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
Primary result · HbA1cResult — go to the resultCorrected mean difference −0.42 %Authors' conclusion
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.
Study context
- Population
- Korean patients with T2D suboptimally managed on metformin and dapagliflozin
- Participants
- 249 patients
- Comparison
- Pioglitazone 15 mg daily vs placebo added to metformin plus dapagliflozin
- Primary endpoint
- Change in HbA1c
- Follow-up
- 24 weeks
Methodological detailsmulticentre, double-blind, placebo-controlled, 24-week pioglitazone extension
- Multicentre
- Double-blind
- Placebo-controlled
- 24-week pioglitazone extension
Primary result
HbA1c
Corrected mean difference
−0.42 %
P < 0.01
By group
As reported in the abstract
Secondary outcomes
- Pioglitazone enhanced insulin sensitivity, increased adiponectin, raised HDL-C and reduced liver enzymes, improving NAFLD liver fat score
Safety
Events
| Outcome | Pioglitazone | Placebo |
|---|---|---|
| Serious adverse events, weight and waist circumference | 0 | 0 |
Serious adverse events, weight and waist circumference
- No serious adverse events in either group
- Pioglitazone modestly but significantly associated with weight gain and increased waist circumference
Original publication
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. Published 29 February 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →