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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029743
Receipt No. 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

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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
Email 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
Email haga@fuga.ocn.ne.jp

Sponsor
Institute Haga Diabetes Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031750

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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