Elsevier

Endocrine Practice

Volume 24, Issue 9, September 2018, Pages 805-814
Endocrine Practice

Original Articles
Predictors and Clinical Outcomes of Treatment Intensification in Patients with Type 2 Diabetes Uncontrolled on Basal Insulin in a Real-World Setting

https://doi.org/10.4158/EP-2017-0261Get rights and content

ABSTRACT

Objective: To understand factors associated with intensification of basal insulin therapy and treatment impact on clinical outcomes in patients with type 2 diabetes (T2D).

Methods: In this retrospective, observational study of the Practice Fusion electronic health record database, eligible patients were adults with T2D, ≥1 basal insulin prescription and office visit in the 6 months before a glycated hemoglobin A1c (A1C) test >7.0% (index date), and no other injectable prescriptions in the 12 months before the index date. Patients were categorized to intensifiers with injectables (rapid-acting insulin [RAI], glucagon-like peptide-1 receptor agonist [GLP-1 RA], or other injectables) or nonintensifiers with injectables (including no change, adding an oral antidiabetes drug, or changing basal insulin dose). Principal outcomes were A1C change, hypoglycemia incidence, and change in body weight.

Results: Among 14,653 patients, 2,121 (14.5%) and 12,532 (85.5%) were categorized as intensifiers and nonintensifiers with injectables, respectively. Compared with nonintensifiers, intensifiers were more likely to have an endocrinologist as the prescribing physician (odds ratio [OR], 2.52 [95% confidence interval (CI), 2.16 to 2.94]), hypertension (OR, 1.26 [95% CI, 1.08 to 1.47]), higher baseline A1C (OR, 1.22 [95% CI, 1.17 to 1.26]), obesity (OR, 1.17 [95% CI, 1.01 to 1.36]), and higher body mass index (OR, 1.02 [95% CI, 1.01 to 1.03]). In GLP-1 RA intensifiers, the baseline use of dipeptidyl peptidase-4 inhibitors increased the likelihood of intensification. GLP-1 RA intensifiers had equivalent glycemic control to RAI or other injectables, with a nonsignificantly lower risk of hypoglycemia and reduction in body weight.

Conclusion: Addition of GLP-1 RA to basal insulin may be an effective strategy for overcoming clinical inertia with injectable therapy in patients with T2D.

Abbreviations: A1C = glycated hemoglobin A1c; BMI = body mass index; CI = confidence interval; DCSI = Diabetes Complications Severity Index; DPP-4 = dipeptidyl peptidase-4; EHR = electronic health record; GLP-1 RA = glucagon-like peptide-1 receptor agonist; ICD-9-CM = International Classification of Diseases-Ninth Revision-Clinical Modification; ICD-10-CM = International Classification of Diseases-Tenth Revision-Clinical Modification; OAD = oral antidiabetes drug; OR = odds ratio; RAI = rapid-acting insulin; SGLT-2 = sodium-glucose cotransporter-2; T2D = type 2 diabetes

Section snippets

INTRODUCTION

For patients with type 2 diabetes (T2D), clinical guidelines recommend that when basal insulin is no longer sufficient to achieve glycemic control, additional therapies with different mechanisms of action should be added (1,2). However, clinical inertia still remains a common problem in patients with T2D. One recent systematic review found that in most studies, fewer than 50% of patients underwent treatment intensification within the first year of treatment initiation, and the median time to

Study Design and Data Source

This was a retrospective, observational study of de-identified data from the Practice Fusion ambulatory electronic health record (EHR) platform conducted in patients with T2D and A1C values above 7.0% (53 mmol/mol) while on basal insulin treatment. The Practice Fusion EHR database is currently in use in over 24,000 predominantly single provider or small group practices in all 50 U.S. states and includes over 18 million active patients, representing 4.8% of all ambulatory care in the U.S. The

Patient Disposition and Characteristics

Out of approximately 2.2 million patients with a diagnosis of T2D aged ≥18 years in the Practice Fusion EHR database, 14,653 met all inclusion criteria: 2,121 (14.5%) received intensification with a new injectable (intensifiers with injectables), and 12,532 (85.5%) did not receive intensification with a new injectable (nonintensifiers with injectables) (Fig. 2). Among the intensifiers with injectables, 68.8% (1,459 of 2,121) received an RAI; 16.1% (341 of 2,121) received a GLP-1 RA; and 15.1%

DISCUSSION

This study analyzed EHR data for a large T2D population and assessed the treatment patterns and patient and clinical factors associated with the intensification of therapy as well as clinical and safety outcomes associated with different intensification types. The findings suggest that the majority of patients do not add an injectable therapy to basal insulin within 6 months after failure to control A1C levels. Patients who had visits to an endocrinologist were more likely to receive additional

CONCLUSION

In this real-world population, adding a GLP-1 RA to basal insulin therapy in patients with T2D was as effective in terms of glycemic control as adding an RAI or other injectables. Furthermore, intensification with a GLP-1 RA was associated with a reduction in hypoglycemia events, albeit nonsignificantly, compared with the other subgroups and was the only option of all four groups that produced a reduction in mean body weight. These characteristics, when combined with its relatively easy use,

ACKNOWLEDGMENT

The authors received writing/editorial support in the preparation of this manuscript provided by Yunyu Huang, PhD, of Excerpta Medica, funded by Sanofi.

REFERENCES (19)

There are more references available in the full text version of this article.

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DISCLOSURE

This study was funded by Sanofi. L.K. is an employee of Practice Fusion, under contract with Sanofi. A.S. is a consultant for Practice Fusion and was an employee of Practice Fusion at the time the study was conducted, under contract with Sanofi. W.C., M.Z., and M.D. are employees of Analysis Group, Inc, under contract with Sanofi. T.F. was an employee of Sanofi at the time the study was conducted. W.H. and F.Y. are employees of Sanofi. P.L. is a consultant for Novo Nordisk, Inc, and Sanofi; member of the advisory panel for Novo Nordisk, Inc, and Sanofi; received research support from Amylin Pharmaceuticals, Inc, Eli Lilly and Company, Merck & Co, Novo Nordisk, Inc, Roche, and Sanofi; member of the speakers bureau and author for Amylin Pharmaceuticals, Inc, AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly and Company, Janssen Pharmaceuticals, Inc, Novo Nordisk, Inc, and Sanofi.

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