Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
Pilot Study to Investigate the Effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedAugust 3, 2016
August 1, 2016
11 months
July 22, 2016
August 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change of serum glucose level after 8 weeks from baseline
Day1 and Day 57 on the 1st and 2nd periods
Study Arms (2)
Active drug-> Placebo
OTHERMetformin + S. Baicalensis --\> Metformin + Placebo
Placebo -> Active drug
OTHERMetformin + Placebo --\> Metformin + S. Baicalensis
Interventions
the combination therapy for 8 weeks
the metformin single therapy for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Namyi Gulead
Study Sites (1)
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han Seok Choi, MD, PhD
Dongguk University College of Medicine and Ilsan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
July 22, 2016
First Posted
July 26, 2016
Study Start
July 1, 2016
Primary Completion
June 1, 2017
Last Updated
August 3, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share