UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023243 |
|---|---|
| Receipt number | R000026431 |
| Scientific Title | Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease. |
| Date of disclosure of the study information | 2016/07/20 |
| Last modified on | 2025/03/06 19:25:53 |
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Basic information
Public title
Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease.
Acronym
Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease.
Scientific Title
Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease.
Scientific Title:Acronym
Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease.
Region
| Japan |
Condition
Condition
type2 diabetes meliitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patients with CKD and type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood glucose and HbA1c
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Distribution to a group as administration of sitagliptin 25mg for three months, followed by administration of teneligliptin 20mg for three months
Interventions/Control_2
Distribution to a group as administration of teneligliptin 20mg for three months, followed by administration of sitagliptin 25mg for three 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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
adult type 2 diabetes patients
Patients with renal function of eGFR 30~50ml/min/1.73m2, in oral teneligliptin 20mg
non insulin dependent state patients
patient's HbA1c are from 6 to 8 percent
Key exclusion criteria
Patients of both drugs is contraindicated
Pregnancy, patients in nursing
Patients suffering from a severe disease requiring hospitalization
Patients with anemia (Hb <10g / dl)
Patients undergoing steroid therapy
Patients attending physician was found to be inappropriate for any reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YASUO |
| Middle name | |
| Last name | ZENIMARU |
Organization
University of Fukui Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
910-1193
Address
23-3 Shimoaitsuki Matsuoka Eiheiji-cho Yoshida-gun Fukui Japan
TEL
0776-61-3111
zenimaru@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | YASUO |
| Middle name | |
| Last name | ZENIMARU |
Organization
University of Fukui Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
910-1193
Address
23-3 Shimoaitsuki Matsuoka Eiheiji-cho Yoshida-gun Fukui Japan
TEL
0776-61-3111
Homepage URL
zenimaru@u-fukui.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism University of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board, University of Fukui
Address
23-3 Shimoaitsuki Matsuoka Eiheiji-cho Yoshida-gun Fukui Japan
Tel
0776-61-8758
tokutei@ml.u-fukui.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
n.a.
Publication of results
Published
Result
URL related to results and publications
n.a.
Number of participants that the trial has enrolled
22
Results
The hypoglycemic effect obtained with 25 mg of sitagliptin was non-inferior to that of 20 mg of teneligliptin
Results date posted
| 2025 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were randomly assigned to two groups for the crossover study: the S group, which was first treated with T for 3 months and then switched to sitagliptin 25 mg (S) for 3 months, and the T group, which was treated with S for 3 months and then treated with T for 3 months.
Participant flow
Twelve patients were assigned to the sitagliptin group and 10 to the teneligliptin group, and all completed the study.
Adverse events
none in particular
Outcome measures
HbA1c
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026431
