UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011287 |
|---|---|
| Receipt number | R000013224 |
| Scientific Title | Study on insulin treatment for type 2 diabetes performed by general practitioners |
| Date of disclosure of the study information | 2013/07/26 |
| Last modified on | 2014/05/02 18:00:29 |
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Basic information
Public title
Study on insulin treatment for type 2 diabetes performed by general practitioners
Acronym
Study on insulin treatment for type 2 diabetes performed by general practitioners (Simple-i)
Scientific Title
Study on insulin treatment for type 2 diabetes performed by general practitioners
Scientific Title:Acronym
Study on insulin treatment for type 2 diabetes performed by general practitioners (Simple-i)
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Voluntary consent for participation in the study will be obtained from type 2 diabetes patients who are willing to undergo insulin therapy with the study drug. A group of general practitioners will exploratorily monitor the state of diabetes (changes in HbA1c, blood glucose, etc.). Questionnaire surveys of the investigator and patients will also be carried outs.
Basic objectives2
Others
Basic objectives -Others
Explanatory monitoring of the state of diabetes (changes in HbA1c, blood glucose, etc.)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in HbA1c from baseline at the specified measurement times (every four weeks)
Key secondary outcomes
- Changes in HbA1c from baseline (Week 0) at the specified measurement times (every four weeks) in patients undergoing insulin therapy with the study drug
- Changes from baseline in self-measurement of blood glucose (SMBG) (wake up time, SMBG for five days of the week before or/and after the specified day) at specified measurement times (every four weeks)
- Changes in the dose of the study drug at specified measurement times (every four weeks)
- Changes from baseline (Week 0) in early-morning fasting blood glucose level and BMI at study completion (Week 12)
- Changes from baseline (Week 0) in liver function, renal function, and lipid test values at study completion (Week 12)
- Information on onset of hypoglycemia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Type 2 diabetes patients aged 20 years or more who are willing to undergo insulin therapy with the study drug are eligible for the present study. Voluntary consent for participation in the study must be obtained in writing from the eligible patients.
Key exclusion criteria
Females during pregnancy or lactation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Sugawara |
Organization
General incorporated Tokyo Physicians Association.
Division name
Chairman
Zip code
Address
Tokyo Medical Association hall 3F , 2-5 Kandasurugadai ,Chiyoda-ku,Tokyo,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Satt Co., Ltd.
Division name
Customer Satisfaction Department
Zip code
Address
Urbanprem Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-5312-5026
Homepage URL
Sponsor or person
Institute
General incorporated Tokyo Physicians Association.
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 | 07 | Month | 26 | 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
| 2013 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 02 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 23 | Day |
Other
Other related information
Voluntary consent for participation in the study will be obtained from type 2 diabetes patients who are willing to undergo insulin therapy with the study drug. A group of general practitioners will exploratorily monitor the state of diabetes (changes in HbA1c, blood glucose, etc.). Questionnaire surveys of the investigator and patients will also be carried outs.
Management information
Registered date
| 2013 | Year | 07 | Month | 26 | Day |
Last modified on
| 2014 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013224
