Randomized, Double-blind, Phase III Trial of Lobeglitazone Add-on to Metformin in Type 2 Diabetes (SENSITIZE INDIA).
J Assoc Physicians India
; 72(1): 32-42, 2024 Jan.
Article
em En
| MEDLINE
| ID: mdl-38736072
ABSTRACT
BACKGROUND:
The efficacy and safety of lobeglitazone sulfate has been reported only in the Korean population, and no study has been conducted in India. MATERIALS ANDMETHODS:
In this 16-week randomized, double-blind, and multicenter study, the efficacy and safety of lobeglitazone sulfate 0.5 mg were evaluated with pioglitazone 15 mg. Type 2 diabetes mellitus (T2DM) patients with ≥7.5% glycated hemoglobin (HbA1c) ≤10.5% and on stable metformin dose were assigned to both treatment arms. The primary outcome was a mean change in HbA1c. Safety assessments included adverse events (AE), home-based glucose monitoring, vital parameters, electrocardiogram (ECG), and laboratory assessments.RESULTS:
A total of 328 subjects were randomized equally in two groups. A statistically significant reduction in HbA1c at week 16 in the lobeglitazone group with the least square (LS) mean change 1.01 [standard error (SE) 0.09] (p < 0.0001) was seen. The LS mean difference between the two groups was 0.05 (SE 0.12) [95% confidence interval (CI) -0.18, 0.27], which was statistically significant (p = 0.0013). Statistically significant reductions were also observed in fasting and postprandial glucose. Treatment-emergent Aes (TEAE) were comparable between both groups.CONCLUSION:
Lobeglitazone 0.5 mg once daily was found to be efficacious and safe in the treatment of T2DM in the Indian population. Lobeglitazone significantly improved glycemic parameters and was noninferior to pioglitazone; hence, it could be a promising insulin sensitizer in T2DM management in India.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Hemoglobinas Glicadas
/
Tiazolidinedionas
/
Diabetes Mellitus Tipo 2
/
Quimioterapia Combinada
/
Pioglitazona
/
Hipoglicemiantes
/
Metformina
Limite:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
Asia
Idioma:
En
Revista:
J Assoc Physicians India
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Índia