UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022858 |
|---|---|
| Receipt number | R000026338 |
| Scientific Title | Investigation of satisfaction and efficacy after switching from daily DPP-4 inhibitors to weekly trelagliptin in patients with type 2 diabetes -prospective observational study- |
| Date of disclosure of the study information | 2016/06/24 |
| Last modified on | 2016/06/23 13:14:59 |
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Basic information
Public title
Investigation of satisfaction and efficacy after switching from daily DPP-4 inhibitors to weekly trelagliptin in patients with type 2 diabetes
-prospective observational study-
Acronym
Study for the satisfaction and efficacy of trelagliptin
Scientific Title
Investigation of satisfaction and efficacy after switching from daily DPP-4 inhibitors to weekly trelagliptin in patients with type 2 diabetes
-prospective observational study-
Scientific Title:Acronym
Study for the satisfaction and efficacy of trelagliptin
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of weekly DPP-4 inhibitor,on patients satisfaction and drug efficacy in patients with type 2 diabetes treating with daily DPP-4 inhibitors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
DTSQ(Diabetes Treatment Satisfaction Questionnaire)
Key secondary outcomes
DTR-QOL(Diabetes Therapy Related Quality of life)
HbA1c
Plasma glucose
Weight
Frequency of hypoglycemia
Stratified analysis(contributing factors, etc)using results of the questionnaire.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Keeping daily DPP-4 inhibitors
Interventions/Control_2
Switching from daily DPP-4 inhibitors to trelagliptin
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)Patients with type 2 diabetes who have been taking standard dose of daily DPP-4 inhibitors(Sitagliptin 50mg/Vildagliptin 100mg/Alogliptin 25mg/Linagliptin 5mg/Teneligliptin 20mg/Anagliptin 200mg/Saxagliptin 5mg)for more than 12 weeks.
2)Age:20 to 80 years old
3)The number of medication is less than six other than DPP-4 inhibitor
4)Written informed consent
Key exclusion criteria
1) Patient with malignant tumor
2)Pregnancy, nursing woman or possibly pregnant woman
3)Patients with severe infection, pre or post operation, severe trauma
4)Patients who are taking kinds of steroid
5)Patients with severe liver dysfunction(AST,ALT>100U/L)
6) Type 1 diabetes mellitus
7) Patients with hypersensitivity to study drugs on this study
8)Patients who can not do diet and exercise therapy
9)Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
北海道大学病院（北海道）、青木内科クリニック(北海道)、栗原内科（北海道）、萬田記念病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 20 | 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
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2016 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026338
