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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026022
Receipt No. R000029707
Scientific Title Treatment of glucocorticoid induced hyperglycemia in patients with type 2 diabetes mellitus with omarigliptin at Okayama university hospital: an open label randomized controlled trial
Date of disclosure of the study information 2017/04/19
Last modified on 2018/02/08

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Basic information
Public title Treatment of glucocorticoid induced hyperglycemia in patients with type 2 diabetes mellitus with omarigliptin at Okayama university hospital: an open label randomized controlled trial
Acronym Good-MOMO study
Scientific Title Treatment of glucocorticoid induced hyperglycemia in patients with type 2 diabetes mellitus with omarigliptin at Okayama university hospital: an open label randomized controlled trial
Scientific Title:Acronym Good-MOMO study
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Medicine in general Nephrology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether omarigliptin reduce the requirement of insulin therapy in patients with type 2 diabetes mellitus treated with glucocorticoids for kidney disease or rheumatic disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion of patients who were treated with insulin or whose plasma glucose levels elevated above 200mg/dL
Key secondary outcomes 1) Insulin therapy
2) Other treatments of DM
3) Adverse events
4) HbA1c
5) Glycoalbumin
6) 1,5-AG

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Omarigliptin
Interventions/Control_2 Standard therapy
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 1) Prednisolone >=15mg/day will be taken
2) Type 2 diabetes mellitus
Key exclusion criteria 1) Type 1 diabetes mellitus
2) Concomitant glucocorticoid pulse therapy
3) Treated with insulin or dipeptidyl peptidase-4 inhibitor
4) Malignancy
5) Pregnant or breastfeeding
6) Difficulty in taking pills
7) Autoimmune pancreatitis
8) Patients who are considered as inappropriate for attending this study by their physicians
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ei Sada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL +81-86-222-5214
Email sadakenn@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken-ei Sada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL +81-86-222-5214
Homepage URL
Email sadakenn@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Other
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 04 Month 19 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 Terminated
Date of protocol fixation
2017 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 07 Day
Last modified on
2018 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029707

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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