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Meta-Analysis
. 2017 Feb;96(5):e6022.
doi: 10.1097/MD.0000000000006022.

Impact of patient and treatment characteristics on glycemic control and hypoglycemia in patients with type 2 diabetes initiated to insulin glargine or NPH: A post hoc, pooled, patient-level analysis of 6 randomized controlled trials

Francesca Porcellati  1 , Jay Lin, Paola Lucidi, Geremia B Bolli, Carmine G Fanelli
Affiliations
Meta-Analysis

Impact of patient and treatment characteristics on glycemic control and hypoglycemia in patients with type 2 diabetes initiated to insulin glargine or NPH: A post hoc, pooled, patient-level analysis of 6 randomized controlled trials

Francesca Porcellati et al. Medicine (Baltimore). 2017 Feb.

Abstract

Background: The goal of this post hoc analysis was to determine key patient and treatment-related factors impacting glycosylated hemoglobin (A1C) and hypoglycemia in patients with uncontrolled type 2 diabetes who were initiated to basal insulin (neutral protamine Hagedorn [NPH] or glargine).

Methods: Using individual patient-level data pooled from 6 treat-to-target trials, 2600 patients with type 2 diabetes on oral antidiabetic agents initiated to insulin glargine or NPH and treated for 24 to 36 weeks were analyzed.

Results: Both treatments led to significant reduction in A1C levels compared with baseline, with no differences between treatment groups (mean ± standard deviation; glargine: -1.32 ± 1.2% vs NPH: -1.26 ± 1.2%; P = 0.15), with greater reduction in the BMI ≥30 kg/m group than in the BMI <30 kg/m group. Glargine reduced A1C significantly more than NPH in the BMI <30 kg/m group (-1.30 ± 1.18% vs -1.14 ± 1.22, respectively; P = 0.008), but not in the BMI ≥ 30 kg/m group (-1.37 ± 1.19 vs -1.48 ± 1.22, respectively; P = 0.18). Similar proportions of patients achieved A1C target of <7% (glargine 30.6%, NPH 29.1%; P = 0.39). Incidence of severe and severe nocturnal hypoglycemia was significantly lower in glargine versus NPH-treated patients (2.0% vs 3.9%; P = 0.04, and 0.7% vs 2.1%; P = 0.002, respectively), and occurred primarily in the BMI <30 kg/m group.

Conclusions: Initiation of basal insulin is highly effective in lowering A1C after oral antidiabetic agent failure. Glargine decreases A1C more than NPH in nonobese patients, and reduces the risk for severe and severe nocturnal hypoglycemia versus NPH both in obese and nonobese patients, but more so in nonobese patients. Thus, it is the nonobese patients who may benefit more from initiation of basal insulin as glargine than NPH.

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Conflict of interest statement

Authors' contributions: JL also contributed to data collection for this manuscript. FP, PL, GBB, and CGF have no conflicts to disclose with regard to this post-hoc analysis. JL is a consultant to Sanofi. All authors contributed to the conduct, data analysis/interpretation, and writing of this manuscript. The authors report no conflicts of interest.

Figures

Figure 1
Figure 1
A1C levels at baseline and endpoint by treatment group (A), BMI group (B), and treatment/BMI (C). A1C, glycosylated hemoglobin; BMI, body mass index.
Figure 2
Figure 2
Incidence and events per patient-year of severe (A) and severe nocturnal (B) hypoglycemia by treatment group and BMI. BMI, body mass index.
Figure 3
Figure 3
Meta-analysis of studies: A1C change by treatment. A1C, glycosylated hemoglobin.
See this image and copyright information in PMC

References

    1. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012;35:1364–79. - PMC - PubMed
    1. American Diabetes Association Standards of medical care in diabetes: 2015: 7 approaches to glycemic treatment 2015;38(suppl 1):S41–8. - PubMed
    1. Gerstein HC, Bosch J, Dagenais GR, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012;367:319–28. - PubMed
    1. Bolli GB, Lucidi P, Porcellati F, et al. Pivotal role of timely basal insulin replacement after metformin failure in sustaining long-term blood glucose control at a target in type 2 diabetes. Diabetes Care 2011;34(suppl 2):S220–4. - PMC - PubMed
    1. Lucidi P, Porcellati F, Rossetti P, et al. Pharmacokinetics and pharmacodynamics of therapeutic doses of basal insulins NPH, glargine, and detemir after 1 week of daily administration at bedtime in type 2 diabetic subjects: a randomized cross-over study. Diabetes Care 2011;34:1312–4. - PMC - PubMed

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