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

C

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)

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

Trial contacts and locations

2

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Central trial contact

Centre of Clinical Pharmacology

Data sourced from clinicaltrials.gov

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