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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026700
Receipt No. 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 2017/03/25

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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
Middle name
Last name Yuriko Izumi
Organization Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name Department of Pharmacy
Zip code
Address 1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL 088-631-0110
Email y.izumi@khg.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Machiko Komatsu
Organization Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name Department of diabetes mellitus
Zip code
Address 1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL 088-631-0110
Homepage URL
Email machikomatsu@r7.dion.ne.jp

Sponsor
Institute Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Institute
Department

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
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 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 03 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 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
2017 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030555

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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