Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients
NCT ID: NCT02844803
Last Updated: 2016-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
20 participants
INTERVENTIONAL
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Active drug-> Placebo
Metformin + S. Baicalensis --\> Metformin + Placebo
Combination of Metformin + S. Baicalensis
the combination therapy for 8 weeks
Combination of Metformin + Placebo
the metformin single therapy for 8 weeks
Placebo -> Active drug
Metformin + Placebo --\> Metformin + S. Baicalensis
Combination of Metformin + S. Baicalensis
the combination therapy for 8 weeks
Combination of Metformin + Placebo
the metformin single therapy for 8 weeks
Interventions
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Combination of Metformin + S. Baicalensis
the combination therapy for 8 weeks
Combination of Metformin + Placebo
the metformin single therapy for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Namyi Gu
OTHER
Responsible Party
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Namyi Gu
Assistant professor
Principal Investigators
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Han Seok Choi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dongguk University College of Medicine and Ilsan Hospital
Locations
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Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S.baicalensis-Metformin
Identifier Type: -
Identifier Source: org_study_id
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