UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039221 |
|---|---|
| Receipt number | R000044721 |
| Scientific Title | Comparison of the efficacy of insulin degludec/insulin aspart and insulin degludec/liraglutide in patients with type 2 diabetes |
| Date of disclosure of the study information | 2020/02/10 |
| Last modified on | 2021/08/10 11:42:10 |
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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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044721
