UMIN-CTR Clinical Trial

Basic information
Public title	Verification of GLP-1 receptor agonist (Dulaglutide) additive effect on basal insulin therapy in patients with T2DM
Acronym	Verification of GLP-1 receptor agonist (Dulaglutide) additive effect on basal insulin therapy in patients with T2DM
Scientific Title	Verification of GLP-1 receptor agonist (Dulaglutide) additive effect on basal insulin therapy in patients with T2DM
Scientific Title:Acronym	Verification of GLP-1 receptor agonist (Dulaglutide) additive effect on basal insulin therapy in patients with T2DM
Region	Japan

Condition
Condition	Type2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Type 2 diabetes patients during treatment with basal insulin and the target , without changing the group to add administration of Dulaglutide insulin in dose loss by 50% , and the group to add administration of the Dulaglutide without changing the dose of insulin , the dose of insulin to randomly assigned to the group to add administration the Dulaglutide , the Dulaglutide administered for 24 weeks , to evaluate the efficacy and safety .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of hypoglycemia
Key secondary outcomes	The amount of change from baseline in HbA1c. The amount of change from baseline in bodyweight. The amount of change from the insulin dose of baseline. Frequency of adverse events.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group to lose dose 50% insulin when add the Dulaglutide.
Interventions/Control_2	The group does not change the insulin dose when add the Dulaglutide.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The past three months , patients with type 2 diabetes are doing a basal insulin therapy with a fixed dose. Patient HbA1c value of consent acquisition time of 6.5 to 10%. Patient fasting serum CPR is greater than or equal to 0.5 ng / mL of consent acquisition point. Patient age at the time of obtaining informed consent is 20 years of age or older. Patients capable of obtaining the consent of the research participation by free will in writing from the person .
Key exclusion criteria	Type1 diabetes patients. Patients receiving insulin other than basal insulin. Patients who have used the GLP-1 receptor agonist in the past year. Patients who have a history of pancreatitis. During pregnancy , women who want to breast-feeding or during pregnancy . Patients attending physician has determined that there is a clinical problem in order to participate in the study.
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Kojima
Organization	Japan Red Cross Medical Center
Division name	Department of Diabetes and Endocrinology
Zip code	150-8935
Address	4-1-22 Hiroo Shibuya-ku Tokyo Japan
TEL	03-3400-1311
Email	kojima_yuichi@med.jrc.or.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Omura
Organization	Japan Red Cross Medical Center
Division name	Department of Diabetes and Endocrinology
Zip code	150-8935
Address	4-1-22 Hiroo Shibuya-ku Tokyo Japan
TEL	03-3400-1311
Homepage URL
Email	tks121@gmail.com

Sponsor
Institute	Japan Red Cross Medical Center
Institute
Department

Funding Source
Organization	None
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	Japan Red Cross Medical Center
Address	4-1-22 Hiroo Shibuya-ku Tokyo Japan
Tel	03-3400-1311
Email	chiken2@med.jrc.or.jp

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	日本赤十字社医療センター（東京都）、むさし野ファミリークリニック（埼玉県）、目白内科クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 17 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	48
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	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 06 Day
Date of IRB	2019 Year 09 Month 30 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 17 Day
Last modified on	2019 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027662