NCT05760456

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

An Open-label, Randomized, Parallel-controlled Study to Evaluate the Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	DIDALA hard capsules	DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks
DRUG	Metformin	Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-05-31
• Completion: 2024-08-31
• First posted: 2023-03-08
• Last updated: 2023-03-08

Locations

2 sites across 1 country: Vietnam