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

Early Phase 1

• Conditions: Diabetes Mellitus
• Interventions: Drug: Combination of Metformin + S. Baicalensis; Drug: Combination of Metformin + Placebo

• Registration Number: NCT02844803
• Lead Sponsor: Namyi Gu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-26
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-03
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo -> Active drug	Combination of Metformin + S. Baicalensis	Metformin + Placebo --\> Metformin + S. Baicalensis
Placebo -> Active drug	Combination of Metformin + Placebo	Metformin + Placebo --\> Metformin + S. Baicalensis
Active drug-> Placebo	Combination of Metformin + Placebo	Metformin + S. Baicalensis --\> Metformin + Placebo
Active drug-> Placebo	Combination of Metformin + S. Baicalensis	Metformin + S. Baicalensis --\> Metformin + Placebo

Primary Outcome Measures

Name	Time	Method
Change of serum glucose level after 8 weeks from baseline	Day1 and Day 57 on the 1st and 2nd periods

Trial Locations

Locations (1)

Dongguk University Ilsan Hospital; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of