Rates of Hypoglycemia Predicted in Patients with Type 2 Diabetes on Insulin Glargine 300 U/ml Versus First- and Second-Generation Basal Insulin Analogs: The Real-World LIGHTNING Study

Jeremy Pettus, Ronan Roussel, Fang Liz Zhou, Zsolt Bosnyak, Jukka Westerbacka, Rachele Berria, Javier Jimenez, Björn Eliasson, Irene Hramiak, Timothy Bailey, Luigi F Meneghini

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Introduction: The LIGHTNING study applied conventional and advanced analytic approaches to model, predict, and compare hypoglycemia rates of people with type 2 diabetes (T2DM) on insulin glargine 300 U/ml (Gla-300) with those on first-generation (insulin glargine 100 U/ml [Gla-100]; insulin detemir [IDet]) or second-generation (insulin degludec [IDeg]) basal-insulin (BI) analogs, utilizing a large real-world database. Methods: Data were collected between 1 January 2007 and 31 March 2017 from the Optum Humedica US electronic health records [EHR] database. Patient-treatments, the period during which a patient used a specific BI, were analyzed for patients who switched from a prior BI or those who newly initiated BI therapy. Data were analyzed using two approaches: propensity score matching (PSM) and a predictive modeling approach using machine learning. Results: A total of 831,456 patients with T2DM receiving BI were included from the EHR data set. Following selection, 198,198 patient-treatments were available for predictive modeling. The analysis showed that rates of severe hypoglycemia (using a modified definition) were approximately 50% lower with Gla-300 than with Gla-100 or IDet in insulin-naïve individuals, and 30% lower versus IDet in BI switchers (all p < 0.05). Similar rates of severe hypoglycemia were predicted for Gla-300 and IDeg, regardless of prior insulin experience. Similar results to those observed in the overall cohorts were seen in analyses across subgroups at a particularly high risk of hypoglycemia. PSM (performed on 157,573 patient-treatments) revealed comparable reductions in HbA 1c with Gla-300 versus first- and second-generation BI analogs, alongside lower rates of severe hypoglycemia with Gla-300 versus first-generation BI analogs (p < 0.05) and similar rates versus IDeg in insulin-naïve and BI-switcher cohorts. Conclusions: Based on real-world data, predicted rates of severe hypoglycemia with Gla-300 tended to be lower versus first-generation BI analogs and similar versus IDeg in a wide spectrum of patients with T2DM. Funding: Sanofi, Paris, France.

Original languageEnglish (US)
Pages (from-to)617-633
Number of pages17
JournalDiabetes Therapy
Volume10
Issue number2
DOIs
StatePublished - Apr 1 2019

Fingerprint

Hypoglycemia
Type 2 Diabetes Mellitus
Insulin
Propensity Score
Electronic Health Records
Insulin Glargine
Databases
Paris
Therapeutics
France

Keywords

  • Basal insulin
  • Insulin degludec
  • Insulin detemir
  • Insulin glargine
  • Machine learning
  • Predictive modeling
  • Real-world evidence
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Rates of Hypoglycemia Predicted in Patients with Type 2 Diabetes on Insulin Glargine 300 U/ml Versus First- and Second-Generation Basal Insulin Analogs : The Real-World LIGHTNING Study. / Pettus, Jeremy; Roussel, Ronan; Liz Zhou, Fang; Bosnyak, Zsolt; Westerbacka, Jukka; Berria, Rachele; Jimenez, Javier; Eliasson, Björn; Hramiak, Irene; Bailey, Timothy; Meneghini, Luigi F.

In: Diabetes Therapy, Vol. 10, No. 2, 01.04.2019, p. 617-633.

Research output: Contribution to journalArticle

Pettus, Jeremy ; Roussel, Ronan ; Liz Zhou, Fang ; Bosnyak, Zsolt ; Westerbacka, Jukka ; Berria, Rachele ; Jimenez, Javier ; Eliasson, Björn ; Hramiak, Irene ; Bailey, Timothy ; Meneghini, Luigi F. / Rates of Hypoglycemia Predicted in Patients with Type 2 Diabetes on Insulin Glargine 300 U/ml Versus First- and Second-Generation Basal Insulin Analogs : The Real-World LIGHTNING Study. In: Diabetes Therapy. 2019 ; Vol. 10, No. 2. pp. 617-633.
@article{bc7575aef6a549149fcfa9b786225f7b,
title = "Rates of Hypoglycemia Predicted in Patients with Type 2 Diabetes on Insulin Glargine 300 U/ml Versus First- and Second-Generation Basal Insulin Analogs: The Real-World LIGHTNING Study",
abstract = "Introduction: The LIGHTNING study applied conventional and advanced analytic approaches to model, predict, and compare hypoglycemia rates of people with type 2 diabetes (T2DM) on insulin glargine 300 U/ml (Gla-300) with those on first-generation (insulin glargine 100 U/ml [Gla-100]; insulin detemir [IDet]) or second-generation (insulin degludec [IDeg]) basal-insulin (BI) analogs, utilizing a large real-world database. Methods: Data were collected between 1 January 2007 and 31 March 2017 from the Optum Humedica US electronic health records [EHR] database. Patient-treatments, the period during which a patient used a specific BI, were analyzed for patients who switched from a prior BI or those who newly initiated BI therapy. Data were analyzed using two approaches: propensity score matching (PSM) and a predictive modeling approach using machine learning. Results: A total of 831,456 patients with T2DM receiving BI were included from the EHR data set. Following selection, 198,198 patient-treatments were available for predictive modeling. The analysis showed that rates of severe hypoglycemia (using a modified definition) were approximately 50{\%} lower with Gla-300 than with Gla-100 or IDet in insulin-na{\"i}ve individuals, and 30{\%} lower versus IDet in BI switchers (all p < 0.05). Similar rates of severe hypoglycemia were predicted for Gla-300 and IDeg, regardless of prior insulin experience. Similar results to those observed in the overall cohorts were seen in analyses across subgroups at a particularly high risk of hypoglycemia. PSM (performed on 157,573 patient-treatments) revealed comparable reductions in HbA 1c with Gla-300 versus first- and second-generation BI analogs, alongside lower rates of severe hypoglycemia with Gla-300 versus first-generation BI analogs (p < 0.05) and similar rates versus IDeg in insulin-na{\"i}ve and BI-switcher cohorts. Conclusions: Based on real-world data, predicted rates of severe hypoglycemia with Gla-300 tended to be lower versus first-generation BI analogs and similar versus IDeg in a wide spectrum of patients with T2DM. Funding: Sanofi, Paris, France.",
keywords = "Basal insulin, Insulin degludec, Insulin detemir, Insulin glargine, Machine learning, Predictive modeling, Real-world evidence, Type 2 diabetes",
author = "Jeremy Pettus and Ronan Roussel and {Liz Zhou}, Fang and Zsolt Bosnyak and Jukka Westerbacka and Rachele Berria and Javier Jimenez and Bj{\"o}rn Eliasson and Irene Hramiak and Timothy Bailey and Meneghini, {Luigi F}",
year = "2019",
month = "4",
day = "1",
doi = "10.1007/s13300-019-0568-8",
language = "English (US)",
volume = "10",
pages = "617--633",
journal = "Diabetes Therapy",
issn = "1869-6953",
publisher = "Springer Publishing Company",
number = "2",

}

TY - JOUR

T1 - Rates of Hypoglycemia Predicted in Patients with Type 2 Diabetes on Insulin Glargine 300 U/ml Versus First- and Second-Generation Basal Insulin Analogs

T2 - The Real-World LIGHTNING Study

AU - Pettus, Jeremy

AU - Roussel, Ronan

AU - Liz Zhou, Fang

AU - Bosnyak, Zsolt

AU - Westerbacka, Jukka

AU - Berria, Rachele

AU - Jimenez, Javier

AU - Eliasson, Björn

AU - Hramiak, Irene

AU - Bailey, Timothy

AU - Meneghini, Luigi F

PY - 2019/4/1

Y1 - 2019/4/1

N2 - Introduction: The LIGHTNING study applied conventional and advanced analytic approaches to model, predict, and compare hypoglycemia rates of people with type 2 diabetes (T2DM) on insulin glargine 300 U/ml (Gla-300) with those on first-generation (insulin glargine 100 U/ml [Gla-100]; insulin detemir [IDet]) or second-generation (insulin degludec [IDeg]) basal-insulin (BI) analogs, utilizing a large real-world database. Methods: Data were collected between 1 January 2007 and 31 March 2017 from the Optum Humedica US electronic health records [EHR] database. Patient-treatments, the period during which a patient used a specific BI, were analyzed for patients who switched from a prior BI or those who newly initiated BI therapy. Data were analyzed using two approaches: propensity score matching (PSM) and a predictive modeling approach using machine learning. Results: A total of 831,456 patients with T2DM receiving BI were included from the EHR data set. Following selection, 198,198 patient-treatments were available for predictive modeling. The analysis showed that rates of severe hypoglycemia (using a modified definition) were approximately 50% lower with Gla-300 than with Gla-100 or IDet in insulin-naïve individuals, and 30% lower versus IDet in BI switchers (all p < 0.05). Similar rates of severe hypoglycemia were predicted for Gla-300 and IDeg, regardless of prior insulin experience. Similar results to those observed in the overall cohorts were seen in analyses across subgroups at a particularly high risk of hypoglycemia. PSM (performed on 157,573 patient-treatments) revealed comparable reductions in HbA 1c with Gla-300 versus first- and second-generation BI analogs, alongside lower rates of severe hypoglycemia with Gla-300 versus first-generation BI analogs (p < 0.05) and similar rates versus IDeg in insulin-naïve and BI-switcher cohorts. Conclusions: Based on real-world data, predicted rates of severe hypoglycemia with Gla-300 tended to be lower versus first-generation BI analogs and similar versus IDeg in a wide spectrum of patients with T2DM. Funding: Sanofi, Paris, France.

AB - Introduction: The LIGHTNING study applied conventional and advanced analytic approaches to model, predict, and compare hypoglycemia rates of people with type 2 diabetes (T2DM) on insulin glargine 300 U/ml (Gla-300) with those on first-generation (insulin glargine 100 U/ml [Gla-100]; insulin detemir [IDet]) or second-generation (insulin degludec [IDeg]) basal-insulin (BI) analogs, utilizing a large real-world database. Methods: Data were collected between 1 January 2007 and 31 March 2017 from the Optum Humedica US electronic health records [EHR] database. Patient-treatments, the period during which a patient used a specific BI, were analyzed for patients who switched from a prior BI or those who newly initiated BI therapy. Data were analyzed using two approaches: propensity score matching (PSM) and a predictive modeling approach using machine learning. Results: A total of 831,456 patients with T2DM receiving BI were included from the EHR data set. Following selection, 198,198 patient-treatments were available for predictive modeling. The analysis showed that rates of severe hypoglycemia (using a modified definition) were approximately 50% lower with Gla-300 than with Gla-100 or IDet in insulin-naïve individuals, and 30% lower versus IDet in BI switchers (all p < 0.05). Similar rates of severe hypoglycemia were predicted for Gla-300 and IDeg, regardless of prior insulin experience. Similar results to those observed in the overall cohorts were seen in analyses across subgroups at a particularly high risk of hypoglycemia. PSM (performed on 157,573 patient-treatments) revealed comparable reductions in HbA 1c with Gla-300 versus first- and second-generation BI analogs, alongside lower rates of severe hypoglycemia with Gla-300 versus first-generation BI analogs (p < 0.05) and similar rates versus IDeg in insulin-naïve and BI-switcher cohorts. Conclusions: Based on real-world data, predicted rates of severe hypoglycemia with Gla-300 tended to be lower versus first-generation BI analogs and similar versus IDeg in a wide spectrum of patients with T2DM. Funding: Sanofi, Paris, France.

KW - Basal insulin

KW - Insulin degludec

KW - Insulin detemir

KW - Insulin glargine

KW - Machine learning

KW - Predictive modeling

KW - Real-world evidence

KW - Type 2 diabetes

UR - http://www.scopus.com/inward/record.url?scp=85065769762&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85065769762&partnerID=8YFLogxK

U2 - 10.1007/s13300-019-0568-8

DO - 10.1007/s13300-019-0568-8

M3 - Article

C2 - 30767173

AN - SCOPUS:85065769762

VL - 10

SP - 617

EP - 633

JO - Diabetes Therapy

JF - Diabetes Therapy

SN - 1869-6953

IS - 2

ER -