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

NCT05760456 | Unknown Phase 3

• 1 other identifier: V5.0 08.08.2022
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c)

  Hemoglobin A1c

  12 weeks

Secondary Outcomes (2)

• Change from Baseline at Week 12 in Fasting Plasma Glucose

  12 weeks

• Safety assessments

  12 weeks

Study Arms (2)

DIDALA

EXPERIMENTAL

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

Drug: DIDALA hard capsules

METFORMIN

ACTIVE COMPARATOR

Drug: Metformin

Interventions

DIDALA hard capsules DRUG

DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks

DIDALA

Metformin DRUG

Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks

METFORMIN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre of Clinical Pharmacology, Hanoi Medical University: lead

Study Sites (2)

Hanoi Hospital of Traditional Medical

Hanoi, Vietnam

Location

National Hospital of Traditional Medicine

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Centre of Clinical Pharmacology

CONTACT

+84 24 3852 3798; duoclylamsang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 8, 2023
• Study Start: March 15, 2023
• Primary Completion: May 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-02

Locations

VN (2)