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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024703
Receipt No. 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

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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
Email 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
Email sato@med.kobe-u.ac.jp

Sponsor
Institute Social medical corporations Aijinkai Chibune hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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