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

Phase 3

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: DIDALA hard capsules; Drug: Metformin

• Registration Number: NCT05760456
• Lead Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-30
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-03-08
• Last Update Posted: 2023-03-08
• Study Start: 2023-03-15
• Primary Completion: 2024-05-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• 18 years or older at the time of enrollment in the study.
• Diagnosed with type 2 diabetes according to the Guidelines for the diagnosis of type 2 diabetes of the Ministry of Health (2011).
• Fasting blood glucose ≤ 10.0 mmol/L.
• No previous treatment with metformin or other antidiabetic drugs.
• Ability and willingness to provide written informed consent and comply with the protocol's requirements.
• Subject who, in the judgment of the Investigator, is likely to be compliant or cooperative during the study.

Exclusion Criteria

• The patient has been diagnosed with diabetes and has been previously treated with metformin or other antidiabetic agents.
• Patients with indications for insulin therapy or combination therapy of two or more drugs according to the guidelines for diagnosis and treatment of type 2 diabetes of the Ministry of Health.
• Pregnancy or lactation.
• Patients with contraindications to Metformin include severe liver and/or kidney disease, congestive heart failure, cardiovascular collapse, acute myocardial infarction, severe infection, and sepsis.
• Patients with conditions and circumstances that, in the investigator's opinion, are difficult to ensure adherence to study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIDALA	DIDALA hard capsules	DIDALA is a herbal medicine, produced from dried mulberry leaves. The drug has been approved by the Drug Administration of Vietnam.
METFORMIN	Metformin	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c)	12 weeks	Hemoglobin A1c

Secondary Outcome Measures

Name	Time	Method
Change from Baseline at Week 12 in Fasting Plasma Glucose	12 weeks	Fasting Plasma Glucose
Safety assessments	12 weeks	Safety will be assessed based on the frequency of occurrence of adverse events (AEs) of concern including hypoglycaemic events, clinically significant changes in laboratory parameters (complete blood count, blood biochemistry test), and vital signs during the study period.

Trial Locations

Locations (2)

National Hospital of Traditional Medicine; 🇻🇳 Hanoi, Vietnam

Hanoi Hospital of Traditional Medical; 🇻🇳 Hanoi, Vietnam