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.
Diabetes Obes Metab
; 26(6): 2188-2198, 2024 Jun.
Article
in En
| MEDLINE
| ID: mdl-38425186
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 ANDMETHODS:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Benzhydryl Compounds
/
Glycated Hemoglobin
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Diabetes Mellitus, Type 2
/
Drug Therapy, Combination
/
Pioglitazone
/
Glucosides
/
Hypoglycemic Agents
/
Metformin
Country/Region as subject:
Asia
Language:
En
Journal:
Diabetes Obes Metab
/
Diabetes obes. metab
/
Diabetes, obesity & metabolism
Journal subject:
ENDOCRINOLOGIA
/
METABOLISMO
Year:
2024
Document type:
Article
Affiliation country:
South Korea
Country of publication:
United kingdom