UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015588 |
|---|---|
| Receipt number | R000018116 |
| Scientific Title | A pilot study on prevention of glucocorticoid induced diabetes mellitus by linagliptin |
| Date of disclosure of the study information | 2014/12/24 |
| Last modified on | 2020/11/06 13:52:38 |
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Basic information
Public title
A pilot study on prevention of glucocorticoid induced diabetes mellitus by linagliptin
Acronym
A pilot study on prevention of glucocorticoid induced diabetes mellitus by linagliptin (P-GDM-Lina)
Scientific Title
A pilot study on prevention of glucocorticoid induced diabetes mellitus by linagliptin
Scientific Title:Acronym
A pilot study on prevention of glucocorticoid induced diabetes mellitus by linagliptin (P-GDM-Lina)
Region
| Japan |
Condition
Condition
Patients scheduled administration of glucocorticoid
Classification by specialty
| Medicine in general | Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety for prevention of glucocorticoid induced diabetes mellitus by linagliptin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of development of glucocorticoid induced diabetes mellitus within 1 month
Key secondary outcomes
Concomitant insulin use
Concomitant anti-diabetic drug
Adverse effect
Change in HbAic
Change in HOMA-IR
Change in glycoalbumin
Change in 1.5-AG
Change in adiponectin
Change in glucagon
Change in cortisol
Change in leptin
Change in serum and urine CPR
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Concomitant administration of linagliptin at start of GC administration
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
1) Administration of 20mg/day or more of prednisone is scheduled
2) Not fulfilled below criteria for diabetes mellitus
a) HbA1c >= 6.5 %
b) fasting blood glucose level >= 126 mg/dL
c) blood glucose level at 2hr on OGTT >= 200mg/dL or casual blood glucose level >= 200mg/dL
3) At least either one of following risk factor for glucocorticoid induced diabetes mellitus
a) eGFR =< 60ml/min/1.73m2
b) 65 year or older
c) HbA1c > 6.0 %
4) Informed consent is obtained
Key exclusion criteria
1) < 20 years old
2) Inability of internal use
3) Pregnancy
4) Glucocorticoid pulse therapy is scheduled
5) Malignancy
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Ken-ei |
| Middle name | |
| Last name | Sada |
Organization
Department of Nephrology, Rheumatology, Endocrinology and Metabolism,
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan
TEL
086-235-7235
sadakenn@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshia |
| Middle name | |
| Last name | Miyawaki |
Organization
Okayama University Graduate Schoolof of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan
TEL
086-235-7235
Homepage URL
yoshia0316@gmail.com
Sponsor or person
Institute
Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
86-235-7361
ouh-crrb@adm.okayama-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
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 24 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 02 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018116
