UMIN-CTR Clinical Trial

Basic information
Public title	An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Acronym	An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Scientific Title	An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Scientific Title:Acronym	An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study will investigate therapeutic efficacy when type 2 diabetes patients are switched from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in HbA1c from before switching treatment to 24 weeks after switching
Key secondary outcomes	fasting blood glucose 2-h postprandial glucose GA insulin secretion capacity pancreatic glucagon flash glucose monitoring Self-monitoring of blood glucose results renal function urinary albumin L-FABP Body weight BMI body composition waist circumference blood pressure heart rate lipids UA hepatic function total protein albumin electrolytes insulin dose Evaluation of satisfaction with treatment appetite Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dulaglutitde group: switch from intensive insulin therapy to long-acting insulin plus dulaglutide(0.75mg/week). The primary endpoint is the change in HbA1c level from immediately before switching treatments to 24 weeks later.
Interventions/Control_2	Empagliflozin group: switch from intensive insulin therapy to long-acting insulin plus empagliflozin(10mg/day). The primary endpoint is the change in HbA1c level from immediately before switching treatments to 24 weeks later.
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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients who have been undergoing treatment with intensive insulin therapy alone for or over12 weeks 2. Age or over 18 years and under 90 years 3. BMI under 45 kg/m2 4. Negative for anti-GAD antibodies
Key exclusion criteria	1. Patients with serious hepatic dysfunction 2. Patients with serious renal dysfunction 3. Patients taking steroids 4. Patients with cancer 5. Patients with severe infection or serious injury 6. Patients who are or could be pregnant 7. Patients with an allergy to the drug to be used or for whom it is contraindicated 8. Any other patients considered by the investigator or a subinvestigator to be unsuitable to participate in the study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shinobu Middle name Last name Sato
Organization	Chigasaki Municipal Hospital
Division name	Division of Endocrinology & Metabolism
Zip code	2530042
Address	5-15-1, Honson, Chigasaki, Kanagawa
TEL	0467-52-1111
Email	shinobu@medical.email.ne.jp

Public contact
Name of contact person	1st name Kohei Middle name Last name Ito
Organization	Chigasaki Municipal Hospital
Division name	Division of Endocrinology & Metabolism
Zip code	2530042
Address	5-15-1, Honson, Chigasaki, Kanagawa
TEL	0467-52-1111
Homepage URL
Email	t186011a@yokohama-cu.ac.jp

Sponsor
Institute	Chigasaki Municipal Hospital
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	Chigasaki Municipal Hospital
Address	5-15-1, Honson, Chigasaki, Kanagawa
Tel	0467-52-1111
Email	hosp_soumu@city.chigasaki.kanagawa.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	茅ヶ崎市立病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 18 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	Completed
Date of protocol fixation	2018 Year 11 Month 29 Day
Date of IRB	2018 Year 11 Month 29 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2021 Year 11 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 18 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041798