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- Title
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.
- 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
- Abstract
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 < 0.01) at 24 weeks. Additional benefits from pioglitazone treatment included enhanced insulin sensitivity, increased adiponectin levels, raised high‐density lipoprotein cholesterol levels and reduced liver enzyme levels, resulting in improvement in nonalcoholic fatty liver disease liver fat score. Despite no serious adverse events in either group, pioglitazone therapy was modestly but significantly associated with weight gain and increased waist circumference. Conclusions: Adjunctive pioglitazone treatment in T2DM inadequately controlled with metformin and dapagliflozin demonstrates considerable glycaemic improvement, metabolic benefits, and a low risk of hypoglycaemia. These advantages must be weighed against the potential for weight gain and increased waist circumference.
- Subjects
SODIUM-glucose cotransporters; CLINICAL trials; DAPAGLIFLOZIN; NON-alcoholic fatty liver disease; PIOGLITAZONE; TYPE 2 diabetes
- Publication
Diabetes, Obesity & Metabolism, 2024, Vol 26, Issue 6, p2188
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.15526