UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015811 |
|---|---|
| Receipt number | R000018395 |
| Scientific Title | Randomized controlled trial comparing the therapeutic effects and safety of alogliptin and linagliptin in type 2 diabetic patients associated with diabetic nephropathy |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2017/02/13 16:50:34 |
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Basic information
Public title
Randomized controlled trial comparing the therapeutic effects and safety of alogliptin and linagliptin in type 2 diabetic patients associated with diabetic nephropathy
Acronym
Comparion of alogliptin and linagliptin in type 2 diabetic patients associated with diabetic nephropathy
Scientific Title
Randomized controlled trial comparing the therapeutic effects and safety of alogliptin and linagliptin in type 2 diabetic patients associated with diabetic nephropathy
Scientific Title:Acronym
Comparion of alogliptin and linagliptin in type 2 diabetic patients associated with diabetic nephropathy
Region
| Japan |
Condition
Condition
type 2 diabetic patients associated with diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the therapeutic effects of alogliptin and linagliptin and safety by groups comparison method
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glycoalbumin
Key secondary outcomes
Hemoglobin A1c, 1,5-anhydroglucitol, adverse event
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
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of alogliptin 12.5mg(when eGFR between 21.5 to 35.7) or 6.25mg(when eGFR under 21.4) for 6 months
Interventions/Control_2
Administration of linagliptin 5mg for 6 months
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
type 2 diabetic patients with diabetic nephropathy treated without agents associated with incretin
Key exclusion criteria
1)Patients who has a history of hypersensitivity
2)Pregnant or possibly pregnant women and women on lactation
3)Ineligible patients according to the investigator's judgement
4)The patients who do not agree with this study
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimura Ryosuke |
Organization
Nagoya City West Medical Center
Division name
Endocrinology and Metabolism
Zip code
Address
1-1-1, Hirate-cho, Kita-ku, Nagoya, 462-8508 Japan
TEL
052-991-8121
r.kimura.21@west-med.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimura Ryosuke |
Organization
Nagoya City West Medical Center
Division name
Endocrinology and Metabolism
Zip code
Address
1-1-1, Hirate-cho, Kita-ku, Nagoya, 462-8508 Japan
TEL
052-991-8121
Homepage URL
r.kimura.21@west-med.jp
Sponsor or person
Institute
Nagoya City West Medical Center
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
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
| 2014 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 02 | 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
| 2014 | Year | 12 | Month | 01 | Day |
Last modified on
| 2017 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018395
