UMIN-CTR Clinical Trial

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
Email	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
Email	ldgproject@merck.com

Sponsor
Institute	MSD K.K.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030187