UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038667 |
|---|---|
| Receipt number | R000044067 |
| Scientific Title | Efficacy and safety of degludec/liraglutide combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients |
| Date of disclosure of the study information | 2019/11/23 |
| Last modified on | 2020/06/01 12:43:51 |
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Basic information
Public title
Efficacy and safety of degludec/liraglutide combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients
Acronym
Efficacy and safety of Xultophy combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients
Scientific Title
Efficacy and safety of degludec/liraglutide combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients
Scientific Title:Acronym
Efficacy and safety of Xultophy combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients
Region
| Japan |
Condition
Condition
Type 2 diabets
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate of the efficacy and safety of insulin degludec/liraglutide combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Comparing the two groups change in HbA1c over the 24-week treatment period
Key secondary outcomes
1. Fasting plasma glucose
2. Body weight
3. creatinine
4. eGFR
5. Urine albumin/creatinine ratio
6. Lipid profile
7. Insulin dose
8. Frequency of hypoglycemia
9. Other adverse event
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
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from basal insulin and 20mg/day teneligliptin to insulin degludec/liraglutide combination injection over 24 weeks. Basal insulin is titrated with the aim of achieving a fasting self-monitored blood glucose target of 80-130 mg/dL.
Interventions/Control_2
Switching from basal insulin and 20mg/day teneligliptin to basal insulin and 40mg/day teneligliptin over 24 weeks. Basal insulin is titrated with the aim of achieving a fasting self-monitored blood glucose target of 80-130 mg/dL.
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
1. Patients with type 2 diabetes ; age between 20 and 90 years
2. Patients with basal insulin and 20mg/day teneligliptin more than 8 weeks before intervention
3. Patients who showed HbA1c levels 7.0% to 11.0%
4. Patients without change of oral anti-diabetic medications over 8 weeks before intervention
Key exclusion criteria
1. Patients with insulin therapy except basal insulin
2. Patients with GLP-1 receptor agonist
3. Patients with severe liver dysfunction
4. Patients with severe infection, operation, trauma
5. Patients with steroid medication
6. Patient with erythropoietin therapy
7. Patients with malignant tumors
8. Patients who have pregnancy or possibilty of pregnancy, or are under lactation
9. Patients who have hypersensitivity to insulin degludec, liraglutide, or teneligliptin
10. Patients who are considered to be not eligible to the study by the doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Takano |
Organization
Fujisawa City Hospital
Division name
Department of Diabetology and Endocrinology
Zip code
251-8550
Address
2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
TEL
0466-25-3111
takanot460121@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Yamazaki |
Organization
Fujisawa City Hospital
Division name
Department of Diabetology and Endocrinology
Zip code
251-8550
Address
2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
TEL
0466-25-3111
Homepage URL
yamazaki-s@umin.ac.jp
Sponsor or person
Institute
Fujisawa City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujisawa City Hospital
Address
2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
Tel
0466-25-3111
yamazaki-s@umin.ac.jp
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
| 2019 | Year | 11 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2019 | Year | 11 | Month | 23 | Day |
Last modified on
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044067
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