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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015125
Receipt No. R000017594
Scientific Title Time in Poor Glycaemic Control in People with Type 2 Diabetes Initiating Basal Insulin Treatment: a Cohort Study in the CODIC Database
Date of disclosure of the study information 2014/09/12
Last modified on 2014/09/16

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Basic information
Public title Time in Poor Glycaemic Control in People with Type 2 Diabetes Initiating Basal Insulin Treatment: a Cohort Study in the CODIC Database
Acronym Time in Poor Glycaemic Control in People with Type 2 Diabetes Initiating Basal Insulin Treatment
Scientific Title Time in Poor Glycaemic Control in People with Type 2 Diabetes Initiating Basal Insulin Treatment: a Cohort Study in the CODIC Database
Scientific Title:Acronym Time in Poor Glycaemic Control in People with Type 2 Diabetes Initiating Basal Insulin Treatment
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate time in poor glycemic control until intensification defined by adding GLP-1 or bolus insulin to existing basal insulin treatment or by initiating premix insulin treatment.
Basic objectives2 Others
Basic objectives -Others To clarify an association between additional treatments and time in poor glycemic control.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Investigate the period between treatment changed from the start of the Basal insulin, to assess the effect of each factor by using a covariate analysis
-For Basal insulin-treated patients, describes a time to make a change in therapy from the state (if more than 7.5 HbA1c value) glycemic control is not enough to assess the impact of influence each factor at the time of treatment change.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria In the present study participating centers,
The subjects (with a visit history of 6 months or more) patients who started the treatment of basal insulin during the September 30, 2011 from January 1, 2004, and 18 years of age or older.
Key exclusion criteria If there is an agreement to withdraw data use, exclude the summary.
Target sample size 12400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jo Satoh
Organization NTT-East Tohoku Hospital
Division name Director
Zip code
Address 2-29-1 Yamatomachi, Wakabayashi-ku, Sendai, Japan 984-8560
TEL 022-236-5803
Email josatoh@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Jo Satoh
Organization Japan Diabetes Clinical Data Manegement Study Group
Division name Office
Zip code
Address Soshinsya 2-8-11 Nishishinjuku Minato-ku, Tokyo, Japan, 105-0003
TEL 03-5521-2881
Homepage URL http://jddm.jp/index.html
Email kouhou@jddm.jp

Sponsor
Institute Japan Diabetes Clinical Data Manegement Study Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Novo Nordisk A/S
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 09 Month 12 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 Preinitiation
Date of protocol fixation
2014 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is to analyaze the data which were already regisitered to the Japan Diabetes Data Manegement Study Group.

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2014 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017594


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