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

Centre of Clinical Pharmacology, Hanoi Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin; Drug: DIDALA hard capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT05760456

V5.0 08.08.2022

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

DIDALA

Experimental group

Description:

DIDALA is a herbal medicine, produced from dried mulberry leaves. The drug has been approved by the Drug Administration of Vietnam.

Treatment:

Drug: DIDALA hard capsules

METFORMIN

Active Comparator group

Treatment:

Drug: Metformin