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Name:
UMIN ID:

Recruitment status Completed
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 2020/12/22

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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

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
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 Jo
Middle name
Last name Satoh
Organization NTT-East Tohoku Hospital
Division name Director
Zip code 984-8560
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 Tomoe
Middle name
Last name Sumi
Organization Japan Diabetes Clinical Data Manegement Study Group
Division name Office
Zip code 305-0812
Address 715-1, Higashi-hiratuka, Tsukuba, Ibaraki, Japan, 305-0812
TEL 029-852-1882
Homepage URL http://jddm.jp/index.html
Email info@jddm.jp

Sponsor
Institute Japan Diabetes Clinical Data Manegement Study Group
Institute
Department

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 Japan Diabetes Clinical Data Manegement Study Group
Address 715-1, Higashi-hiratuka, Tsukuba, Ibaraki, Japan, 305-0812
Tel 03-5521-2881
Email info@jddm.jp

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 http://jddm.jp/member/handout/
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6143196/pdf/pone.0198160.pdf
Number of participants that the trial has enrolled 2351
Results 2351 patients initiated balsal insulin treatment, and 1279 patients were eligible for treatment intensification after 180 days titration period. Durimg the 1.5 years follow up period, 270 of tese patients received treatment intensification. In patients receiving treatment intensification , mean HbA1c decreased from 8.6 to 8.2% at end follow up. This study suggests clinical inertia exists in basal insulin treated patients with type 2 daiabetes in Japan.
Results date posted
2020 Year 12 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Patients were included in the overall study population if they had a diagnosis of T2D, were aged over 18 years, and were initiated on basal insulin between 2004 and 2011. 2351 patients, who initiated treatment with basal insulin, had a mean age of 60.7 years and a mean BMI of 24.5kg/m2. The study population were 64% male.
Participant flow Patients were eliglible for treatment intensification if they had at least 180 days of data from before basal insulin initiation, and HbAa1c over 7.0% after 180 days of basal insulin treatment, and up to 1.5 years of follow up data. 2351 patients initiated treatment with basal insulin, and 1279 patients were eligible for treatment initensification after the 180 days titration period. During the follow up period, 270 of these patients received treatment intensification due to HbA1v over 7.0%.
Adverse events As statistical methods, patients who did not intensify treatment were censored if HbA1c dropped below 7.0%, or transferred out of the database in the case of death or if there were missing data. Through this study, there were not adverse events.
Outcome measures Endpoints were time to intensification, changes in HbA1c and insulin dose. The estimated probability of intensifing treatment during 12 months after recoding HbA1c over 7.0% was 22.8%, and after 17 months was 27.5%. In patients receiving treatment intensification, mean HbA1c decreased 8.6 to 8.2% at end of follow up. Mean end of follow up daily insulin dose was 35.11 units doe basal-bolus compared with 20.70 units for premix therapy.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 07 Month 27 Day
Date of IRB
2014 Year 06 Month 24 Day
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
2020 Year 12 Month 22 Day


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

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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