Efficacy and Safety of Pioglitazone Add‐On in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials

ABSTRACT Background Type 2 diabetes mellitus (T2DM) accounts for over 90% of diabetes cases worldwide. Pioglitazone, a thiazolidinedione, enhances insulin sensitivity by activating PPAR‐γ. Evidence on its efficacy and safety as an add‐on to metformin and SGLT2 inhibitors in inadequately controlled T...

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Main Authors: Ubaid Khan, Zuhair Majeed, Muhammad Haris Khan, Ahmed Bostamy Elsnhory, Ahmed Mazen Amin, Anum Nawaz, Ahmed Raza, Hafiz Muhammad Waqas Siddque, Mustafa Turkmani, Mohamed Abuelazm
Format: Article
Language:English
Published: Wiley 2025-05-01
Series:Endocrinology, Diabetes & Metabolism
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Online Access:https://doi.org/10.1002/edm2.70061
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author Ubaid Khan
Zuhair Majeed
Muhammad Haris Khan
Ahmed Bostamy Elsnhory
Ahmed Mazen Amin
Anum Nawaz
Ahmed Raza
Hafiz Muhammad Waqas Siddque
Mustafa Turkmani
Mohamed Abuelazm
author_facet Ubaid Khan
Zuhair Majeed
Muhammad Haris Khan
Ahmed Bostamy Elsnhory
Ahmed Mazen Amin
Anum Nawaz
Ahmed Raza
Hafiz Muhammad Waqas Siddque
Mustafa Turkmani
Mohamed Abuelazm
author_sort Ubaid Khan
collection DOAJ
description ABSTRACT Background Type 2 diabetes mellitus (T2DM) accounts for over 90% of diabetes cases worldwide. Pioglitazone, a thiazolidinedione, enhances insulin sensitivity by activating PPAR‐γ. Evidence on its efficacy and safety as an add‐on to metformin and SGLT2 inhibitors in inadequately controlled T2DM is limited. This systematic review and meta‐analysis evaluates pioglitazone's role as a third‐line therapy for improving glycaemic control in addition to metformin and Dapagliflozin. Methodology We conducted comprehensive searches across PubMed, CENTRAL, WOS, Scopus and EMBASE until December 2024. Pooled data were reported using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, along with a 95% confidence interval (CI). This systematic review and meta‐analysis is registered with PROSPERO ID: CRD42024612005. Results We included three RCTs with 885 patients. Pioglitazone add‐on therapy significantly reduced HbA1c levels (MD: −0.41; 95% CI: −0.54 to −0.27, p = < 0.00001, I2 = 0%), fasting blood glucose (MD: −11.91; 95% CI: −16.34 to −7.48, p = < 0.00001, I2 = 0%), Homeostatic Model Assessment for Insulin Resistance (HOMA‐IR) (MD: −0.65; 95% CI: −1.05 to −0.25, p = 0.001, I2 = 4.89%), increased the rate of achieving HbA1c < 7% (RR: 2.09; 95% CI: 1.66 to 2.64, p = < 0.00001, I2 = 0%), and HbA1c < 6.5% (RR: 2.19; 95% CI: 1.36 to 3.53, p = 0.001, I2 = 0%). However, there was no difference regarding Homeostasis model assessment of β‐cell function (HOMA‐β) between the two groups (MD: 2.73; 95% CI: −5.24 to 10.70, p = 0.5, I2 = 27.53%). Conclusion Pioglitazone add‐on therapy significantly improved glycaemic control by reducing HbA1c, fasting blood glucose and HOMA‐IR while increasing the likelihood of achieving HbA1c targets. However, no significant difference was observed in HOMA‐β between groups. These findings suggest the potential benefit of pioglitazone in enhancing glycaemic outcomes in diabetes management.
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spelling doaj-art-5f62ce79c8ff47c6b13db06768b77a9a2025-08-20T03:05:30ZengWileyEndocrinology, Diabetes & Metabolism2398-92382025-05-0183n/an/a10.1002/edm2.70061Efficacy and Safety of Pioglitazone Add‐On in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin: A Systematic Review and Meta‐Analysis of Randomised Controlled TrialsUbaid Khan0Zuhair Majeed1Muhammad Haris Khan2Ahmed Bostamy Elsnhory3Ahmed Mazen Amin4Anum Nawaz5Ahmed Raza6Hafiz Muhammad Waqas Siddque7Mustafa Turkmani8Mohamed Abuelazm9Division of Cardiology University of Maryland School of Medicine Baltimore Maryland USADepartment of Medicine King Edward Medical University Lahore PakistanDepartment of Medicine Saidu Medical College Swat PakistanEmergency Medicine Department Al‐Bank Al‐Ahly Hospital Cairo EgyptFaculty of Medicine Mansoura University Mansoura EgyptDepartment of Radiology Pakistan Atomic Energy Commission Hospital Islamabad PakistanDepartment of Medicine Services Institute of Medical Sciences Lahore PakistanDepartment of Medicine MedStar Health Georgetown University (Baltimore) Program Baltimore Maryland USAFaculty of Medicine Michigan State University East Lansing Michigan USAFaculty of Medicine Tanta University Tanta EgyptABSTRACT Background Type 2 diabetes mellitus (T2DM) accounts for over 90% of diabetes cases worldwide. Pioglitazone, a thiazolidinedione, enhances insulin sensitivity by activating PPAR‐γ. Evidence on its efficacy and safety as an add‐on to metformin and SGLT2 inhibitors in inadequately controlled T2DM is limited. This systematic review and meta‐analysis evaluates pioglitazone's role as a third‐line therapy for improving glycaemic control in addition to metformin and Dapagliflozin. Methodology We conducted comprehensive searches across PubMed, CENTRAL, WOS, Scopus and EMBASE until December 2024. Pooled data were reported using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, along with a 95% confidence interval (CI). This systematic review and meta‐analysis is registered with PROSPERO ID: CRD42024612005. Results We included three RCTs with 885 patients. Pioglitazone add‐on therapy significantly reduced HbA1c levels (MD: −0.41; 95% CI: −0.54 to −0.27, p = < 0.00001, I2 = 0%), fasting blood glucose (MD: −11.91; 95% CI: −16.34 to −7.48, p = < 0.00001, I2 = 0%), Homeostatic Model Assessment for Insulin Resistance (HOMA‐IR) (MD: −0.65; 95% CI: −1.05 to −0.25, p = 0.001, I2 = 4.89%), increased the rate of achieving HbA1c < 7% (RR: 2.09; 95% CI: 1.66 to 2.64, p = < 0.00001, I2 = 0%), and HbA1c < 6.5% (RR: 2.19; 95% CI: 1.36 to 3.53, p = 0.001, I2 = 0%). However, there was no difference regarding Homeostasis model assessment of β‐cell function (HOMA‐β) between the two groups (MD: 2.73; 95% CI: −5.24 to 10.70, p = 0.5, I2 = 27.53%). Conclusion Pioglitazone add‐on therapy significantly improved glycaemic control by reducing HbA1c, fasting blood glucose and HOMA‐IR while increasing the likelihood of achieving HbA1c targets. However, no significant difference was observed in HOMA‐β between groups. These findings suggest the potential benefit of pioglitazone in enhancing glycaemic outcomes in diabetes management.https://doi.org/10.1002/edm2.70061dapagliflozinmetforminpioglitazonereviewtype 2 diabetes mellitus
spellingShingle Ubaid Khan
Zuhair Majeed
Muhammad Haris Khan
Ahmed Bostamy Elsnhory
Ahmed Mazen Amin
Anum Nawaz
Ahmed Raza
Hafiz Muhammad Waqas Siddque
Mustafa Turkmani
Mohamed Abuelazm
Efficacy and Safety of Pioglitazone Add‐On in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials
Endocrinology, Diabetes & Metabolism
dapagliflozin
metformin
pioglitazone
review
type 2 diabetes mellitus
title Efficacy and Safety of Pioglitazone Add‐On in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials
title_full Efficacy and Safety of Pioglitazone Add‐On in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials
title_fullStr Efficacy and Safety of Pioglitazone Add‐On in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials
title_full_unstemmed Efficacy and Safety of Pioglitazone Add‐On in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials
title_short Efficacy and Safety of Pioglitazone Add‐On in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials
title_sort efficacy and safety of pioglitazone add on in patients with type 2 diabetes mellitus inadequately controlled with metformin and dapagliflozin a systematic review and meta analysis of randomised controlled trials
topic dapagliflozin
metformin
pioglitazone
review
type 2 diabetes mellitus
url https://doi.org/10.1002/edm2.70061
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