UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024703 |
|---|---|
| Receipt number | R000028421 |
| Scientific Title | Examination of additive effects of dulaglutide and empagliflozin to type 2 diabetic patients with poor glycemic control despite insulin administration. |
| Date of disclosure of the study information | 2016/11/04 |
| Last modified on | 2016/11/03 20:38:33 |
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Basic information
Public title
Examination of additive effects of dulaglutide and empagliflozin to type 2 diabetic patients with poor glycemic control despite insulin administration.
Acronym
Examination of additive effects of dulaglutide and empagliflozin to type 2 diabetic patients with poor glycemic control despite insulin administration.
Scientific Title
Examination of additive effects of dulaglutide and empagliflozin to type 2 diabetic patients with poor glycemic control despite insulin administration.
Scientific Title:Acronym
Examination of additive effects of dulaglutide and empagliflozin to type 2 diabetic patients with poor glycemic control despite insulin administration.
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 examine effects of SGLT2i and GLP-1 RA to glycemic metabolism,body weight,body fat of type 2 diabetic patients with poor glycemic control despite insulin administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c(%)
For patients of 65 years old and over,we follow HbA1c with causion to lower limit.
Key secondary outcomes
We assess body weight,accomplishment rates of HbA1c under 7%,blood pressure,renal function,and body fat.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of dulaglutide 0.75mg once a week for 24 weeks.
Interventions/Control_2
Administration of empagliflozin 10mg per day for 24 weeks.
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic outpatients in Chibune Hospital with HbA1c over 7.0% under 75 years old.
However,65 years old ond over,we select those with category 1 and HbA1c over 7.5%,and set treatment limits of HbA1c 6.5%.
Patients with informed concent to perticipate this study,who have never taken SGLT2i,DPP4i,GLP1RA.
Key exclusion criteria
Patients with 75 years old and over,category 2,3.
Patients who have not taken medicine for 3 months and over.
Patients with impaired liver or kidney functions,who need adjustment of medicine.Patients with collagen disease or cancer.Patients who have economic reasons,and judged not to be appropriate by doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Tamori |
Organization
Social medical corporations Aijinkai Chibune hospital
Division name
Department of Endocrinology and diabetes
Zip code
Address
2-2-45 tsukuda nishiyodogawa-Ku, Osaka, 551-0001, Japan
TEL
06-6471-9541
tamori@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Sato |
Organization
Social medical corporations Aijinkai Chibune hospital
Division name
Department of Endocrinology and diabetes
Zip code
Address
2-2-45 tsukuda nishiyodogawa-Ku, Osaka, 551-0001, Japan
TEL
06-6471-9541
Homepage URL
sato@med.kobe-u.ac.jp
Sponsor or person
Institute
Social medical corporations Aijinkai Chibune hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 | 11 | Month | 04 | 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
Date of protocol fixation
| 2016 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 03 | Day |
Last modified on
| 2016 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028421
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| Registered date | File name |
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