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  • HbA1c target achievement in the elderly: results of the Titration and Optimization trial for initiation of insulin glargine 100 U/mL in patients with type 2 diabetes poorly controlled on oral antidiabetic drugs

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Emerging Technologies, Pharmacology and Therapeutics
HbA1c target achievement in the elderly: results of the Titration and Optimization trial for initiation of insulin glargine 100 U/mL in patients with type 2 diabetes poorly controlled on oral antidiabetic drugs
  1. Andreas Fritsche1,
  2. Helmut Anderten2,
  3. Martin Pfohl MD, PhD3,
  4. Stefan Pscherer4,
  5. Anja Borck5,
  6. Katrin Pegelow5,
  7. Peter Bramlage6,
  8. J Seufert7
  1. 1Medizinische Klinik IV, Universität Tübingen, Tübingen, Germany
  2. 2Gemeinschaftspraxis Anderten-Krok & Partner, Hildesheim, Germany
  3. 3Medizinische Klinik I, Evang. Krankenhaus Bethesda gGmbH, Duisburg, Germany
  4. 4Klinik für Innere Medizin III, Sophien- undHufeland-Klinikum, Weimar, Germany
  5. 5Sanofi-Aventis Deutschland GmbH, Berlin, Germany
  6. 6Institut für Pharmakologie und Präventive Medizin, Cloppenburg, Germany
  7. 7Abteilung Endokrinologie und Diabetologie, Klinik für Innere Medizin II, Medizinische Fakultät, Albert-Ludwig-Universität Freiburg, Freiburg, Germany
  1. Correspondence to Professor Andreas Fritsche; andreas.fritsche{at}med.uni-tuebingen.de

Abstract

Objectives To identify real-world, age-related trends in the use of insulin glargine 100 U/mL (Gla-100) as part of basal-supported oral therapy (BOT).

Research design and methods The prospective, observational Titration and Optimization registry enrolled patients with poorly controlled type 2 diabetes mellitus initiated on Gla-100 BOT. The primary outcome was the proportion of patients with capillary fasting blood glucose (FBG) ≤110 mg/dL on ≥2 occasions and/or who met their individual HbA1c target within 12 months.

Results 2462 patients were analyzed (<65 years: n=1122; 65–74 years: n=771; ≥75 years: n=569). Diabetes duration (6.8, 8.9, and 11.2 years, p<0.0001) and proportion of women (40.7%, 47.9%, and 55.7%, p<0.0001) increased with age. Baseline HbA1c was highest in <65-year-olds (8.6% vs 8.4% and 8.5%, p<0.0001). Gla-100 up-titration until 12 months was highest in <65-year-olds (+11.6 U/day), compared with 65–74 (+10.2 U/day) and ≥75 years (+8.8; p<0.0001) but similar by units per kilogram, as was the decrease in FBG (<65: −64.1 mg/dL; 65–74: −56.1 mg/dL; ≥75: −53.4 mg/dL) and HbA1c (<65: −1.47%; 65–74: −1.31%; ≥75: −1.22%, p<0.0001). At 12 months, 65.9% of participants met the primary endpoint, with no significant difference between age groups. The proportion achieving their individual HbA1c target was lower for <65-year-olds (46.0% vs 54.3% and 54.7%; p<0.02). Symptomatic hypoglycemia incidence was more common in the ≥75-year-old group (3.4% vs 1.4% and 1.4%; p=0.0126).

Conclusions BOT with Gla-100 results in similar improvements of glycemic values with low risk of hypoglycemia across age groups. Given the link between HbA1c and long-term cardiovascular risk, ensuring appropriately stringent target-setting, intensification of basal insulin and making sure hypoglycemia is avoided is of paramount importance.

Trial registration number Database: https://awbdb.bfarm.de; Identifier: 1641; Date of registration: September 23, 2013

  • basal-supported oral therapy
  • glargine
  • age
  • HbA1c target
  • hypoglycaemia

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjdrc-2019-000668

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    Footnotes

    • Contributors Made substantial contributions to conception and design: AF, HA, MP, SP, AB, KP, JS. Made substantial contributions to acquisition of data, or analysis and interpretation of data: AF, HA, MP, SP, AB, KP, PB, JS. Involved in drafting the manuscript: AF, PB. Involved in revising the manuscript critically for important intellectual content: HA, MP, SP, AB, KP, JS. Gave final approval of the version to be published, takes public responsibility and can be held accountable for all aspects of the work: AF, HA, MP, SP, AB, KP, PB, JS.

    • Funding The study was sponsored by Sanofi-Aventis Deutschland GmbH.

    • Competing interests AF: Member of Scientific Advisory Boards of Sanofi, Novo Nordisk, Lilly, and Boehringer. HA: Honorary for consultancy: Sanofi, MSD, Lilli, Boehringer Ingelheim and Pfizer. MP: Member of Scientific Advisory Boards of Boehringer Ingelheim, Eli Lilly, Novo Nordisk and Sanofi. Honorary for talks: Eli Lilly, Novartis, Novo Nordisk and Sanofi. SP: Member of Scientific Advisory Boards of Sanofi. Honorary for talks: Eli Lilly, Novartis, Novo Nordisk, MSD and Sanofi. AB is an employee of Sanofi. KP is an employee of Sanofi. PB: Honorary for consultancy: Sanofi-Aventis, MSD, AstraZeneca, Bristol Myers Squibb (BMS), Boehringer Ingelheim, Novartis and Pfizer. JS received honoraria for talks and/or consultancy and/or research funding from Abbott, Astra Zeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Bristol Myers Squibb (BMS), GI-Dynamics, GlaxoSmithKline (GSK), Intarcia, Ipsen, Janssen, LifeScan, Lilly, Merck Sharp Dohme (MSD), MedScape, Mundipharma, Novartis, Novo Nordisk, Omniamed, Pfizer, Roche, Sanofi Aventis, Servier, Takeda and Ypsomed.

    • Patient consent for publication Obtained.

    • Ethics approval The registry protocol was approved by the relevant local ethics committee, and was carried out in accordance with the Declaration of Helsinki and its amendments.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement All data relevant to the study are included in the article or uploaded as online supplementary information.