UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046736 |
|---|---|
| Receipt number | R000053323 |
| Scientific Title | Multimorbidity, polypharmacy, and glucose-lowering drugs, and their effects in patients with type 2 diabetes: A longitudinal study of real-world data |
| Date of disclosure of the study information | 2022/01/26 |
| Last modified on | 2022/01/26 14:06:00 |
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Basic information
Public title
Multimorbidity, polypharmacy, and glucose-lowering drugs, and their effects in patients with type 2 diabetes: A longitudinal study of real-world data
Acronym
Multimorbidity, polypharmacy, and glucose-lowering drugs, and their effects in patients with type 2 diabetes
Scientific Title
Multimorbidity, polypharmacy, and glucose-lowering drugs, and their effects in patients with type 2 diabetes: A longitudinal study of real-world data
Scientific Title:Acronym
Multimorbidity, polypharmacy, and glucose-lowering drugs, and their effects in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand multimorbidity, polypharmacy, and prescription status of glucose-lowering drugs among patients with type 2 diabetes in clinical practice in Japan
To investigate the association between the development of severe hypoglycemia and patient characteristics such as multimorbidity, polypharmacy, and use of glucose-lowering drugs
To explore the association between glycemic control and patient characteristics
Basic objectives2
Others
Basic objectives -Others
Actual clinical practice
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Patient characteristics (multimorbidity, polypharmacy, and prescription status of glucose-lowering drugs, etc.)
2. Occurrence of severe hypoglycemia
3. Glycemic control
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
1. Patients with type 2 diabetes who were prescribed glucose-lowering drugs on an outpatient basis during the enrollment period (April 2017 - February 2020)
2. Patients who had been consecutively registered in the DeSC database for at least 1 year before the index month (the month when outpatient prescription of glucose-lowering drugs was started during the enrollment period)
3. Patients over the age of 18 in the index month
Key exclusion criteria
none
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
tpm-com@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ruriko |
| Middle name | |
| Last name | Koto |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
Homepage URL
tpm-com@umin.ac.jp
Sponsor or person
Institute
Teijin Pharma Limited
Institute
Department
Personal name
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
Teijin Pharma Limited
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
Tel
03-3506-4140
tpm-com@umin.ac.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
| 2022 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a longitudinal study using the DeSC Database.
Management information
Registered date
| 2022 | Year | 01 | Month | 26 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053323
