UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes
Acronym	Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes
Scientific Title	Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes
Scientific Title:Acronym	Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes
Region	Japan

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

Objectives
Narrative objectives1	Compare the difference in glycemic control by treating patients with type 2 diabetes who need hospitalization for glycemic control with insulin degludec/insulin aspart (IDegAsp) and insulin degludec/liraglutide (IDegLira) .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of time of 3-day blood glucose 70-180 mg/dl (within target range), blood glucose 60 minutes, 90 minutes, and 120 minutes after each meal by using Flash Glucose Monitoring (FGM) for each treatment.
Key secondary outcomes	Percentage of time of 3-day blood glucose level less than 70 mg/dl (below target range), blood glucose level above 180 mg/dl (above target range), blood glucose level less than 54 mg/dl (severe hypoglycemic range), blood glucose level less than 70 mg/dl during night (0:00-6:00), The frequency of severe hypoglycemia (requiring the assistance of a third person, such as diabetic coma or precoma, convulsions), average blood glucose level, standard deviation value, coefficient of variation value, day to day variation, M-value, mean amplitude of glycemic excursions, C-peptide index pre and post-treatment, fasting blood glucose in early morning, Insulin degludec dose in each insulin-containing injection

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switching IDegLira after IDegAsp prior treatment
Interventions/Control_2	Switching IDegAsp after IDegLira prior treatment
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients who have been diagnosed with type 2 diabetes for more than 1 year before this study and have been treated with oral hypoglycemic drugs and/or long-acting insulin (excluding IDegAsp and IDegLira) for at least 6 months before screening. 2.Patients with glycated hemoglobin (HbA1c) levels of 7.0% or more and less than 11.0%.
Key exclusion criteria	1.Patients with a history of severe ketosis, diabetic coma or previous coma within 6 weeks of this study. 2.Patients with a history of severe hypoglycemia (diabetic coma or pre-coma and convulsions needing third person assistance) within 6 weeks of this study. 3.Patients with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 or serum creatinine 2.0mg/dL and more) or end-stage renal failure on dialysis. 4.Patients with proliferative retinopathy (however, patients who have undergone photocoagulation and have stable symptoms can be included). 5.Patients with a history of surgery for severe gastrointestinal disease. 6.Pregnant or possibly pregnant and lactating patients. 7.Patients with severe infections, before and after surgery, with severe trauma. 8.Patients receiving systemic corticosteroids. 9.Patients with severe liver dysfunction (high AST or ALT 100 U/L and more). 10.Patients with a history of allergy to the drug to be used in this study. 11.Patients with malignancy or a history of malignancy. 12.Patients judged by the investigator to be inappropriate as subjects.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Kawaguchi
Organization	Minami Osaka Hospital
Division name	Internal medicine
Zip code	5590012
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL	0666850221
Email	y.kawaguchi@minamiosaka.com

Public contact
Name of contact person	1st name Yuji Middle name Last name Kawaguchi
Organization	Minami Osaka Hospital
Division name	Internal medicine
Zip code	5590012
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL	0666850221
Homepage URL
Email	y.kawaguchi@minamiosaka.com

Sponsor
Institute	Minami Osaka Hospital
Institute
Department

Funding Source
Organization	Minami Osaka Hospital
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	Minami Osaka Hospital
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
Tel	0666850221
Email	y.kawaguchi@minamiosaka.com

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	2020 Year 02 Month 10 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	2020 Year 01 Month 21 Day
Date of IRB	2020 Year 02 Month 04 Day
Anticipated trial start date	2020 Year 02 Month 10 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 01 Month 21 Day
Last modified on	2021 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044721