UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041551 |
|---|---|
| Receipt number | R000047419 |
| Scientific Title | Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes |
| Date of disclosure of the study information | 2020/08/25 |
| Last modified on | 2021/08/26 09:34:03 |
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Basic information
Public title
Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes
Acronym
Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes
Scientific Title
Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes
Scientific Title:Acronym
Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy 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
Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes for hospitalization in a glycemic control.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy:Percentage of time of the glucose level of euglycemic area (70-179 mg/dl) of flash glucose monitoring (FGM).
safety:Percentage of time less than 70 mg/dl (low blood glucose area) of FGM.
Key secondary outcomes
The percentage of time of the glucose level of hyperglycemic area (180 mg/dl or more), severe hypoglycemic area (less than 54 mg/dl) and nighttime (0 : 00-5: 59) hypoglycemic area in FGM.
Mean blood glucose (24hours, 0:00-6:00, 6:00-18:00, 18:00-24:00), SD value(24hours, 6:00-18:00), CV value(24hours, 6:00-18:00), percentage of time of the glucose level of euglycemic area (70-179 mg/dl of FGM(6:00-24:00), daily variation , M value, MAGE, changes in glycoalbumin levels,period until target blood glucose level is reached and titration is completed.
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
combination of insulin glargine and lixisenatide + glulisine therapy
Interventions/Control_2
intensive insulin therapy
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 more than 1 year before the start of the study and who have been treated with oral hypoglycemic drugs for more than 6 months before the screening.
2.Patients with glycated hemoglobin (HbA1c) levels of 7.0% or more and less than 11.0%.
Key exclusion criteria
1. Patients with severe gastrointestinal disorders such as severe gastroparesis.
2. Patients with a history of pancreatitis.
3. Patients with a history of severe ketosis, diabetic coma or pre-coma within 6 weeks of starting the study.
4.Patients with severe hypoglycemia (diabetic coma or precoma, convulsion that requires the assistance of a third party) within 6 weeks of starting the study.
5. Patients with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 or serum creatinine level 2.0mg/dL or more) or patients with end-stage renal failure undergoing dialysis.
6. Patients with severe liver dysfunction (AST or ALT higher than 100U/L).
7. Patients with proliferative retinopathy (however, patients with stable symptoms who have undergone photocoagulation, etc. can be enrolled).
8. Pregnant or possibly pregnant women and lactating patients.
9. Patients with severe infections, serious injury before and after surgery.
10. Patients receiving systemic corticosteroids.
11. Patients with a history of allergies to the planned drug used in the study.
12. Patients with or history of malignancy.
13.Other patients who the investigator determined to be inappropriate as a subject.
Target sample size
20
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
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
y.kawaguchi@minamiosaka.com
Sponsor or person
Institute
Minami Osaka Hospital
Institute
Department
Personal name
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
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 | 08 | Month | 25 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 25 | Day |
Last modified on
| 2021 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047419
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| Registered date | File name |
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