UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029743 |
|---|---|
| Receipt number | R000031750 |
| Scientific Title | Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors |
| Date of disclosure of the study information | 2017/10/29 |
| Last modified on | 2017/10/27 23:36:46 |
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Basic information
Public title
Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors
Acronym
Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors
Scientific Title
Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors
Scientific Title:Acronym
Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors
Region
| Japan |
Condition
Condition
Type 2 diabetes melltus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with the other DPP-4 inhibitors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HbA1c between the start and the fourth month and that between the fourth and the eighth month
Key secondary outcomes
Change in 1.5-AG, Urinary albumin (mg/gCr), and urinary protein (g/gCr) between the start and the fourth month and that between the fourth and the eighth month.
Number of patients who choose either medicine on the eighth month.
Change in HbA1c between the eighth and the 12th month.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
In the first period(for four months from the start), the former DPP-4 inhibitor is changed to trelagliptin 100mg, in the second period( for four months from the fifth month) trelagliptin is changed to omarigliptin 25mg. The necessity of reduction of the medicine is judged by attending doctors. Questionnaire is carried out at the end of the fourth month and the eight month. At the end of the eight month patients are asked to choose the next DPP-4 inhibitor from trelagliptin, omarigliptin, the former DPP-4 inhibitor. When patients are not able to make up their mind, attending doctors are able to give advices.
Interventions/Control_2
In the first period(for four months from the start), the former DPP-4 inhibitor is changed to omarigliptin 25mg, in the second period( for four months from the fifth month) omarigliptin is changed totrelagliptin 100mg. The necessity of reduction of the medicine is judged by attending doctors. Questionnaire is carried out at the end of the fourth month and the eight month. At the end of the eight month patients are asked to choose the next DPP-4 inhibitor from trelagliptin, omarigliptin, the former DPP-4 inhibitor. When patients are not able to make up their mind, attending doctors are able to give advices.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients who have been treated with once or twice daily DPP-4 inhibitors for more than three months.
Key exclusion criteria
Type 1 diabetic patients.
Patients with a history of severe ketosis or diabetic coma in previous 6 months.
Patients with severe infection, before/after surgery or severe traumatic injury.
Patients to have a plan to be pregnant.
Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis.
Patients with a history of pancreatitis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Haga |
Organization
Haga Diabetes Clinic
Division name
Internal Medicine
Zip code
Address
3514-1 Teigaishinden Nishiho-cho Aisai Aichi Japan
TEL
0567-28-7700
haga@fuga.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Haga |
Organization
Haga Diabetes Clinic
Division name
Internal Medicine
Zip code
Address
3514-1 Teigaishinden Nishiho-cho Aisai Aichi Japan
TEL
0567-28-7700
Homepage URL
haga@fuga.ocn.ne.jp
Sponsor or person
Institute
Haga Diabetes Clinic
Institute
Department
Personal name
Funding Source
Organization
Haga Diabetes Clinic
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
羽賀糖尿病内科
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 29 | 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
| 2015 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 27 | Day |
Last modified on
| 2017 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031750
