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

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University
• Treatments: Metformin

Criteria

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.