UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047518 |
|---|---|
| Receipt number | R000054185 |
| Scientific Title | Comparison of efficacy and safety of insulin glargine U-100/lixisenatide and insulin degludec/liraglutide in type 2 diabetes patients |
| Date of disclosure of the study information | 2022/06/02 |
| Last modified on | 2022/07/30 10:08:13 |
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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
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
y.kawaguchi@minamiosaka.com
Sponsor or person
Institute
Minami Osaka Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054185
