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

August 2, 2016 updated by: Namyi Gu

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-773
        • Recruiting
        • Dongguk University Ilsan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Day1 and Day 57 on the 1st and 2nd periods
Day1 and Day 57 on the 1st and 2nd periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namyi Gu

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • S.baicalensis-Metformin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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