Back to resultsSafety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.
Primary Purpose
Type 2 Diabetes
Status
Not yet recruiting
Phase
Phase 3
Locations
Vietnam
Study Type
Interventional
Intervention
DIDALA hard capsules
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility 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.
Sites / Locations
- Hanoi Hospital of Traditional Medical
- National Hospital of Traditional Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DIDALA
METFORMIN
Arm Description
DIDALA is a herbal medicine, produced from dried mulberry leaves. The drug has been approved by the Drug Administration of Vietnam.
Outcomes
Primary Outcome Measures
Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c)
Hemoglobin A1c
Secondary Outcome Measures
Change from Baseline at Week 12 in Fasting Plasma Glucose
Fasting Plasma Glucose
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.
Full Information
NCT ID
NCT05760456
First Posted
January 30, 2023
Last Updated
February 27, 2023
Sponsor
Centre of Clinical Pharmacology, Hanoi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05760456
Brief Title
Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre of Clinical Pharmacology, Hanoi Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DIDALA
Arm Type
Experimental
Arm Description
DIDALA is a herbal medicine, produced from dried mulberry leaves. The drug has been approved by the Drug Administration of Vietnam.
Arm Title
METFORMIN
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DIDALA hard capsules
Intervention Description
DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks
Primary Outcome Measure Information:
Title
Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c)
Description
Hemoglobin A1c
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline at Week 12 in Fasting Plasma Glucose
Description
Fasting Plasma Glucose
Time Frame
12 weeks
Title
Safety assessments
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Centre of Clinical Pharmacology
Phone
+84 24 3852 3798
Ext
3188
Email
duoclylamsang@gmail.com
Facility Information:
Facility Name
Hanoi Hospital of Traditional Medical
City
Hanoi
Country
Vietnam
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanoi Hospital of Traditional Medical
Phone
+84 24 37684059
Email
bvdkyhcthn@hanoi.gov.vn
Facility Name
National Hospital of Traditional Medicine
City
Hanoi
Country
Vietnam
Facility Contact:
First Name & Middle Initial & Last Name & Degree
National Hospital of Traditional Medicine
Phone
84-4-3826361
Email
icc@nhtm.gov.vn
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.
We'll reach out to this number within 24 hrs