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Diabetes Obes Metab. 2019 Feb 5. doi: 10.1111/dom.13653. [Epub ahead of print]

When Basal Insulin is Not Enough: A Dose Response Relationship Between Insulin Glargine 100 Units/mL (U100) and Glycemic Control.

Author information

1
Emory University School of Medicine, Atlanta, GA, USA.
2
Abington Family Medicine, Jenkintown, PA, USA.
3
Sanofi US, Inc., Bridgewater, NJ, USA.
4
Xinyi, Inc., Bridgewater, NJ, USA.
5
University Medical Group, Augusta, GA, USA.

Abstract

AIMS:

One option recommended by treatment guidelines for the management of patients with uncontrolled type 2 diabetes and post-prandial excursions is adding prandial insulin when basal insulin dose is >0.5 IU/kg/day. This recommendation is based on expert opinion, with limited clinical evidence for this threshold dose. In this post-hoc analysis, we construct a clinical-response curve for basal insulin, assessing the impact of increasing doses on glycemic measures, body weight, and hypoglycemia.

RESEARCH DESIGN AND METHODS:

We included data from prospective, randomized controlled treat-to-target trials of ≥24 weeks duration conducted between 1997 and 2007 in patients with type 2 diabetes, uncontrolled on metformin and sulfonylurea, and treated with insulin glargine U100, who had at least six fasting plasma glucose (FPG) measurements. The impact of insulin dose on A1C values, FPG, hypoglycemia incidence (<70 mg/dL, 3.9 mmol/L), and body weight was analyzed. 458 patients from three eligible trials were included.

RESULTS:

The observed relationship between higher basal insulin doses and glycemic control was non-linear, with increasing insulin dose leading to smaller reductions of FPG and A1C for doses >0.3 IU/kg/d, with a plateauing of effect at 0.5 IU/kg/d. Total daily dose of insulin >0.5 IU/kg/d resulted in greater weight gain, but without higher rates of hypoglycemia compared to insulin doses ≤0.5 IU/kg/d.

CONCLUSIONS:

This analysis indicates that basal insulin doses >0.5 IU/kg/d have diminishing additional impact on improving glycemic measures, with the disadvantage of additional weight gain. Clinicians should consider antihyperglycemic treatment intensification at doses approaching 0.5 IU/kg/d. This article is protected by copyright. All rights reserved.

KEYWORDS:

A1C; Type 2 diabetes; basal insulin; glargine; postprandial

PMID:
30724009
DOI:
10.1111/dom.13653

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