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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 17 October 2023
Main ID:  JPRN-UMIN000015125
Date of registration: 12/09/2014
Prospective Registration: Yes
Primary sponsor: Japan Diabetes Clinical Data Manegement Study Group
Public 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: Time in Poor Glycaemic Control in People with Type 2 Diabetes Initiating Basal Insulin Treatment: a Cohort Study in the CODIC Database - Time in Poor Glycaemic Control in People with Type 2 Diabetes Initiating Basal Insulin Treatment
Date of first enrolment: 2014/10/01
Target sample size: 12400
Recruitment status: Complete: follow-up complete
URL:  https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017594
Study type:  Observational
Study design:  Not selected Not selected  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Tomoe    Sumi
Address:  715-1, Higashi-hiratuka, Tsukuba, Ibaraki, Japan, 305-0812 305-0812 Japan
Telephone: 029-852-1882
Email: info@jddm.jp
Affiliation:  Japan Diabetes Clinical Data Manegement Study Group Office
Name: Jo    Satoh
Address:  2-29-1 Yamatomachi, Wakabayashi-ku, Sendai, Japan 984-8560 Japan
Telephone: 022-236-5803
Email: josatoh@nifty.com
Affiliation:  NTT-East Tohoku Hospital Director
Key inclusion & exclusion criteria
Inclusion criteria:
Exclusion criteria: If there is an agreement to withdraw data use, exclude the summary.

Age minimum: 18years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Type 2 diabetes
Intervention(s)
Primary Outcome(s)
-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.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Novo Nordisk A/S
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date: 24/06/2014
Contact:
info@jddm.jp
Japan Diabetes Clinical Data Manegement Study Group
03-5521-2881
info@jddm.jp
Results
Results available: Yes
Date Posted: 22/12/2020
Date Completed: 31/12/2014
URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6143196/pdf/pone.0198160.pdf
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