UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015125 |
|---|---|
| Receipt number | 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 16:07:04 |
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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
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
info@jddm.jp
Sponsor or person
Institute
Japan Diabetes Clinical Data Manegement Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017594
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