Tags

Type your tag names separated by a space and hit enter

Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis.
Diabetes Ther. 2020 Jan; 11(1):305-318.DT

Abstract

INTRODUCTION

Basal-bolus (BB) regimens are generally used to intensify basal insulin therapy in patients with type 2 diabetes (T2D) not meeting glycemic targets. However, drawbacks include multiple injection burden and risk of weight gain and hypoglycemia. A once-daily titratable fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi) may provide a simple, well-tolerated, and efficacious alternative. We compared these treatments in a post hoc propensity score matched analysis using randomized trial data.

METHODS

From the LixiLan-L study, 195 patients who had been randomized to iGlarLixi were matched for age, sex, race, T2D duration, baseline body mass index, glycated hemoglobin (HbA1c), fasting plasma glucose, insulin dose, and metformin use to 195 patients who had been randomized to a BB regimen in the GetGoal Duo-2 trial.

RESULTS

At study end, estimated treatment differences for reduction in HbA1c and weight change, and ratio of hypoglycemia events per patient-year (BB vs iGlarLixi) were - 0.28% (standard error 0.08, P = 0.0002), - 1.32 kg (standard error 0.30, P < 0.0001), and 2.85 (P < 0.0001), respectively, all favoring iGlarLixi over BB. Also, proportions of patients reaching individual and composite goals (HbA1c < 7% [< 53 mmol/mol], no weight gain, and no hypoglycemia) were higher in the iGlarLixi compared with the BB treatment group. Gastrointestinal side effects were more common with iGlarLixi.

CONCLUSIONS

In patients with T2D inadequately controlled on basal insulin, iGlarLixi offers an effective alternative to BB regimen for reducing HbA1c, without increased risk of hypoglycemia and weight gain.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT02058160 (LixiLan-L trial); NCT01768559 (GetGoal Duo-2 trial). Plain language summary available for this article.

Authors+Show Affiliations

1st Department of Medicine, Faculty of Medicine, Semmelweis University, Budapest, Hungary. tabak.adam@med.semmelweis-univ.hu.The Frist Clinic, Nashville, TN, USA.San Ignacio University Hospital, Javeriana University, Bogotá, Colombia.BDM Consulting, Inc., Somerset, NJ, USA.Sanofi, Bridgewater, NJ, USA.Sanofi-Aventis, Budapest, Hungary.Servicio de Endocrinología y Nutrición, Instituto de Investigación Biomédica de Málaga (IBIMA), Hospital Universitario Virgen de la Victoria, CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, University of Málaga, Málaga, Spain.Rockwood Clinic, Spokane, WA, USA.St. Josef Hospital, Ruhr-University Bochum, Bochum, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31848983

Citation

Tabák, Ádám G., et al. "Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared With Basal-Bolus Regimen in Patients With Type 2 Diabetes: Propensity Score Matched Analysis." Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders, vol. 11, no. 1, 2020, pp. 305-318.
Tabák ÁG, Anderson J, Aschner P, et al. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020;11(1):305-318.
Tabák, Á. G., Anderson, J., Aschner, P., Liu, M., Saremi, A., Stella, P., Tinahones, F. J., Wysham, C., & Meier, J. J. (2020). Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders, 11(1), 305-318. https://doi.org/10.1007/s13300-019-00735-7
Tabák ÁG, et al. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared With Basal-Bolus Regimen in Patients With Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020;11(1):305-318. PubMed PMID: 31848983.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. AU - Tabák,Ádám G, AU - Anderson,John, AU - Aschner,Pablo, AU - Liu,Minzhi, AU - Saremi,Aramesh, AU - Stella,Peter, AU - Tinahones,Francisco J, AU - Wysham,Carol, AU - Meier,Juris J, Y1 - 2019/12/17/ PY - 2019/10/15/received PY - 2019/12/19/pubmed PY - 2019/12/19/medline PY - 2019/12/19/entrez KW - Hypoglycemia KW - Insulin therapy KW - Type 2 diabetes KW - Weight control KW - iGlarLixi SP - 305 EP - 318 JF - Diabetes therapy : research, treatment and education of diabetes and related disorders JO - Diabetes Ther VL - 11 IS - 1 N2 - INTRODUCTION: Basal-bolus (BB) regimens are generally used to intensify basal insulin therapy in patients with type 2 diabetes (T2D) not meeting glycemic targets. However, drawbacks include multiple injection burden and risk of weight gain and hypoglycemia. A once-daily titratable fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi) may provide a simple, well-tolerated, and efficacious alternative. We compared these treatments in a post hoc propensity score matched analysis using randomized trial data. METHODS: From the LixiLan-L study, 195 patients who had been randomized to iGlarLixi were matched for age, sex, race, T2D duration, baseline body mass index, glycated hemoglobin (HbA1c), fasting plasma glucose, insulin dose, and metformin use to 195 patients who had been randomized to a BB regimen in the GetGoal Duo-2 trial. RESULTS: At study end, estimated treatment differences for reduction in HbA1c and weight change, and ratio of hypoglycemia events per patient-year (BB vs iGlarLixi) were - 0.28% (standard error 0.08, P = 0.0002), - 1.32 kg (standard error 0.30, P < 0.0001), and 2.85 (P < 0.0001), respectively, all favoring iGlarLixi over BB. Also, proportions of patients reaching individual and composite goals (HbA1c < 7% [< 53 mmol/mol], no weight gain, and no hypoglycemia) were higher in the iGlarLixi compared with the BB treatment group. Gastrointestinal side effects were more common with iGlarLixi. CONCLUSIONS: In patients with T2D inadequately controlled on basal insulin, iGlarLixi offers an effective alternative to BB regimen for reducing HbA1c, without increased risk of hypoglycemia and weight gain. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02058160 (LixiLan-L trial); NCT01768559 (GetGoal Duo-2 trial). Plain language summary available for this article. SN - 1869-6953 UR - https://www.unboundmedicine.com/medline/citation/31848983/Efficacy_and_Safety_of_iGlarLixi,_Fixed-Ratio_Combination_of_Insulin_Glargine_and_Lixisenatide,_Compared_with_Basal-Bolus_Regimen_in_Patients_with_Type_2_Diabetes:_Propensity_Score_Matched_Analysis L2 - https://dx.doi.org/10.1007/s13300-019-00735-7 DB - PRIME DP - Unbound Medicine ER -
Try the Free App:
Prime PubMed app for iOS iPhone iPad
Prime PubMed app for Android
Prime PubMed is provided
free to individuals by:
Unbound Medicine.