Back to resultsStudy of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
Primary Purpose
Diabetes Mellitus
Status
Unknown status
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Combination of Metformin + S. Baicalensis
Combination of Metformin + Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Diagnosed as a diabetes mellitus patient at least 3 months ago on screening
- Treated with metformin of ≥ 500 mg/day over 3 months on screening
- Fasting glucose level of 110~180 mg/dl or HbA1c of 7.0~9.0% on screening
Exclusion Criteria:
- With acute or chronic inflammation
- Treated with systemic corticosteroids within 4 weeks prior to the first administration of study medication
- With heart failure, myocardial infarction, stroke, or other acute severe cardiovascular diseases
- With acute or chronic renal failure or nephrotic syndrome
- With impaired hepatic function.
- Drug or Alcoholic abuser
- Pregnant or nursing woman
Sites / Locations
- Dongguk University Ilsan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Active drug-> Placebo
Placebo -> Active drug
Arm Description
Metformin + S. Baicalensis --> Metformin + Placebo
Metformin + Placebo --> Metformin + S. Baicalensis
Outcomes
Primary Outcome Measures
Change of serum glucose level after 8 weeks from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02844803
Brief Title
Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
Official Title
Pilot Study to Investigate the Effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Namyi Gu
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active drug-> Placebo
Arm Type
Other
Arm Description
Metformin + S. Baicalensis --> Metformin + Placebo
Arm Title
Placebo -> Active drug
Arm Type
Other
Arm Description
Metformin + Placebo --> Metformin + S. Baicalensis
Intervention Type
Drug
Intervention Name(s)
Combination of Metformin + S. Baicalensis
Intervention Description
the combination therapy for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Combination of Metformin + Placebo
Intervention Description
the metformin single therapy for 8 weeks
Primary Outcome Measure Information:
Title
Change of serum glucose level after 8 weeks from baseline
Time Frame
Day1 and Day 57 on the 1st and 2nd periods
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed as a diabetes mellitus patient at least 3 months ago on screening
Treated with metformin of ≥ 500 mg/day over 3 months on screening
Fasting glucose level of 110~180 mg/dl or HbA1c of 7.0~9.0% on screening
Exclusion Criteria:
With acute or chronic inflammation
Treated with systemic corticosteroids within 4 weeks prior to the first administration of study medication
With heart failure, myocardial infarction, stroke, or other acute severe cardiovascular diseases
With acute or chronic renal failure or nephrotic syndrome
With impaired hepatic function.
Drug or Alcoholic abuser
Pregnant or nursing woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Namyi Gu, MD, PhD
Phone
+82-31-961-8440
Email
namyi.gu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Han Seok Choi, MD, PhD
Phone
+82-31-961-5777
Email
hschoi402@dumc.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Seok Choi, MD, PhD
Organizational Affiliation
Dongguk University College of Medicine and Ilsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguk University Ilsan Hospital
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-773
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namyi Gu, MD, PhD
Phone
+82-31-961-8440
Email
namyi.gu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
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