UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010311 |
|---|---|
| Receipt number | R000012068 |
| Scientific Title | Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS) |
| Date of disclosure of the study information | 2013/03/25 |
| Last modified on | 2017/09/26 16:53:13 |
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Basic information
Public title
Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS)
Acronym
Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS)
Scientific Title
Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS)
Scientific Title:Acronym
Comparative efficacy of oral hypoglycemic agents to be added to biphasic insulin aspart-70 (BIAsp70) in Japanese type 2 diabetic patients by using continuous glucose monitoring system (CGMS)
Region
| Japan |
Condition
Condition
T2DM
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the optimal oral hypoglycemic agent (OHA) added to thrice-daily pre-meal biphasic insulin aspart 70 (BIAsp70) in Japanese type 2 diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Pre-breakfast blood glucose
2) Average of the blood glucose
3) Variability of the blood glucose
Key secondary outcomes
Frequency of hypoglycemia
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
BIAsp70
Interventions/Control_2
Addition of glimepiride (0.5 mg/day) to the BIAsp70
Interventions/Control_3
Addition of metformin (500 mg/day) to the BIAsp70
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
T2DM
Key exclusion criteria
1. Pregnant or intention of becoming pregnant
2. Patients who are judged by investigators to be inappropriate for inclusion in the study
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Tanaka |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Nagai |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 03 | Month | 25 | 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 | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 24 | Day |
Last modified on
| 2017 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012068
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
