UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026022 |
|---|---|
| Receipt number | 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 09:53:04 |
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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
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
sadakenn@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
