Randomized, Double-blind, Phase III Trial of Lobeglitazone Add-on to Metformin in Type 2 Diabetes (SENSITIZE INDIA).
Humans
Diabetes Mellitus, Type 2
/ drug therapy
Metformin
/ therapeutic use
Hypoglycemic Agents
/ therapeutic use
Male
Middle Aged
Double-Blind Method
Female
Thiazolidinediones
/ therapeutic use
Glycated Hemoglobin
/ analysis
Drug Therapy, Combination
India
Pioglitazone
/ therapeutic use
Blood Glucose
/ analysis
Adult
Treatment Outcome
Aged
Pyrimidines
Journal
The Journal of the Association of Physicians of India
ISSN: 0004-5772
Titre abrégé: J Assoc Physicians India
Pays: India
ID NLM: 7505585
Informations de publication
Date de publication:
Jan 2024
Jan 2024
Historique:
medline:
13
5
2024
pubmed:
13
5
2024
entrez:
13
5
2024
Statut:
ppublish
Résumé
The efficacy and safety of lobeglitazone sulfate has been reported only in the Korean population, and no study has been conducted in India. 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. 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] ( 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.
Sections du résumé
BACKGROUND
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 AND METHODS
METHODS
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
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] (
CONCLUSION
CONCLUSIONS
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.
Identifiants
pubmed: 38736072
doi: 10.59556/japi.71.0445
doi:
Substances chimiques
Metformin
9100L32L2N
Hypoglycemic Agents
0
lobeglitazone
MY89F08K5D
Thiazolidinediones
0
Glycated Hemoglobin
0
Pioglitazone
X4OV71U42S
Blood Glucose
0
Pyrimidines
0
Types de publication
Journal Article
Randomized Controlled Trial
Clinical Trial, Phase III
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
32-42Informations de copyright
© Journal of the Association of Physicians of India 2024.