UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000010318
Receipt No. R000012067
Scientific Title Effects of transglucosidase on diabetes, cardiovascular risk factors, and hepatic biomarkers in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled trial
Date of disclosure of the study information 2013/03/26
Last modified on 2013/03/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of transglucosidase on diabetes, cardiovascular risk factors, and hepatic biomarkers in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled trial
Acronym TG Effect on Diabete
Scientific Title Effects of transglucosidase on diabetes, cardiovascular risk factors, and hepatic biomarkers in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym TG Effect on Diabete
Region
Japan

Condition
Condition Patients
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect on diabetes patients of transglucosidase
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the change of HbA1c of diabetes patients after transglucosidase treatment
Key secondary outcomes To evaluate the change of fasting blood glucose, HOMA-IR, and intestinal microbiota of diabetes patients after transglucosidase treatment

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Placebo 3 times/day after every meal
Interventions/Control_2 Transglucosidase 100mg 3 times after every meal
Interventions/Control_3 Transglucosidase 300mg 3 times after every meal
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who were diagnosed to type-2 diabetes according to the diagnosis criteria of diabetes mellitus of the Japanese Diabetes Society.
2) Patients whose HbA1c level was between 5.8 and 7.5% at screening.
3) Patiens who had stable dosages of medication for at least 1 month.
4) Patients who were stable diabetes condition for at least 3 months (change in HbA1c less than 1.0%).
Key exclusion criteria Patients who had a history of gut resection.
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Sasaki
Organization Aichi Medical University
Division name Gastroenterology
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
TEL +81-561-62-3311
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Sasaki
Organization Aichi Medical University
Division name Gastroenterology
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
TEL +81-561-62-3311
Homepage URL
Email msasaki@aichi-med-u.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Clinical Pharmacology,
Nagoya City University,
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2007 Year 09 Month 12 Day
Last follow-up date
2009 Year 08 Month 31 Day
Date of closure to data entry
2012 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 26 Day
Last modified on
2013 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012067


Contact us.