UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007032 |
|---|---|
| Receipt number | R000008268 |
| Scientific Title | The effect of alogliptin against steroid-induced diabetes mellitus |
| Date of disclosure of the study information | 2012/01/06 |
| Last modified on | 2014/01/06 14:37:42 |
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Basic information
Public title
The effect of alogliptin against steroid-induced diabetes mellitus
Acronym
The effect of alogliptin against steroid-induced diabetes mellitus
Scientific Title
The effect of alogliptin against steroid-induced diabetes mellitus
Scientific Title:Acronym
The effect of alogliptin against steroid-induced diabetes mellitus
Region
| Japan |
Condition
Condition
chronic kidney disease
steroid-induced diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether alogliptin improves steroid-induced diabetes mellitus. If so, we will also clarify the mechanism of the improvement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Fasting blood glucose level
2. Hemoglobin A1c
3. Postprandial blood glucose level in two hours after lunch
Key secondary outcomes
4. HOMA-R (index of insulin resistance)
5. HOMA-beta (index of insulin secretion from pancreatic beta cell)
6. DPP-4
7. incretin (Glucagon-like peptide-1)
8. glucagon
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alogliptin is administered to steroid-induced diabetes mellitus patients that are suffered from chronic kidney disease.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) the patients that are not suffered from diabetes mellitus
( The patients have no thirsty, polyposia, polyuria, or body weight loss that is suspicious for diabetes mellitus.
Fasting glucose level<126mg/dl, postplandial blood glucose level<200mg/dl, and HbA1c<6.1%)
The patients have no diabetic retinopathy.
2) Diabetes mellitus is induced during steroid administration. At least, one of 3 components (fasting glucose level>126mg/dl, postplandial blood glucose level>200mg/dl, or HbA1c>6.1%) are detected during steroid administration.
Key exclusion criteria
1) the patients that are suffered from diabetes mellitus
The patients have thirsty, polyposia, polyuria or body weight loss that is suspicious for diabetes mellitus.
Fasting glucose level>126mg/dl, postplandial blood glucose level>200mg/dl, and HbA1c>6.1%
The patients have diabetic retinopathy.
2) the patients that are not suffered from severe alcholic liver damage
3) the patients that experience the administration of DPP-4 inhibitor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naro Ohashi |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Medicine
Zip code
Address
1-20-1 Handayama Higashi-ku Hamamatsu, 431-3192, Japan
TEL
053-435-2111
ohashi-n@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naro Ohashi |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Medicine
Zip code
Address
1-20-1 Handayama Higashi-ku Hamamatsu, 431-3192, Japan
TEL
053-435-2111
Homepage URL
ohashi-n@hama-med.ac.jp
Sponsor or person
Institute
First Department of Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
浜松医科大学病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Alogliptin improves steroid induced hyperglycemia by decrease of glucagon levels through an increase in plasma GLP-1 levels.
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
| 2011 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 06 | Day |
Last modified on
| 2014 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008268
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| Registered date | File name |
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| Registered date | File name |
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