Work

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

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Objectives Hospitalised patients with type 2 diabetes (T2D) frequently develop hyperglycaemia, hypoglycaemia and glycaemic variability, which are associated with adverse outcomes outside the ICU. This pilot randomised controlled trial evaluated whether adding a fixed-dose combination (FDC) of alogliptin/pioglitazone to standard basal-bolus insulin improved time in range (TIR), reduced hypoglycaemia and/or bolus insulin requirements versus placebo, while generating effect size estimates for a future multicentre trial. Methods In this randomised, 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 (n = 18) received the same insulin regimen plus daily alogliptin/pioglitazone FDC (25/15 mg). Continuous glucose monitoring (CGM; FreeStyle Libre 2) assessed TIR (70–180 mg/dL) as the primary endpoint, together with time above range (TAR) and time below range (TBR), during a prespecified four-day post-randomisation analysis period. Results The intervention group achieved significantly higher TIR than placebo (72.44% vs. 38.58%; p < 0.001) and lower TAR >250 mg/dL (2.94% vs. 28.16%; p < 0.001). Sensor-detected glucose exposure between 54–69 mg/dL was numerically higher with the FDC (4.16% vs. 0.91%), although not statistically significant (p > 0.05). By day 4, the intervention group 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 CGM-derived glycaemic stability. Larger adequately powered multicentre trials are needed to confirm safety and efficacy.

Source: AACE Endocrinology and Diabetes

DOI: 10.1016/j.aed.2026.06.010

Authors: Parson Camuto, Dioze Guadagnini, Heloisa B. Assalin, Daniela O. Magro, Andrey Santos, Mario JA. Saad

Institution: Universidade Estadual de Campinas (UNICAMP)

Language: English

Topic: Hyperglycemia and glycemic control in critically ill and hospitalized patients

Subfield: Endocrinology, Diabetes and Metabolism

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Funders: Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico