UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019096 |
|---|---|
| Receipt number | R000022011 |
| Scientific Title | Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agents |
| Date of disclosure of the study information | 2015/09/24 |
| Last modified on | 2019/05/10 23:54:42 |
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Basic information
Public title
Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agents
Acronym
Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agents
Scientific Title
Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agents
Scientific Title:Acronym
Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agents
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare efficacy and safety between dulaglutide and exenatide extended-release in type 2 diabetes mellitus patients who are controlled insufficiently with oral antidiabetic agents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of HbA1c,body weight at the 52th and the 104th week.
As for patients with renal disturbance, change of serum creatinine, urine albumin(mg/gCr), urine protein (g/gCr) at the 52th and the 104th week.
As for patients over 70 years old, change of MMSE at the 52th and the 104th week.
Key secondary outcomes
Change of data shown below at the 52th and the 104th week.
AST, ALT, gamma-GTP, LDL-C, HDL-C,TG, non-HOL-C, serum creatinine, serum UA, eGFR, 1,5-AG, self-monitoring blood glucose, Urine albumin(mg/gCr),Urine protein (g/gCr)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
From the start to the end of the study patients are treated with exenatide extended-release every week.
Interventions/Control_2
From the start to the end of the study patients are treated with dulaglutide every week.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HbA1c is higher than or equal to 6.5% or BMI is higher than or equal to 25.
Patients are not planned to be treated with prohibited combined drugs.
Key exclusion criteria
Type 1 diabetes mellitus patients.
Patients with a history of severe ketosis or diabetic coma in previous 6 months.
Patients with severe infection, before/after surgery or with severe traumatic injury.
Patients to have a plan to be pregnant.
Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis.
Patients with a history of pancreatitis.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Haga |
Organization
Haga Diabetes Clinic
Division name
Internal Medicine
Zip code
Address
3514-1 Teigaishinden Nishiho-cho Aisai Aichi Japan
TEL
0567-28-7700
tatsuya-umin@hagadm.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Haga |
Organization
Haga Diabetes Clinic
Division name
Internal Medicine
Zip code
Address
3514-1 Teigaishinden Nishiho-cho Aisai Aichi Japan
TEL
0567-28-7700
Homepage URL
tatsuya-umin@hagadm.com
Sponsor or person
Institute
Haga Diabetes Clinic
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
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
羽賀糖尿病内科（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 24 | 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
| 2015 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022011
