UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026466 |
|---|---|
| Receipt number | R000030187 |
| Scientific Title | Adherence to Dipeptidyl Peptidase-4 Inhibitors or Biguanidesand Associating Factors Related to Adherence in Patients with Type 2 Diabetes Mellitus: Observational, Cross-Sectional, Pharmacy-Based Survey |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/12/16 15:14:55 |
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Basic information
Public title
Adherence to Dipeptidyl Peptidase-4 Inhibitors or Biguanidesand Associating Factors Related to Adherence in Patients with Type 2 Diabetes Mellitus: Observational, Cross-Sectional, Pharmacy-Based Survey
Acronym
Adherence to Dipeptidyl Peptidase-4 Inhibitors or Biguanidesand Associating Factors Related to Adherence in Patients with Type 2 Diabetes Mellitus: Observational, Cross-Sectional, Pharmacy-Based Survey
Scientific Title
Adherence to Dipeptidyl Peptidase-4 Inhibitors or Biguanidesand Associating Factors Related to Adherence in Patients with Type 2 Diabetes Mellitus: Observational, Cross-Sectional, Pharmacy-Based Survey
Scientific Title:Acronym
Adherence to Dipeptidyl Peptidase-4 Inhibitors or Biguanidesand Associating Factors Related to Adherence in Patients with Type 2 Diabetes Mellitus: Observational, Cross-Sectional, Pharmacy-Based Survey
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine adherence rate to DPP-4i (QD), DPP-4i (BID) or biguanide (BID) monotherapy during 7 days just prior to the survey in T2DM patients having at least 30 days of prior prescription
Basic objectives2
Others
Basic objectives -Others
To examine factors associating with good adherence in entire population or in each group treated with DPP-4i (QD), DPP-4i (BID) or biguanide (BID) monotherapy during 7 days prior to the survey
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Adherence measured as the numbers of days missed any dose(s) during the 7 days prior to the survey
Key secondary outcomes
Adherence measured as the numbers of days missed any dose(s) during the 30 days prior to the survey
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed with T2DM
Receiving medical treatment at clinics/hospitals in Japan
The patients themselves who are currently prescribed DPP-4i (QD or BID) or biguanide (BID, 1 pill at a time) as monotherapy for at least last prescription period
Having such a drug at an identical pharmacy with at least more than 30 day-prescription in the last visit
The patient able to read, write, and smoothly communicate in Japanese
Providing informed consent
Key exclusion criteria
Pregnant at any time of the study period
Type 1 diabetes
Prescribed DPP-4i (QW) or biguanide (other than BID with 1 pills at a time)
Taking any other concomitant medications including prescribed oral drug or injectable drugs,during the last prescription period of DPP-4i (OD or BID) or biagunide BID, 1 pill at a time)
Target sample size
845
Research contact person
Name of lead principal investigator
| 1st name | Takekazu |
| Middle name | |
| Last name | Kubo |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
102-8667
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-2338
ldgproject@merck.com
Public contact
Name of contact person
| 1st name | Takekazu |
| Middle name | |
| Last name | Kubo |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
102-8667
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-2338
Homepage URL
ldgproject@merck.com
Sponsor or person
Institute
MSD K.K.
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
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
Independent Ethics Committee in school of pharmacy, Nihon University
Address
7-7-1, Narashinodai, Funabashi-shi, Chiba
Tel
047-465-2111
pha.res-staff@nihon-u.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
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/yakushi/139/12/139_18-00197/_article/-char/ja
Number of participants that the trial has enrolled
1016
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to programming misstakes, the statistical analysis results had been largely delayed.
Date of the first journal publication of results
| 2019 | Year | 12 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
AEs had not been collected.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 06 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 06 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 02 | Day |
Other
Other related information
Pharmacy-based survey for adherence in T2DM using questionnaire
Management information
Registered date
| 2017 | Year | 03 | Month | 08 | Day |
Last modified on
| 2020 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030187
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| Registered date | File name |
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