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NCT02844803 Clinical Trial

Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients

Diabetes Mellitus Clinical Trial

Official title:
Pilot Study to Investigate the Effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02844803
Other study ID # S.baicalensis-Metformin
Secondary ID
Status Recruiting
Phase Phase 0
First received July 22, 2016
Last updated August 2, 2016
Start date July 2016

Study information
Verified date August 2016
Source DongGuk University
Contact Namyi Gu, MD, PhD
Phone +82-31-961-8440
Email namyi.gu@gmail.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Combination of Metformin + S. Baicalensis
the combination therapy for 8 weeks
• Combination of Metformin + Placebo
the metformin single therapy for 8 weeks

Locations
Country Name City State
Korea, Republic of Dongguk University Ilsan Hospital Goyang Gyeonggi

Sponsors (1)
Lead Sponsor Collaborator
Namyi Gu

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of serum glucose level after 8 weeks from baseline Day1 and Day 57 on the 1st and 2nd periods No
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