drugset / Trial / NCT05760456

Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.

NCT05760456 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, two-group parallel study, comparing before and after treatment within the same group and between the two groups. This study is designed to collect data on the safety and efficacy of a marketed pharmaceutical product (DIDALA) compared with Metformin. The efficacy data of DIDALA will be directly compared with Metformin 1000mg/day monotherapy in this study.

Timeline

Start
2023-03-15
Primary completion
2024-05-31
Completion
2024-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject DIDALA Traditional medicine (herbal / TCM) 2 unknown Oral
Comparator Metformin Small molecule 500 mg —