UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of efficacy and safety of insulin glargine U-100/lixisenatide and insulin degludec/liraglutide in type 2 diabetes patients
Acronym	Comparison of efficacy and safety of insulin glargine U-100/lixisenatide and insulin degludec/liraglutide in type 2 diabetes patients
Scientific Title	Comparison of efficacy and safety of insulin glargine U-100/lixisenatide and insulin degludec/liraglutide in type 2 diabetes patients
Scientific Title:Acronym	Comparison of efficacy and safety of insulin glargine U-100/lixisenatide and insulin degludec/liraglutide in type 2 diabetes patients
Region	Japan

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

Objectives
Narrative objectives1	The purpose is to compare the efficacy of glycemic controland the safety of hypoglycemia between insulin glargine U-100/lixisenatide and insulin degludec/liraglutide .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of blood glucose level 70-180 mg/dl (time in range) in isCGM. The percentage of time when the blood glucose level is less than 70 mg/dl (time below range) in isCGM.
Key secondary outcomes	Changes in HbA1c levels Percentage of blood glucose levels above 180 mg/dl (time above range) in isCGM. Percentage of blood glucose levels below 54 mg/dl (severe hypoglycemia) in isCGM. Percentage of nocturnal hypoglycemic range (0: 00-5: 59, <70 mg/dl) in isCGM. Average blood glucose level in isCGM (24 hours, 0:00 to 6:00, 6:00 to 18:00, 18:00 to 24:00). As a blood glucose fluctuation index SD value (standard deviation of blood glucose fluctuation) (24 hours, 6: 00-18: 00) CV value (coefficient of variation of blood glucose) (24 hours, 6: 00-18: 00) Percentage of blood glucose levels 70-180 mg/dl (time in range) from 6:00 to 24:00. MODD (daily fluctuation) M value MAGE (mean amplitude of glycemic excursions) Degree of change in body weight Change in glycoalbumin Correlation between changes in CPI (serum c-peptide index) value and glycemic control index

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Insulin glargine U-100/lixisenatide combination injection for 20 weeks.
Interventions/Control_2	Insulin degludec/liraglutide combination injection for 20 weeks.
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	Patients who have been diagnosed with type 2 diabetes more than 1 year before the start of the study and have been treated with oral hypoglycemic agents for more than 6 months before the screening. Patients with HbA1c levels 7.0% or more and less than 11.0%.
Key exclusion criteria	Patients with gastrointestinal disorders such as gastroparesis and inflammatory bowel disease Patients with a history of pancreatitis The following patients or conditions that may cause hypoglycemia Gastrointestinal disorders such as diarrhea and vomiting Pituitary insufficiency or adrenal insufficiency Malnutrition, starvation, irregular dietary intake, lack of dietary intake or weakness Intense muscle exercise Excessive alcohol intake Patients with severe renal dysfunction (eGFR <30 mL/min/1.73 m2) or end-stage renal disease Patients with severe liver dysfunction (high AST or ALT of 100 U/L or more) Patients who have been treated with Insulin glargine U-100/lixisenatide or Insulin degludec/liraglutide in the past Pregnant or potentially pregnant women and lactating patients Other patients judged by the investigator to be inappropriate as subjects
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Yasuro Middle name Last name Kumeda
Organization	Minami Osaka Hospital
Division name	Internal Medicine
Zip code	5590012
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka 559-0012, Japan
TEL	0666860221
Email	y_kumeda@yahoo.co.jp

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	nothing
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	2022 Year 06 Month 02 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	Open public recruiting
Date of protocol fixation	2022 Year 04 Month 18 Day
Date of IRB	2022 Year 06 Month 02 Day
Anticipated trial start date	2022 Year 06 Month 03 Day
Last follow-up date	2023 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	2022 Year 04 Month 18 Day
Last modified on	2022 Year 07 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054185