UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034083 |
|---|---|
| Receipt number | R000038812 |
| Scientific Title | Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/09/05 21:54:17 |
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Basic information
Public title
Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes
Acronym
Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes
Scientific Title
Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes
Scientific Title:Acronym
Efficacy of GLP-1 receptor agonists for steroid-induced hyperglycemia in patients with diabetes
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of GLP-1 receptor agonists as an add-on therapy to insulin for steroid-induced hyperglycemia in patients with diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic control and total daily insulin dose
Key secondary outcomes
Glycemic variation, adverse events including hypoglycemia, body weight, blood pressure, and lipid profile
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treat patients with insulin
Interventions/Control_2
treat patients with insulin and GLP-1 receptor agonists
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) Subjects with diabetes
2) Subjects who routinely take oral or intravenous steroids
3) Subjects who agree to participate in the study with oral and written informed consent
Key exclusion criteria
1) Subjects who refuse to participate in the study
2) Subjects who type 1 diabetes
3) Subjects with insulin-dependent diabetes
4) Subjects who used GLP-1 receptor agonists within one month
5) Subjects who are critically ill
6) Subjects who have difficulty participating in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Hamasaki |
Organization
Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name
Center for diabetes and endocrinology
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN, 530-8480
TEL
06-6312-1221
a-hamasaki@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yoshiji |
Organization
Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name
Center for diabetes and endocrinology
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN, 530-8480
TEL
06-6312-1221
Homepage URL
s-yoshiji@kitano-hp.or.jp
Sponsor or person
Institute
Center for diabetes and endocrinology, Tazuke Kofukai Medical Research Institute, Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
Center for diabetes and endocrinology, Tazuke Kofukai Medical Research Institute, Kitano Hospital
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
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
公益財団法人田附興風会医学研究所 北野病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | 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
| 2018 | Year | 09 | Month | 10 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038812
