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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000023914 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Type 2 diabetes mellitus | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Japan Community Healthcare Organization Kanazawa Hospital |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027439 |
Research Plan | |
Registered date | File name |
2017/09/05 | デュラグルチド研究計画書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データ.xlsx |