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- Title
Two‐year trial of intermittent insulin therapy vs metformin for the preservation of β‐cell function after initial short‐term intensive insulin induction in early type 2 diabetes.
- Authors
Choi, Haysook; Ye, Chang; Kramer, Caroline K.; Retnakaran, Ravi; Zinman, Bernard
- Abstract
Aims: To test the hypothesis that “induction” intensive insulin therapy (IIT) needs to be followed by “maintenance therapy” to preserve β‐cell function, and to evaluate the impact on β‐cell function over 2 years of two approaches to maintenance therapy: intermittent short‐term IIT every 3 months vs daily metformin. Materials and methods: In this trial, 24 adults with a mean type 2 diabetes mellitus (T2DM) duration of 2.0 ± 1.7 years and glycated haemoglobin (HbA1c) levels 6.4 ± 0.1% (46 ± 1.1mmol/mol) were randomized to 3 weeks of induction IIT (glargine, lispro) followed by either repeat IIT for up to 2 weeks every 3 months or daily metformin. Participants underwent serial assessment of β‐cell function using the Insulin Secretion‐Sensitivity Index‐2 (ISSI‐2) on an oral glucose tolerance test every 3 months. Results: The primary outcome of baseline‐adjusted ISSI‐2 at 2 years was higher in the metformin arm compared with intermittent IIT (245.0 ± 31.7 vs 142.2 ± 18.4; <italic>P</italic> = .008). Baseline‐adjusted HbA1c at 2 years (secondary outcome) was lower in the metformin arm (6.0 ± 0.2% vs 7.3 ± 0.2%; <italic>P</italic> = .0006) (42 ± 2.2 vs 56 ± 2.2mmol/mol). At study completion, 66.7% of participants randomized to metformin had an HbA1c concentration ≤ 6.0% (≤42mmol/mol), compared with 8.3% of those on intermittent IIT (<italic>P</italic> = .009). There were no differences in insulin sensitivity. Conclusion: After induction IIT, metformin was superior to intermittent IIT for maintaining β‐cell function and glycaemic control over 2 years. The strategy of induction and maintenance therapy to preserve β‐cell function warrants exploration in early T2DM.
- Subjects
INSULIN therapy effectiveness; METFORMIN; TYPE 2 diabetes treatment; INSULIN therapy administration; TYPE 2 diabetes diagnosis
- Publication
Diabetes, Obesity & Metabolism, 2018, Vol 20, Issue 6, p1399
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.13236