Dataset Information

Switching from Neutral Protamine Hagedorn (NPH) Insulin to Insulin Glargine 300 U/mL in Older and Younger Patients with Type 2 Diabetes: A Post Hoc Analysis of a Multicenter, Prospective, Observational Study.

ABSTRACT:

Introduction

Older age and longer disease duration are key risk factors for hypoglycemia in patients with type 2 diabetes (T2D) who receive insulin. Previous studies have shown that insulin glargine 300 U/mL (Gla-300) improves glycemic control and reduces the risk of hypoglycemia, but whether this effect is observed in older patients switching from neutral protamine Hagedorn (NPH) insulin is unclear.

Methods

In this multicenter, observational study involving patients with T2D aged ≥ 18 years with glycated hemoglobin (HbA_1c) ≥ 8%, we compared the safety and effectiveness of switching from NPH insulin to Gla-300 in subgroups of patients differing by age (< 65 vs. ≥ 65 years) and duration of diabetes (≤ 13 vs. > 13 years).

Results

A total of 469 participants were included in the study. From baseline to 6 months after switching to Gla-300, mean HbA_1c decreased from 9.23% to 8.13% (p < 0.001) among patients aged ≤ 65 years (224 patients), and from 9.15% to 8.20% (p < 0.001) among those aged > 65 years (245 patients). The proportion of patients with ≥ 1 episodes of hypoglycemia decreased from 19.1% to 13.6% (p = 0.11) among those aged ≤ 65 years, and from 26.9% to 13.0% (p < 0.001) among those aged > 65 years; the reduction was significantly greater in those aged > 65 years (p = 0.001). The reduction in HbA_1c was greater in those with a disease duration ≤ 13 years (p = 0.007), but the reduction in hypoglycemia was greater in those with a disease duration > 13 years (p < 0.0003).

Conclusion

The switch from NPH insulin to Gla-300 improved glycemic control in older patients with T2D and in those with a longer disease duration. Older patients with T2D and those with a longer disease duration benefited even more from the switch to Gla-300 than younger patients and those with a shorter disease duration, with significantly greater reductions in the risk of hypoglycemia.

SUBMITTER: Wolnik B

PROVIDER: S-EPMC8873339 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

Switching from Neutral Protamine Hagedorn (NPH) Insulin to Insulin Glargine 300 U/mL in Older and Younger Patients with Type 2 Diabetes: A Post Hoc Analysis of a Multicenter, Prospective, Observational Study.

Wolnik B B Hryniewiecki A A Pisarczyk-Wiza D D Szczepanik T T Klupa T T

Diabetes therapy : research, treatment and education of diabetes and related disorders 20220116 2

<h4>Introduction</h4>Older age and longer disease duration are key risk factors for hypoglycemia in patients with type 2 diabetes (T2D) who receive insulin. Previous studies have shown that insulin glargine 300 U/mL (Gla-300) improves glycemic control and reduces the risk of hypoglycemia, but whether this effect is observed in older patients switching from neutral protamine Hagedorn (NPH) insulin is unclear.<h4>Methods</h4>In this multicenter, observational study involving patients with T2D aged ...[more]

PMID: 35034328

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Project description:Aims/hypothesisThis long-term study was designed to further characterise the retinal safety profile of insulin glargine and human neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes mellitus.MethodsAn open-label, 5 year, randomised (1:1), multicentre, stratified, parallel-group study conducted in the USA and Canada enrolled individuals with type 2 diabetes and either no or non-proliferative retinopathy (less than severe; Early Treatment Diabetic Retinopathy Study [ETDRS] level less than 53 in both eyes) who were treated with oral hypoglycaemic agents (OHAs) alone, insulin alone or OHAs with insulin for >/=3 months prior to study entry and a baseline HbA(1c) level of 6.0-12.0%. Patients were randomised by the investigator according to the centralised interactive voice response system to receive twice-daily NPH insulin (n = 509) or once-daily basal insulin glargine (n = 515). The investigator was not blinded to the treatment group to which each participant had been assigned. The main objective of this study was to compare the progression of diabetic retinopathy between treatment groups by analysing the percentage of patients with three or more step progression in the ETDRS retinopathy patient-level severity scale after treatment with either basal insulin. Masked, centralised grading of seven-field stereoscopic fundus photographs was used.ResultsSimilarly sustained glycaemic control was observed in both the insulin glargine and NPH insulin treatment groups. Despite a slightly greater severity of diabetic retinopathy for the insulin glargine group at baseline, three or more step progression in ETDRS score from baseline to end-of-study was similar between treatment groups (14.2% [53/374] of insulin glargine-treated patients vs 15.7% [57/363] of NPH-treated patients); the difference in the incidence of progression was -1.98% (95% CI -7.02, 3.06%). Other measures of retinopathy-the development of proliferative diabetic retinopathy and progression to clinically significant macular oedema-occurred to a similar degree in both treatment groups. No other safety issues, such as unexpected adverse events for either insulin emerged during the 5 year study. However, NPH insulin treatment was associated with a higher incidence of severe hypoglycaemia compared with insulin glargine.Conclusions/interpretationThis study shows no evidence of a greater risk of the development or progression of diabetic retinopathy with insulin glargine vs NPH insulin treatment in patients with type 2 diabetes mellitus.Trial registrationClinicalTrials.gov NCT00174824FundingThis study was sponsored by sanofi-aventis.

Project description:ImportancePrevious studies have found that the risk of severe hypoglycemia does not differ between long-acting insulin analogs and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes. However, these studies did not focus on patients 65 years or older, who are at an increased risk for hypoglycemia, or did not include patients with concomitant prandial insulin use.ObjectiveTo examine the risk of emergency department (ED) visits or hospitalizations for hypoglycemia among older community-residing patients with type 2 diabetes who initiated long-acting insulin or NPH insulin in real-world settings.Design, setting, and participantsThis retrospective, new-user cohort study assessed Medicare beneficiaries 65 years or older who initiated insulin glargine (n = 407 018), insulin detemir (n = 141 588), or NPH insulin (n = 26 402) from January 1, 2007, to July 31, 2019.ExposuresInsulin glargine, insulin detemir, and NPH insulin.Main outcomes and measuresThe primary outcome was time to first ED visit or hospitalization for hypoglycemia, defined using a modified validated algorithm. Propensity score-weighted Cox proportional hazards regression was used to estimate hazard ratios (HRs) and 95% CIs. The risk of recurring hypoglycemia events was estimated using the Andersen-Gill model. Post hoc analyses were conducted investigating possible effect modification by age.ResultsOf the 575 008 patients initiating use of insulin (mean [SD] age 74.9 [6.7] years; 53% female), 407 018 used glargine, 141 588 used detemir, and 26 402 used NPH insulin. The study included 7347 ED visits or hospitalizations for hypoglycemia (5194 for glargine, 1693 for detemir, and 460 for NPH insulin, with a median follow-up across the 3 cohorts of 0.37 years (interquartile range, 0.20-0.76 years). Initiation of glargine and detemir use was associated with a reduced risk of hypoglycemia compared with NPH insulin use (HR for glargine vs NPH insulin, 0.71; 95% CI, 0.63-0.80; HR, detemir vs NPH insulin, 0.72; 95% CI, 0.63-0.82). The HRs were similar for the recurrent event analysis. The protective association of long-acting insulin analogs varied by age and was not seen with concomitant prandial insulin use.Conclusions and relevanceIn this cohort study, initiation of long-acting analogs was associated with a lower risk of ED visits or hospitalizations for hypoglycemia compared with NPH insulin in older patients with type 2 diabetes in Medicare. However, this association was not seen with concomitant prandial insulin use.

Project description:ObjectivesTo compare real-world outcomes of initiating insulin glargine (GLA) versus neutral protamine Hagedorn (NPH) insulin among employees with type 2 diabetes mellitus (T2DM) who had both employer-sponsored health insurance and short-tem-disability coverages.DesignRetrospective cohort study.SettingMarketScan Commercial Claims and Encounters/Health and Productivity Management Databases 2003-2009.ParticipantsAdult employees with T2DM who were previously treated with oral antidiabetic drugs and/or glucagon-like-peptide 1 receptor agonists and initiated GLA or NPH were included if they were continuously enrolled in healthcare and short-term-disability coverages for 3 months before (baseline) and 1 year after (follow-up) initiation. Treatment selection bias was addressed by 2:1 propensity score matching. Sensitivity analyses were conducted using different matching ratios.Primary and secondary outcome measuresOutcomes during 1-year follow-up were measured and compared: insulin treatment persistence and adherence; hypoglycaemia rates and daily average consumption of insulin; total and diabetes-specific healthcare resource utilisation and costs and loss in productivity, as measured by short-term disability, and the associated costs.ResultsA total of 534 patients were matched and analysed (GLA: 356; NPH 178) with no significant differences in baseline characteristics. GLA patients were more persistent and adherent (both p<0.05), had lower rates of hospitalisation (23% vs 31.4%; p=0.036) and endocrinologist visits (19.1% vs 26.9%; p=0.038), similar hypoglycaemia rates (both 4.4%; p=1.0), higher diabetes drug costs ($2031 vs $1522; p<0.001), but similar total healthcare costs ($14 550 vs $16 093; p=0.448) and total diabetes-related healthcare costs ($4686 vs $5604; p=0.416). Short-term disability days and costs were numerically lower in the GLA cohort (16.0 vs 24.5 days; p=0.086 and $2824 vs $4363; p=0.081, respectively). Sensitivity analyses yielded similar findings.ConclusionsInsulin GLA results in better persistence and adherence, compared with NPH insulin, with no overall cost disadvantages. Better persistence and adherence may lead to long-term health benefits for employees with T2DM.

Dataset Information

Switching from Neutral Protamine Hagedorn (NPH) Insulin to Insulin Glargine 300 U/mL in Older and Younger Patients with Type 2 Diabetes: A Post Hoc Analysis of a Multicenter, Prospective, Observational Study.

Introduction

Methods

Results

Conclusion

Publications

Switching from Neutral Protamine Hagedorn (NPH) Insulin to Insulin Glargine 300 U/mL in Older and Younger Patients with Type 2 Diabetes: A Post Hoc Analysis of a Multicenter, Prospective, Observational Study.

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