UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory clinical trial about the efficacy and safety of GLP-1 receptor agonist dulaglutide in maintenance hemodialysis patients with type 2 diabetes treated with insulin
Acronym	An exploratory clinical trial about the efficacy and safety of GLP-1 receptor agonist dulaglutide in maintenance hemodialysis patients with type 2 diabetes treated with insulin
Scientific Title	An exploratory clinical trial about the efficacy and safety of GLP-1 receptor agonist dulaglutide in maintenance hemodialysis patients with type 2 diabetes treated with insulin
Scientific Title:Acronym	An exploratory clinical trial about the efficacy and safety of GLP-1 receptor agonist dulaglutide in maintenance hemodialysis patients with type 2 diabetes treated with insulin
Region	Japan

Condition
Condition	End-stage renal disease caused by type 2 diabetes
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of GLP-1 receptor agonist dulaglutide in maintenance hemodialysis patients with type 2 diabetes treated with insulin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The change in average blood glucose levels and glycemic variability evaluated by using continuous glucose monitoring (CGM) 2. The change in GA, HbA1c, and blood glucose 3. The change in insulin dose per day.
Key secondary outcomes	Secondary outcomes 1. The change in the scores of Development and Psychometric Validation of the Diabetes Therapy-Related QOL (DTR-QOL) Questionnaire 2. The change in body composition evaluated by using InBody 3. The change of blood glucose, GLP-1, GIP, and glucagon during hemodialysis treatment 4. The change in the interdialytic weight gain rate Safety outcomes 1. Frequency of serious adverse events associated with the use of dulaglutide 2. Frequency of hypoglycemia events associated with the use of dulaglutide

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Once-weekly administration of dulaglutide (0.75 mg) for 6 months.
Interventions/Control_2
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	1. Those undergoing maintenance hemodialysis for more than 6 months 2. Those, aged 20 or over, with type 2 diabetes treated with insulin 3. Those who had not been treated with DPP-4 inhibitors nor GLP-1 receptor agonists within 8 weeks just prior to starting this trial. 5. Those who have given written informed consent on the use of their clinical data for this trial
Key exclusion criteria	1. Those with hypersensitivity to DPP-4 inhibitors or GLP-1 receptor agonists 2. Those with serious diabetic ketosis, coma, or pre-coma 3. Those with severe active infection, serious trauma, or in the perioperative period 4. Those with severe heart or liver dysfunction 5. Those with problems shown as below: 1) Pituitary gland or adrenal gland dysfunction 2) In the status of impaired nutrition, starvation, irregular or insufficient dietary intake, or hyposthenia 3) Excessive muscular exercise 4) Heavy alcohol drinkers 6. BMI < 18.5 kg/m2 7. Those who are pregnant or beast-feeding, or those who might be pregnant 8. Those who are considered not eligible for this trial by attending doctors due to any medical reasons
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Akihiko Middle name Last name Saito
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Applied Molecular Medicine
Zip code	951-8520
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL	025-227-0915
Email	akisaito@med.niigata-u.ac.jp

Public contact
1st name of contact person	1st name Michihiro Middle name Last name Hosojima
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Clinical Nutrition Science
Zip code	951-8520
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL	025-368-9312
Homepage URL
Email	hoso9582@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University Graduate School of Medical and Dental Sciences Department of Applied Molecular Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shinrakuen Hospital Nagaoka Red Cross Hospital Nagaoka Chuo General Hospital Sado General Hospital Kido Hospital Niigata Saiseikai Sanjo Hospital Koyo Medical Clinic Maihira Clinic University of Niigata Prefecture Miura Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The institutional review boards of Niigata University
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
Tel	025-227-2006
Email	shomu@med.niigata-u.ac.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	新潟大学医歯学総合病院(新潟県)、信楽園病院(新潟県)、長岡赤十字病院(新潟県)、長岡中央総合病院(新潟県)、佐渡総合病院(新潟県)、木戸病院(新潟県)、 新潟県済生会三条病院(新潟県)、向陽メディカルクリニック(新潟県)、舞平クリニック(新潟県)、三浦内科医院(新潟県)

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 11 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	14
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	Completed
Date of protocol fixation	2016 Year 07 Month 11 Day
Date of IRB	2016 Year 06 Month 20 Day
Anticipated trial start date	2016 Year 10 Month 11 Day
Last follow-up date	2019 Year 03 Month 03 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 04 Day
Last modified on	2019 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027971