Alogliptin-Pioglitazone and Insulin Regimen for Inpatient Glycemic Control: A Randomized Continuous Glucose Monitoring Pilot Trial
- 1Department of Internal Medicine, School of Medical Sciences, University of Campinas, Campinas, Brazil
Abstract
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.
Related
- Pediatric Inpatient Continuous Glucose Monitoring: Development and Implementation of a Hospital Policy for Accuracy-Validated Insulin Dosing
- An international position statement on practical approaches for inpatient continuous glucose monitoring, insulin pumps and automated insulin delivery systems in adults
- What are the experiences, perceptions and training needs of inpatient general nursing staff on Continuous Glucose Monitoring?
- Inpatient continuous glucose monitoring halves the risk of hypoglycemia in patients with hyperinsulinism
- Continuous glucose monitoring reveals thyroid feedback-related residual glycemic variability and hypoglycemia during inpatient glucose optimization in euthyroid adults with type 2 diabetes: a CGM-based observational study.
BibTeX
@article{camuto2026alogliptinpioglitazone,
title = {{Alogliptin-Pioglitazone and Insulin Regimen for Inpatient Glycemic Control: A Randomized Continuous Glucose Monitoring Pilot Trial}},
author = {Parson Camuto and Dioze Guadagnini and Heloisa B. Assalin and Daniela O. Magro and Andrey Santos and Mario JA. Saad},
journal = {AACE Endocrinology and Diabetes},
year = {2026},
month = jun,
doi = {10.1016/j.aed.2026.06.010},
url = {https://doi.org/10.1016/j.aed.2026.06.010},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Alogliptin-Pioglitazone and Insulin Regimen for Inpatient Glycemic Control: A Randomized Continuous Glucose Monitoring Pilot Trial
AU - Parson Camuto
AU - Dioze Guadagnini
AU - Heloisa B. Assalin
AU - Daniela O. Magro
AU - Andrey Santos
AU - Mario JA. Saad
PY - 2026
DA - 2026/06/30
JO - AACE Endocrinology and Diabetes
DO - 10.1016/j.aed.2026.06.010
UR - https://doi.org/10.1016/j.aed.2026.06.010
AB - 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.
SN - 3050-9157
ER -