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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026134
Receipt No. R000030030
Scientific Title oMARIgliptin once A week dpp-4 inhibitor post-marketinG surveillance on safety and Efficacy
Date of disclosure of the study information 2017/02/14
Last modified on 2017/02/14

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Basic information
Public title oMARIgliptin once A week dpp-4 inhibitor post-marketinG surveillance on safety and Efficacy
Acronym MARIAGE
Scientific Title oMARIgliptin once A week dpp-4 inhibitor post-marketinG surveillance on safety and Efficacy
Scientific Title:Acronym MARIAGE
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the long-term safety and efficacy of omarigliptin, detect new issues, and confirm the safety of omarigliptin specified in the Risk Management Plan, in the general patient population with type 2 diabetes (T2DM) and in the population of patients with T2DM with moderate or severe renal impairment, including those requiring hemodialysis or peritoneal dialysis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [Safety]
The incidence of side effects(Primary endpoint)
[Efficacy]
Overall impression on efficacy
HbA1c change from baseline
[Other]
Compliance status
Concomitant therapies
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Omarigliptin naive patients with type 2 diabetes who are eligible for long-term use.
Key exclusion criteria Not applicable
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Hara
Organization MSDK.K.
Division name Pharmacovigilance Area
Zip code
Address Kitamomaru Square, 1-13-12, Kudan-kita,Chiyoda-ku,Tokyo, Japan
TEL 03-6272-2023
Email mitsuyoshi.hara@merck.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshie Umeki
Organization MSDK.K.
Division name Pharmacovigilance Area
Zip code
Address Kitamomaru Square, 1-13-12, Kudan-kita,Chiyoda-ku,Tokyo, Japan
TEL 03-6272-2023
Homepage URL
Email yoshie.umeki@merck.com

Sponsor
Institute MSDK.K.
Institute
Department

Funding Source
Organization MSDK.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
Address
Tel
Email

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 02 Month 14 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 Enrolling by invitation
Date of protocol fixation
2015 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The survey will be conducted by a prospective central registration method using Electronic Data Capture(EDC). Electronic signatures will be used for physician's signatures.
The observation period is at least 3 years after the start of administration of omarigliptin. After the completion of the observation period at 3 months and each observation year, the investigator will complete CRF screens and physicians must enter the data up to the day of patient's final administration day.
<Analysis items and Method>
1)Items related to disposition of patients
2)Items related to the safety
Incidence of adverse reactions and infections.Factors possibly affecting the safety.
3)Items related to the efficacy
Overall impression on efficacy, change in HbA1c, and patient demographic characteristics
4)Compliance status
Early entry 500 cases investigate.
5)Analytical methods
Summary statistics will be calculated for the safety and efficacy items according to the nature of the data. Analyses, if deemed necessary, will be performed according to appropriate analytical methods.

Management information
Registered date
2017 Year 02 Month 14 Day
Last modified on
2017 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030030

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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