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

Type 2 Diabetes Clinical Trial

Official title:

An Open-label, Randomized, Parallel-controlled Study to Evaluate the Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05760456
• Other study ID #: V5.0 08.08.2022
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 15, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2023
• Source: Centre of Clinical Pharmacology, Hanoi Medical University
• Contact: Centre of Clinical Pharmacology
• Phone: +84 24 3852 3798
• Email: duoclylamsang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• DIDALA hard capsules
DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks
• Metformin
Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks

Locations

Country	Name	City	State
Vietnam	Hanoi Hospital of Traditional Medical	Hanoi
Vietnam	National Hospital of Traditional Medicine	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Clinical Pharmacology, Hanoi Medical University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c)	Hemoglobin A1c	12 weeks
Secondary	Change from Baseline at Week 12 in Fasting Plasma Glucose	Fasting Plasma Glucose	12 weeks
Secondary	Safety assessments	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.	12 weeks