UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023914 |
|---|---|
| Receipt number | R000027439 |
| Scientific Title | The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2018/09/04 11:18:29 |
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Basic information
Public title
The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus
Acronym
The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus
Scientific Title
The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus
Scientific Title:Acronym
The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigete the change on efficacy and safety associated with a switch from basal insulin to dulaglutide in patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of continuous glucose monitoring when switching from basal insulin to dulaglutide
Key secondary outcomes
HbA1c and body waight after 24 weeks,QOL wtih DTSQ,occurrence of hypoglycemia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We measure continuous glucose monitoring when switching basal insulin to dulaglutide. We measure the QOL of DTSQ at baseline of therapy with basal insulin and at after 24 weeks of therapy with dulaglutide.
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
The inclusion criteria were age => 20 years, diagnosis of type 2 diabetes, treatment with basal insulin for at least 24 weeks before entry into this study, and less than 1.0% HbAic change during the 24 weeks before entry into this study
Key exclusion criteria
1,Type 1 diabetes mellitus
2,Any patient who could not understand the device of ATEOS and DTSQ questionnaire
3,Any other condition which the attending physician feels would interfere with trial participation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mohiriho Okada |
Organization
Japan Community Healthcare Organization Kanazawa Hospital
Division name
Department of Pharmacy
Zip code
Address
Ha-15 Oki-machi, Kanazawa City, Ishikawa, Japan
TEL
076-252-2200
okada-knz@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mohiriho Okada |
Organization
Japan Community Healthcare Organization Kanazawa Hospital
Division name
Department of Pharmacy
Zip code
Address
Ha-15 Oki-machi, Kanazawa City, Ishikawa, Japan
TEL
076-252-2200
Homepage URL
okada-knz@umin.ac.jp
Sponsor or person
Institute
Japan Community Healthcare Organization Kanazawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Community Healthcare Organization Kanazawa Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 02 | Day |
Last modified on
| 2018 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027439
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/09/05 | ﾃﾞｭﾗｸﾞﾙﾁﾄﾞ研究計画書ver2正本.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/09/05 | Dulaglutide仕様書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/09/05 | Dulaglutideﾃﾞｰﾀ.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/27439
