Alogliptin-Pioglitazone and Insulin Regimen for Inpatient Glycemic Control: A Randomized Continuous Glucose Monitoring Pilot Trial.

OBJECTIVES: Hospitalized patients with type 2 diabetes (T2D) frequently develop hyperglycemia, hypoglycemia, and glycemic variability, which are associated with adverse outcomes outside the intensive care unit. This pilot randomized controlled trial evaluated whether adding a fixed-dose combination (FDC) of alogliptin/pioglitazone to standard basal-bolus insulin improved time in range (TIR), reduced hypoglycemia and/or bolus insulin requirements versus placebo, while generating effect size estimates for a future multicenter trial. METHODS: In this randomized, double-blind, placebo-controlled pilot study, the placebo group (n = 12) received basal-bolus insulin (neutral protamine Hagedorn plus regular insulin) with placebo, whereas the intervention group (IG) (n = 18) received the same insulin regimen plus daily alogliptin/pioglitazone FDC (25/15 mg). Continuous glucose monitoring (FreeStyle Libre 2) assessed TIR (70-180 mg/dL) as the primary endpoint, together with time above range and time below range, during a prespecified 4-d postrandomisation analysis period. RESULTS: The IG achieved significantly higher TIR than placebo (72.44% vs 38.58%; P < 0.001) and lower time above range >250 mg/dL (2.94% vs 28.16%; P < 0.001). Sensor-detected glucose exposure between 54 and 69 mg/dL was numerically higher with the FDC (4.16% vs 0.91%), although not statistically significant (P > 0.05). By day 4, the IG required significantly lower daily bolus insulin doses (P = 0.0003). CONCLUSIONS: In this highly selected inpatient population, adjunctive alogliptin/pioglitazone added to basal-bolus insulin improved continuous glucose monitoring-derived glycaemic stability. Larger adequately powered multicentre trials are needed to confirm safety and efficacy.