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

NCT05760456 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-03-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Centre of Clinical Pharmacology, Hanoi Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Vietnam

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05760456 on ClinicalTrials.gov