PMID- 29377408 OWN - NLM STAT- MEDLINE DCOM- 20181211 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 20 IP - 6 DP - 2018 Jun TI - Two-year trial of intermittent insulin therapy vs metformin for the preservation of beta-cell function after initial short-term intensive insulin induction in early type 2 diabetes. PG - 1399-1407 LID - 10.1111/dom.13236 [doi] AB - AIMS: To test the hypothesis that "induction" intensive insulin therapy (IIT) needs to be followed by "maintenance therapy" to preserve beta-cell function, and to evaluate the impact on beta-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 beta-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; P = .008). Baseline-adjusted HbA1c at 2 years (secondary outcome) was lower in the metformin arm (6.0 +/- 0.2% vs 7.3 +/- 0.2%; P = .0006) (42 +/- 2.2 vs 56 +/- 2.2mmol/mol). At study completion, 66.7% of participants randomized to metformin had an HbA1c concentration