UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026700 |
|---|---|
| Receipt number | R000030555 |
| Scientific Title | The efficacy of omarigliptin in type 2 diabetic patients |
| Date of disclosure of the study information | 2017/03/28 |
| Last modified on | 2019/09/26 16:41:42 |
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Basic information
Public title
The efficacy of omarigliptin in type 2 diabetic patients
Acronym
The efficacy of omarigliptin in type 2 diabetic patients
Scientific Title
The efficacy of omarigliptin in type 2 diabetic patients
Scientific Title:Acronym
The efficacy of omarigliptin in type 2 diabetic patients
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy, the safety and the effect on QOL of omarigliptin in type2 diabetic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change in postprandial plasma glucose, glycated albumin and HbA1c three months after administration of omarigliptin
Key secondary outcomes
1. Body wight, blood pressure, body composition
2. Serum C peptide
3. Incidence of adverse events
4. Incidence of hypoglycemia
5. Medication adherence, QOL
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.Naive cases for DPP-4 inhibitor
Patients with poor glycemic control on conventional therapy
2. Additional administration of omarigliptin
Patients with poor glycemic control with drug treatment except for DPP-4 inhibitor
3. Cases whose treatment is changed from other DPP-4 inhibitors
Criteria of poor glycemic control: HbA1c level exceeding 7.0% and/or glycated albumin level exceeding 21.0%
Key exclusion criteria
Patients having infectious diseases, thyroid disease, or malignant tumors.
Patients being treated with steroids and changing the dosage.
Patients considering not eligible for this trial by attending doctors due to any medical reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuriko |
| Middle name | |
| Last name | Izumi |
Organization
Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name
Department of Pharmacy
Zip code
770-8548
Address
1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL
088-631-0110
y.izumi@khg.or.jp
Public contact
Name of contact person
| 1st name | Machiko |
| Middle name | |
| Last name | Komatsu |
Organization
Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name
Department of diabetes mellitus
Zip code
770-8548
Address
1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL
088-631-0110
Homepage URL
machikomatsu@r7.dion.ne.jp
Sponsor or person
Institute
Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
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
Kawashima Hospital Ethics Review Committee
Address
1-1-39 Kitasako, Tokushima, 770-8548, Japan
Tel
088-631-0110
sasaka@khg.or.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
川島病院（徳島県）、川島透析クリニック（徳島県）、鴨島川島クリニック（徳島県）、鳴門川島クリニック（徳島県）、脇町川島クリニック（徳島県）、阿南川島クリニック（徳島県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | 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
41
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 | 03 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: case series study
Recruitment of target people:
All patients who consulted our facilities from March 2017 through March 2022 and meet the inclusion/exclusion criteria
Parameters:
Plasma glucose, glycated albumin, HbA1c, serum C peptide
Body weight, blood pressure, body composition
Medication adherence, QOL
Incidence of adverse events and hypoglycemia
Management information
Registered date
| 2017 | Year | 03 | Month | 25 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030555
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
