UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007706 |
|---|---|
| Receipt number | R000009086 |
| Scientific Title | Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2014/10/31 08:50:06 |
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Basic information
Public title
Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Acronym
Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Scientific Title
Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Scientific Title:Acronym
Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of sitagliptin or miglitol combined with insulin therapy on the glycemic control and vascular functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The blood glucose fluctuations after meal test and vascular endothelial dysfunction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Interventions/Control_2
Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Type 2 diabetes who show postprandial hyperglycemia.
6.5% < HbA1c(JDS) < 8.5%
Key exclusion criteria
The exclusion criteria were patients who had taken glinid and sulfonylurea, type 1 diabetes, current history of diabetic ketoacidosis or diabetic come, and/or cerebral stroke, renal insufficiency (serum creatinnin > 1.5 in men, serum creatinin > 1.3 in women, sever infection, current history of operation or trauma, patients with hypersensitive for sitagliptin or miglitol, expectant mother, lactating woman, an age < 20, inappropriate patients judged by the physician in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Takemoto |
Organization
Chiba University Hospital
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
043-222-7171
minoru.takemoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Takemoto |
Organization
Chiba University Hospital
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
minoru.takemoto@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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 | 04 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009086
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
