggest that IDegLira may be more effective, with lower hypoglycemia rates and less weight gain, than up-titrated basal insulin or BB in patients uncontrolled on basal insulin.

SUBMITTER: Freemantle N

PROVIDER: S-EPMC4674480 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesAchieving glycemic control in patients with type 2 diabetes is important as it reduces the risk of complications and their related clinical and economic burden. Yet therapeutic inertia due to the fear of hypoglycemia, complex treatment regimens, weight gain, and therapy costs, among others, limits achieving glycemic control. This analysis aims to assess the short-term cost of control (cost per patient achieving treatment goals) with insulin degludec/liraglutide (IDegLira) versus other forms of basal insulin intensification (insulin glargine titration, basal-bolus therapy, and the combination of insulin glargine and lixisenatide: IGlarLixi) in type 2 diabetes patients not controlled with basal insulin in the Mexican private setting.MethodsThe proportion of patients achieving treatment goals was obtained from DUAL V and DUAL VII studies (full trial population) and a indirect treatment comparison analyzing IDegLira versus IGlarLixi. Annual cost of treatment was estimated using unitary costs from IQVIA's Pharmaceutical Market Mexico (PMM) audit and wholesale acquisition costs (both from December 2021). The cost of control was estimated by dividing the annual cost of treatment by the proportion of patients achieving the corresponding treatment goal: glycated hemoglobin (HbA1C) < 7.0%, HbA1C < 7.0% without weight gain, HbA1C < 7.0% without hypoglycemia, and HbA1C < 7.0% without hypoglycemia and weight gain. One-way sensitivity analyses were conducted to assess how variations in the model inputs impacted cost-effectiveness outcomes.ResultsThe proportion of patients achieving treatment goals was higher for IDegLira versus other forms of basal insulin intensification in all endpoints assessed. The annual cost of treatment with IDegLira was similar to the cost of treatment versus IGlarLixi or versus basal-bolus therapy ($54,659 versus $55,831 MXN and $51,008 versus $52,987 MXN, respectively), and higher in comparison with insulin glargine titration ($52,186 versus $40,194 MXN). The cost of controlling one patient with IDegLira was lower than any other form of basal insulin intensification, for all treatment goals.ConclusionWhen integrating the greater clinical efficacy of IDegLira with its annual cost, it can be shown that within 1 year, IDegLira is the best option in terms of value for money for payers in a private healthcare setting in Mexico in comparison with other forms of basal insulin intensification. Thus, investing in IDegLira not only represents a greater clinical benefit, but also an economical one for payers.

Project description:IntroductionFew patients with type 2 diabetes mellitus (T2DM) achieve recommended glycemic control targets in the Czech Republic. Novel therapies, such as fixed-ratio combinations of basal insulin plus glucagon-like peptide-1 receptor agonists, may contribute to better glycemic control. In the analysis presented here, the present analysis assessed the long-term cost-effectiveness of two fixed-ratio combinations, IDegLira (insulin degludec/liraglutide) and iGlarLixi (insulin glargine/lixisenatide), for the treatment of patients with T2DM inadequately controlled with basal insulin from a healthcare payer perspective in the Czech Republic.MethodsA cost-effectiveness analysis was performed over patient lifetimes using the IQVIA CORE Diabetes Model. Treatment effects were obtained from an indirect treatment comparison as no head-to-head data for IDegLira versus iGlarLixi are currently available. IDegLira was compared with two iGlarLixi pens (100 U/mL insulin glargine + 33 μg/mL and 50 μg/mL of lixisenatide, respectively). Direct medical costs associated with pharmaceutical interventions, screening and diabetes-related complications were captured. Deterministic and probabilistic sensitivity analyses were performed.ResultsIDegLira was associated with gains in life expectancy of 0.11 years and in quality-adjusted life expectancy of 0.14 quality-adjusted life-years (QALYs) versus iGlarLixi, due to a lower cumulative incidence and delayed onset of diabetes-related complications. IDegLira was also associated with higher projected costs due to higher acquisition costs; however, these were partially offset by cost savings from avoided complications. IDegLira was associated with incremental cost-effectiveness ratios of Czech Koruna (CZK) 695,998 and CZK 348,323 per QALY gained versus iGlarLixi pens containing 33 and 50 μg/mL of lixisenatide, respectively. These ratios were below the commonly used willingness-to-pay threshold of CZK 1,200,000 per QALY gained.ConclusionThe present analysis indicated that IDegLira was associated with clinical benefits relative to iGlarLixi over patient lifetimes and was likely to be cost-effective in the treatment of patients with T2DM uncontrolled on basal insulin in the Czech Republic.FundingNovo Nordisk. Plain language summary is available for this article.