UMIN-CTR Clinical Trial

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
Last 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
Email	tatsuya-umin@hagadm.com

Public contact
1st 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
Email	tatsuya-umin@hagadm.com

Sponsor
Institute	Haga Diabetes Clinic
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022011