Diabetes Mellitus
Conditions
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.
Interventions
DRUGCombination of Metformin + S. Baicalensis
the combination therapy for 8 weeks
DRUGCombination of Metformin + Placebo
the metformin single therapy for 8 weeks
Sponsors
Namyi Gu
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of serum glucose level after 8 weeks from baseline | Day1 and Day 57 on the 1st and 2nd periods |
Countries
South Korea
Contacts
Primary ContactNamyi Gu, MD, PhD
Backup ContactHan Seok Choi, MD, PhD
Outcome results
None listed