UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010318 |
|---|---|
| Receipt number | 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 12:44:47 |
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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
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
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
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
msasaki@aichi-med-u.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012067
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
