A multicentre, double‐blind, placebo‐controlled, randomized, parallel comparison, phase 3 trial to evaluate the efficacy and safety of pioglitazone add‐on therapy in type 2 diabetic patients treated with metformin and dapagliflozin

Aim To investigate the efficacy and safety of pioglitazone compared to placebo when added to metformin plus dapagliflozin, a sodium‐glucose cotransporter‐2 (SGLT2) inhibitor, for patients with type 2 diabetes mellitus (T2DM). Materials and Methods In a multicentre study, with a randomized, double‐bl...

Full description

Saved in:
Bibliographic Details
Published in:Diabetes, obesity & metabolism obesity & metabolism, 2024-06, Vol.26 (6), p.2188-2198
Main Authors: Lim, Soo, Lee, Seung‐Hwan, Min, Kyung‐Wan, Lee, Chang Beom, Kim, Sang Yong, Yoo, Hye Jin, Kim, Nan Hee, Kim, Jae Hyeon, Oh, Seungjoon, Won, Jong Chul, Kwon, Hyuk Sang, Kim, Mi Kyung, Park, Jung Hwan, Jeong, In‐Kyung, Kim, Sungrae
Format: Article
Language:English
Subjects:
Adiponectin
Adult
Aged
Antidiabetics
Benzhydryl Compounds - adverse effects
Benzhydryl Compounds - therapeutic use
Blood Glucose - drug effects
Blood Glucose - metabolism
Cholesterol
dapagliflozin
Diabetes
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - drug therapy
Double-Blind Method
Drug Therapy, Combination
Fatty liver
Female
Glucosides - administration & dosage
Glucosides - adverse effects
Glucosides - therapeutic use
Glycated Hemoglobin - analysis
Glycated Hemoglobin - drug effects
Glycated Hemoglobin - metabolism
Hemoglobin
Humans
Hypoglycemia
Hypoglycemic Agents - adverse effects
Hypoglycemic Agents - therapeutic use
Insulin Resistance
Liver
Liver diseases
Male
Metformin
Metformin - adverse effects
Metformin - therapeutic use
Middle Aged
Pioglitazone
Pioglitazone - therapeutic use
Placebos
randomized controlled trial
Republic of Korea
Sodium-glucose cotransporter
Sodium-Glucose Transporter 2 Inhibitors - adverse effects
Sodium-Glucose Transporter 2 Inhibitors - therapeutic use
Thiazolidinediones - adverse effects
Thiazolidinediones - therapeutic use
Treatment Outcome
Waist Circumference - drug effects
Weight
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Aim To investigate the efficacy and safety of pioglitazone compared to placebo when added to metformin plus dapagliflozin, a sodium‐glucose cotransporter‐2 (SGLT2) inhibitor, for patients with type 2 diabetes mellitus (T2DM). Materials and Methods In a multicentre study, with a randomized, double‐blind, placebo‐controlled design, 249 Korean patients with T2DM suboptimally managed on metformin and dapagliflozin were assigned to receive either pioglitazone (15 mg daily) or placebo for 24 weeks, followed by a 24‐week pioglitazone extension. Primary outcomes included changes in glycated haemoglobin (HbA1c), with secondary outcomes assessing insulin resistance, adiponectin levels, lipid profiles, liver enzymes, body weight and waist circumference. Results Pioglitazone administration resulted in a significant reduction in HbA1c levels (from 7.80% ± 0.72% to 7.27% ± 0.82%) compared with placebo (from 7.79% ± 0.76% to 7.69% ± 0.86%, corrected mean difference: −0.42% ± 0.08%; p 
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.15526