UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026134 |
|---|---|
| Receipt number | 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 | 2021/10/05 19:08:23 |
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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 | Shinichiro |
| Middle name | |
| Last name | Maekawa |
Organization
MSDK.K.
Division name
Pharmacovigilance Area
Zip code
1028667
Address
1-13-12Kitanomaru-sukquare,Kudankita,Chiyoda-ku,Tokyo
TEL
09050536703
mitsuyoshi.hara@merck.com
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Umeki |
Organization
MSDK.K.
Division name
Pharmacovigilance Area
Zip code
1028667
Address
1-13-12Kitanomaru-sukquare,Kudankita,Chiyoda-ku,Tokyo
TEL
09050536703
Homepage URL
yoshie.umeki@merck.com
Sponsor or person
Institute
MSDK.K.
Institute
Department
Personal name
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2016 | Year | 01 | Month | 31 | Day |
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
| 2021 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.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 |
