UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019975 |
|---|---|
| Receipt number | R000023064 |
| Scientific Title | The efficacy of dulaglutide in diabetic patients |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2017/12/01 14:20:03 |
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Basic information
Public title
The efficacy of dulaglutide in diabetic patients
Acronym
The efficacy of dulaglutide in diabetic patients
Scientific Title
The efficacy of dulaglutide in diabetic patients
Scientific Title:Acronym
The efficacy of dulaglutide in diabetic patients
Region
| Japan |
Condition
Condition
Type2 diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and the safety of dulaglutide in type2 diabetic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The primary end-point is plasma glucose, glycated albumin or HbA1c measurement twelve weeks after new, additional administration of dulaglutide and change from other GLP-1 receptor agonist in type 2 diabetic patients.
Key secondary outcomes
Other laboratory data and adverse events will be analyzed as well.
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) Fresh cases for GLP-1 receptor agonist: Patients with poor glycemic control after two months on dietary and exercise therapy
2) Supplementation case for GLP-1 receptor agonist: Patients with poor glycemic control on treatment with antidiabetic agents except GLP-1 receptor agonist
3) Cases whose treatment is changed from other GLP-1 receptor agonist
4) The 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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Machiko Komatsu |
Organization
Kawashima Hospital
Division name
Department of diabetes mellitus
Zip code
Address
1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL
088-631-0110
machikomatsu@r7.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Miyajima |
Organization
Kawashima Hospital
Division name
The general affairs division
Zip code
Address
1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL
088-631-0110
Homepage URL
a.miyajima@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
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）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | 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 | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | 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 in from December 2015 through December 2018 and meet the inclusion/exclusion criteria
Parameters: plasma glucose, glycated albumin or HbA1c measurement
Management information
Registered date
| 2015 | Year | 11 | Month | 28 | Day |
Last modified on
| 2017 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023064
