Original ArticleA Stepwise Approach to Insulin Therapy in Patients with Type 2 Diabetes Mellitus and Basal Insulin Treatment Failure
Section snippets
INTRODUCTION
The American Diabetes Association (ADA) recommends a glycated hemoglobin A1c (A1C) target less than 7.0% (1), which, unfortunately, fewer than 60% of diabetic patients achieve (2, 3). Owing to the progressive nature of type 2 diabetes mellitus, insulin therapy is often required to achieve glycemic control (4, 5). When lifestyle modifications and treatment with metformin with or without other oral antidiabetic drugs (OADs) have failed to achieve normoglycemia, timely initiation of singledose
RESULTS
Patient Disposition, Demographics, and Characteristics at Randomization
A total of 1232 patients were screened, of which 785 (64%) participated in the 14-week run-in period and were treated with insulin glargine (Fig. 2). Among these, 288 achieved an A1C concentration of 7.0% or less at the end of the run-in period and were not eligible for randomization. A total of 154 of 785 patients (20%) withdrew during the run-in period; withdrawal reasons are listed in the Figure 2 legend. The remaining
Glycemic Control
Treatment with insulin glargine during the 14-week run-in phase reduced mean A1C levels from greater than 10.0% at screening to ~ 8.0%, with 37% of those starting the run-in and 46% of those completing the run-in achieving the target A1C level of 7.0% or less. The final glargine dosage was the same (0.55 units/kg) in those who achieved the target A1C level at the end of the run-in period and in those who did not. At study endpoint (week 24), participants in the 1 ×, 2 ×, and 3 × groups were taking
DISCUSSION
Nearly half of the patients who finished the run-in phase achieved the A1C target level of 7.0% or less after 14 weeks of treatment with insulin glargine. In patients not achieving goal A1C levels with basal insulin, intensification of insulin therapy by adding prandial insulin is a logical next step to minimize postprandial glycemic excursions (6). After the 14-week run-in period, during which insulin glargine was actively titrated to achieve fasting goals, insulin glulisine was added for
CONCLUSION
The clinical evidence in support of initiating prandial insulin via progressive increases in the number of preprandial injections as necessary, as an alternative treatment algorithm, may simplify intensification of insulin therapy, improve the willingness of physicians and patients to aggressively manage diabetes, and significantly improve glycemic control for patients with type 2 diabetes. Further studies are needed to prospectively evaluate the proportion of patients requiring 1, 2, or 3
DISCLOSURE
The authors have no multiplicity of interest to disclose.
ACKNOWLEDGMENT
Clinical Trial Registration: NCT00135083. Study and editorial support funded by sanofi-aventis U.S.
REFERENCES (20)
New strategies for basal insulin treatment in type 2 diabetes mellitus
Clin Ther
(2004)Standards of medical care in diabetes—2010.
Diabetes Care.
(2010)- et al.
Achievement of American Diabetes Association clinical practice recommendations among U.S. adults with diabetes, 1999-2002: The National Health and Nutrition Examination Survey
Diabetes Care
(2006) - et al.
Is glycemic control improving in U.S. adults?
Diabetes Care
(2008) - et al.
U.K. Prospective Diabetes Study Group. Sulfonylurea inadequacy: Efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57)
Diabetes Care
(2002) A timely transition to insulin: Identifying type 2 diabetes patients failing oral therapy
Formulary
(2005)- et al.
American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes
Diabetes Care
(2009) - et al.
Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: Variations with increasing levels of HbA(1c)
Diabetes Care
(2003) Intensive insulin therapy in type 1 diabetes mellitus.
- et al.
Narrative review: A rational approach to starting insulin therapy
Ann Intern Med
(2006)
Cited by (89)
Macrophages as a therapeutic target to promote diabetic wound healing
2022, Molecular TherapyMacrophage polarization and diabetic wound healing
2021, Translational ResearchEvidence-based recommendations for insulin intensification strategies after basal insulin in type 2 diabetes
2017, Diabetes and Metabolic Syndrome: Clinical Research and ReviewsBehaviours, thoughts and perceptions around mealtime insulin usage and wastage among people with type 1 and type 2 diabetes mellitus: A cross-sectional survey study
2017, Diabetes Research and Clinical PracticeTitration of basal insulin or immediate addition of rapid acting insulin in patients not at target using basal insulin supported oral antidiabetic treatment – A prospective observational study in 2202 patients
2017, Diabetes and Metabolic Syndrome: Clinical Research and Reviews