UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008692 |
|---|---|
| Receipt number | R000010217 |
| Scientific Title | Study of the combination use effect of DPP-4 inhibitor and alpha-glucosidase inhibitor |
| Date of disclosure of the study information | 2012/08/16 |
| Last modified on | 2015/03/24 09:07:17 |
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Basic information
Public title
Study of the combination use effect of DPP-4 inhibitor and alpha-glucosidase inhibitor
Acronym
Study of the combination use effect of DPP-4 inhibitor and alpha-glucosidase inhibitor
Scientific Title
Study of the combination use effect of DPP-4 inhibitor and alpha-glucosidase inhibitor
Scientific Title:Acronym
Study of the combination use effect of DPP-4 inhibitor and alpha-glucosidase inhibitor
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the combination use effect of DPP-4 inhibitor and alpha-glucosidase inhibitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alteration of HbA1c between 0 month and 3 months.
Key secondary outcomes
post-meal 2 hours GLP-1, GIP, glucagon
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sitagliptin 50-100mg, once daily, oral
Acarbose 50-100 mg, 1-3 times daily, oral
Duration 3 months
Interventions/Control_2
Sitagliptin 50-100mg, daily, oral
Voglibose 50-100 mg, 1-3 times daily, oral
Duration 3 months
Interventions/Control_3
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Type 2 Diabetes Mellitus (HbA1c level: more than 5.8% (JDS))
2)Patients with written IC
Key exclusion criteria
1) Severe ketosis,deabetic coma or precoma,type1diabetes
2) Patients before or after operation, and those with severe infections or serious injury
3) Pregnant
4) Patients with a history of hypersensitibity to the study drug
5)Patients who use of other DPP4 inhibitor or other alpha glucosidase inhibitor
6) Patients judged by the investigator to be ineligible for some other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Toyoda |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
m-toyoda@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wakana Miura |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
Homepage URL
happy0897@gmail.com
Sponsor or person
Institute
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 15 | Day |
Last modified on
| 2015 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010217
