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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007032
Receipt No. 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

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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
Email 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
Email ohashi-n@hama-med.ac.jp

Sponsor
Institute First Department of Medicine, Hamamatsu University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008268

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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