Verifying the control effects of glucose absorption through the comparison of SekirenB2 with a placebo in double blind cross over comparative study.

JRCT ID: jRCT1091220179

Registered date:21/05/2014

Basic Information

• Recruitment status: COMPLETED

Health condition(s) or Problem(s) studied

1)HbA1c: 6.4% or less
2)HbA1c: 6.5% or more and less than 7.0%

• Date of first enrollment: 24/05/2014
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention type:DRUG
Name of intervention:SekirenB2
Dose form / Japanese Medical Device Nomenclature:CAPSULE
Route of administration / Site of application:ORAL
Dose per administration:900
mg
Dosing frequency / Frequency of use:ONCE
Planned duration of intervention:
Intended dose regimen:
detailes of teratment arms:
Comparative intervention name:Purasebo
Dose form / Japanese Medical Device Nomenclature:CAPSULE
Route of administration / Site of application:ORAL
Dose per administration:900
mg
Dosing frequency / Frequency of use:ONCE
Planned duration of intervention:
Intended dose regimen:

Outcome(s)

• Primary Outcome: We check amount of change of glucose level after ingesting.
• Secondary Outcome: We check safety and the amount of change value by a general blood test, biochemical examination and urinalysis.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1)A person who is Japanese and between 20 and 65 years old at the time of informed consent.(Sex is not asked)

2)A person who has blood pressure and body temperature of the following value at this clinical trial and the screening.
Blood pressure:
Systolic Less than 140mmHg
Diastolic Less than 90mmHg
Body temperature: 35.5-37.0 degrees

3)A person whose HbA1c is applied to following either value.
a)HbA1c:6.4% or less
b)HbA1c:6.5% or more and less than 7.0%

4)A person must be received to explanation about the test food,objective of clinical test and side effects by clinical research investigator or sub investigator.
And the person who understood explanation well,agreed with written informed consent and desired participation in the clinical trial.

5)A person who can quit smoking on the day of clinical trial.

6)A person who can obey management manner in implementation medical institutions.

7)A person who can do screening test within 60 days of this clinical trials implementation and was qualified by clinical research investigator or sub clinical research investigator.

Exclude criteria

A person who is suspected to have an impaired liver function on result of clinical laboratory test at the screening.
a) T-Bil 3.0 or more
b) GOT,GPT More than normalcy upper limit multiply 2.5(100 or more)
c) A1-P More than normalcy upper limit multiply 2.5
d) gamma-GTP More than normalcy upper limit multiply 1.5
e) LDH More than normalcy upper limit multiply 1.5
2) A person who has disease of gastrointestinal tract, kidney and the heart which have an influence on absorption, distribution, metabolism and the excretion.
3) A person who has surgical history of gastrointestinal tract site.
For example gastrectomy, stomach and intestines suture, intestinal tract resection and so on.
4) A person who has food allergy.
5) A person who has alcohol or drug dependence.
6) A person who treated diabetes within 3 months at the time of obtaining informed consent.
7) A person who participated in other clinical study of new drug or received medical treatment within 3 months at the time of obtaining informed consent.
8) A person who take other medicine from less than one week to start this clinical trial.
9) A person who has taken the whole blood bleeds or ingredient blood collecting (plasma or plaque component blood collecting) more than 200ml within 3 months at the time of obtaining informed consent or during the period between the time of obtaining informed consent and this clinical trial implementation.
10) A person who can't obey management manner or can't report about subjective symptoms during participation in clinical trials.
11) In addition a person who is identified as improper by the responsibility researcher or subresponsibility researcher.
12) A woman who is pregnant or breastfeeding.

Related Information

• Primary Sponsor: ADAPTGEN PHARMACEUTICAL CO.,LTD.

Secondary Sponsor

1,Medical institutions conduct clinical research
MEDOC Medical Dock&Clinic
2,CRO
Medical Fusion Co.,Ltd

• Source(s) of Monetary Support: ADAPTGEN PHARMACEUTICAL CO.,LTD.
• Secondary ID(s): Nill Known,JMA-IIA00179