UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028763 |
|---|---|
| Receipt number | R000032901 |
| Scientific Title | The efficacy of teneligliptin in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2017/08/28 |
| Last modified on | 2019/02/24 14:44:35 |
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Basic information
Public title
The efficacy of teneligliptin in patients with type 2 diabetes mellitus
Acronym
The efficacy of teneligliptin in patients with type 2 diabetes mellitus
Scientific Title
The efficacy of teneligliptin in patients with type 2 diabetes mellitus
Scientific Title:Acronym
The efficacy of teneligliptin in patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy, the safety of teneligliptin switched from linagliptin in type2 diabetic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of change in HbA1c after administration 24 weeks later
Key secondary outcomes
Casual blood glucose, glycoalbumin
Serum lipid level(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol)
Urinary albumin, urinary L-FABP
The incidence of side effects
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with type 2 diabetes with HbA1c=> 7% at the time of consenting
2.Female and male patients over 20 years old
3.Patients have been taking daily linagliptin for more than 12 weeks
4.Patients who can provide their written consent for participation of this study
Key exclusion criteria
1.Patients with history of hypersensitivity to teneligliptin
2.Patients with diabetic ketoacidosis, diabetic coma, or bofore coma, type1 diabetes
3.Severe infection, before and not long after surgery, or patient with severe trauma
4.Women with during pregnancy , nursing, or pregnant likelihood
5.Patients with severe renal dysfunction ,end stage renal disease during dialysis
6.Patients with severe liver dysfunction
7.Inadequte patient judged by doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Koyano |
Organization
Juntendo University Urayasu Hospital
Division name
Endocrinology and Diabetology
Zip code
Address
2-1-1 Tomioka, Urayasu-city, Chiba 279-0021
TEL
047-353-3111
hkoyano@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Koyano |
Organization
Juntendo University Urayasu Hospital
Division name
Endocrinology and Diabetology
Zip code
Address
2-1-1 Tomioka, Urayasu-city, Chiba 279-0021
TEL
047-353-3111
Homepage URL
koyano@juntendo-urayasu.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
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
順天堂大学医学部附属浦安病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032901
