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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011287
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute General incorporated Tokyo Physicians Association.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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