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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Combination of Metformin + S. Baicalensis; Drug: Combination of Metformin + Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Namyi Gu, MD, PhD; Phone Number: +82-31-961-8440; Email: namyi.gu@gmail.com
• Study Contact Backup: Name: Han Seok Choi, MD, PhD; Phone Number: +82-31-961-5777; Email: hschoi402@dumc.or.kr

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Goyang, Gyeonggi, Korea, Republic of, 410-773
      • Recruiting
      • Dongguk University Ilsan Hospital
      • Contact: Namyi Gu, MD, PhD; Phone Number: +82-31-961-8440; Email: namyi.gu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active drug-> Placebo; Metformin + S. Baicalensis --> Metformin + Placebo	Drug: Combination of Metformin + S. Baicalensis; the combination therapy for 8 weeks; Drug: Combination of Metformin + Placebo; the metformin single therapy for 8 weeks
Other: Placebo -> Active drug; Metformin + Placebo --> Metformin + S. Baicalensis	Drug: Combination of Metformin + S. Baicalensis; the combination therapy for 8 weeks; Drug: Combination of Metformin + Placebo; the metformin single therapy for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Namyi Gu
• Investigators: Principal Investigator: Han Seok Choi, MD, PhD, Dongguk University College of Medicine and Ilsan Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Estimate): August 3, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: S.baicalensis-Metformin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO