Clinical inertia in basal insulin-treated patients with type 2 diabetes - Results from a retrospective database study in Japan (JDDM 43)

PLoS One. 2018 Sep 18;13(9):e0198160. doi: 10.1371/journal.pone.0198160. eCollection 2018.

Abstract

Aims: This retrospective cohort study investigated whether clinical inertia, the failure to intensify treatment when required, exists in Japanese clinical practice, using the CoDiC® database. How and when patients with type 2 diabetes treated with basal insulin received treatment intensification was also described.

Materials and methods: Patients with type 2 diabetes who initiated basal insulin between 2004 and 2011 were eligible for inclusion. Patients with an HbA1c ≥7.0% (≥53.0 mmol/mol) after 180 days of basal insulin titration were eligible for intensification, and their treatment was followed for up to 1.5 years. Endpoints were time to intensification, changes in HbA1c, and insulin dose.

Results: Overall, 2351 patients initiated basal insulin treatment (mean HbA1c 9.4% [79.2 mmol/mol]), and 1279 patients were eligible for treatment intensification (HbA1c ≥7.0% [≥53.0 mmol/mol]) after the 180-day titration period. During the 1.5-year follow-up period (beyond the 180-day titration period), 270 (21%) of these patients received treatment intensification. In patients receiving treatment intensification, mean HbA1c decreased from 8.6 to 8.2% (70.5 to 66.1 mmol/mol) at end of follow-up. Treatment was intensified using bolus insulin in 126 (47%) patients and with premixed insulin in 144 (53%) patients. The estimated probability of intensifying treatment during the 12 months after recording HbA1c ≥7.0% (≥53.0 mmol/mol) was 22.8%, and 27.5% after 17 months. Mean end-of-follow-up daily insulin dose was 35.11 units for basal-bolus compared with 20.70 units for premix therapy.

Conclusions: This study suggests clinical inertia exists in basal insulin-treated patients with type 2 diabetes in Japan. Strategies are needed to increase the number of patients undergoing therapy intensification and to reduce the delay in intensification in Japan.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / epidemiology
  • Dose-Response Relationship, Drug
  • Female
  • Glycated Hemoglobin / analysis
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / pharmacology
  • Hypoglycemic Agents / therapeutic use*
  • Insulin / administration & dosage
  • Insulin / pharmacology
  • Insulin / therapeutic use*
  • Japan / epidemiology
  • Male
  • Middle Aged
  • Retrospective Studies

Substances

  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin
  • hemoglobin A1c protein, human

Grants and funding

This study was funded by Novo Nordisk A/S, Søborg, Denmark. Novo Nordisk A/S provided support in the form of salaries for BBH, BLT, and DT; contracted StatGroup ApS for this analysis (MA is employed by StatGroup ApS and contracted as a consultant by Novo Nordisk A/S for other projects); data analysis; and preparation and submission of the manuscript. Novo Nordisk Pharma Ltd, Tokyo, Japan provided support in the form of a salary for MZ. Medical writing assistance and editorial/submission support was provided by Adele Buss, PhD and Germanicus Hansa- Wilkinson of Watermeadow Medical, an Ashfield Company, part of UDG Healthcare plc, funded by Novo Nordisk A/S.