UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of degludec/liraglutide combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients
Acronym	Efficacy and safety of Xultophy combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients
Scientific Title	Efficacy and safety of degludec/liraglutide combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients
Scientific Title:Acronym	Efficacy and safety of Xultophy combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients
Region	Japan

Condition
Condition	Type 2 diabets
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate of the efficacy and safety of insulin degludec/liraglutide combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Comparing the two groups change in HbA1c over the 24-week treatment period
Key secondary outcomes	1. Fasting plasma glucose 2. Body weight 3. creatinine 4. eGFR 5. Urine albumin/creatinine ratio 6. Lipid profile 7. Insulin dose 8. Frequency of hypoglycemia 9. Other adverse event

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	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switching from basal insulin and 20mg/day teneligliptin to insulin degludec/liraglutide combination injection over 24 weeks. Basal insulin is titrated with the aim of achieving a fasting self-monitored blood glucose target of 80-130 mg/dL.
Interventions/Control_2	Switching from basal insulin and 20mg/day teneligliptin to basal insulin and 40mg/day teneligliptin over 24 weeks. Basal insulin is titrated with the aim of achieving a fasting self-monitored blood glucose target of 80-130 mg/dL.
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
Key inclusion criteria	1. Patients with type 2 diabetes ; age between 20 and 90 years 2. Patients with basal insulin and 20mg/day teneligliptin more than 8 weeks before intervention 3. Patients who showed HbA1c levels 7.0% to 11.0% 4. Patients without change of oral anti-diabetic medications over 8 weeks before intervention
Key exclusion criteria	1. Patients with insulin therapy except basal insulin 2. Patients with GLP-1 receptor agonist 3. Patients with severe liver dysfunction 4. Patients with severe infection, operation, trauma 5. Patients with steroid medication 6. Patient with erythropoietin therapy 7. Patients with malignant tumors 8. Patients who have pregnancy or possibilty of pregnancy, or are under lactation 9. Patients who have hypersensitivity to insulin degludec, liraglutide, or teneligliptin 10. Patients who are considered to be not eligible to the study by the doctor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tatsuro Middle name Last name Takano
Organization	Fujisawa City Hospital
Division name	Department of Diabetology and Endocrinology
Zip code	251-8550
Address	2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
TEL	0466-25-3111
Email	takanot460121@yahoo.co.jp

Public contact
Name of contact person	1st name Shunsuke Middle name Last name Yamazaki
Organization	Fujisawa City Hospital
Division name	Department of Diabetology and Endocrinology
Zip code	251-8550
Address	2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
TEL	0466-25-3111
Homepage URL
Email	yamazaki-s@umin.ac.jp

Sponsor
Institute	Fujisawa City 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)

IRB Contact (For public release)
Organization	Fujisawa City Hospital
Address	2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
Tel	0466-25-3111
Email	yamazaki-s@umin.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

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 23 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	Terminated
Date of protocol fixation	2019 Year 11 Month 19 Day
Date of IRB	2019 Year 11 Month 19 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2022 Year 12 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	2019 Year 11 Month 23 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044067