Study of Metformin and S. Baicalensis Combination Therapy... | NCT02844803

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

NCT02844803

Sponsor

Namyi Gu

Status

Unknown status

Last Update Posted

Aug 3, 2016Estimated

Enrollment

20Estimated

Phase

Early Phase 1

Conditions

Diabetes Mellitus

Interventions

Combination of Metformin + S. Baicalensis
Combination of Metformin + Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Not provided

First Submitted Date

Jul 22, 2016

First Submission Date that Met QC Criteria

Jul 25, 2016

First Posted Date

Jul 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2016

Last Update Posted Date

Aug 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active drug-> Placebo	Other	Metformin + S. Baicalensis --> Metformin + Placebo	Drug: Combination of Metformin + S. Baicalensis Drug: Combination of Metformin + Placebo
Placebo -> Active drug	Other	Metformin + Placebo --> Metformin + S. Baicalensis	Drug: Combination of Metformin + S. Baicalensis Drug: Combination of Metformin + Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combination of Metformin + S. Baicalensis	Drug	the combination therapy for 8 weeks	Active drug-> Placebo Placebo -> Active drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Namyi Gu, MD, PhD	Contact	+82-31-961-8440		namyi.gu@gmail.com
Han Seok Choi, MD, PhD	Contact	+82-31-961-5777		hschoi402@dumc.or.kr

Overall Officials

Name	Affiliation	Role
Han Seok Choi, MD, PhD	Dongguk University College of Medicine and Ilsan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongguk University Ilsan Hospital	Recruiting	Goyang-si	Gyeonggi-do	410-773	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided