UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of additive effects of dulaglutide and empagliflozin to type 2 diabetic patients with poor glycemic control despite insulin administration.
Title of the study (Brief title)	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	Yoshikazu Tamori
Organization	Social medical corporations Aijinkai Chibune hospital
Division name	Department of Endocrinology and diabetes
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	Hiroyuki Sato
Organization	Social medical corporations Aijinkai Chibune hospital
Division name	Department of Endocrinology and diabetes
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 10 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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