UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038100 |
|---|---|
| Receipt number | R000043428 |
| Scientific Title | Safety and efficacy in the initiation of IDegLira for the outpatient with type 2 diabetes |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2022/07/06 09:18:28 |
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Basic information
Public title
Safety and efficacy in the initiation of IDegLira for the outpatient with type 2 diabetes
Acronym
IDegLira study
Scientific Title
Safety and efficacy in the initiation of IDegLira for the outpatient with type 2 diabetes
Scientific Title:Acronym
IDegLira study
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) in outpatient, to investigate the change from baseline in HbA1c, Glycoalbumin and exposure time of hypoglycemia after 8 weeks
Basic objectives2
Others
Basic objectives -Others
Safety, Efficacy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline in HbA1c, Glycoalbumin and exposure time of hypoglycemia after 8 weeks
Key secondary outcomes
Hypoglycemia
Exposure time of hypoglycemia by FGM during first 2 weeks and from 6 week to 8 week after initiation
Change in body weight
Insulin doses
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of IDegLira with Free Style Libre Pro to type 2 diabetes patients.
Doses will be adjusted in increments of 1 dose, aiming for a pre-breakfast selfmonitored
blood glucose (SMBG) target to 150mg/dl. Previous OHA will be continued without dose change except for DPPIV inhibitor. DPPIV inhibitor will be discontinued after administration of IDegLira.
Participants will wear twice after administration of IDegLira and before end of study during maximum 2weeks of each.
Intervention period will be for 8 weeks.
Interventions/Control_2
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 and Female
Key inclusion criteria
Type 2 diabetes patients who are uncontrolled one or over OHA treatment and are not treated insulin and GLP-1RA.
Key exclusion criteria
Sever impaired renal function.
(eGFR<30ml/min/1.73m2, end stage in CKD and dialysis)
Insulin depended stage (Fasting CPR <0.6 ng/ml)
Patients who are decided as inappropriate for other medical reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mizuho |
| Middle name | |
| Last name | Yamabe |
Organization
Murakami Memorial Hospital
Division name
Department of Internal Medicine
Zip code
722-0014
Address
1-14-26 shinhama,Onomichi-city Hiroshima Japan
TEL
0848-22-3131
mizuhoy@urban.ne.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Yamabe |
Organization
Murakami Memorial Hospital
Division name
Department of Internal Medicine
Zip code
722-0014
Address
1-14-26 shinhama Onomichi-city Hiroshima Japan
TEL
0848-22-3131
Homepage URL
http://www.murakami-kinen-hp.jp
mk-hp2@able.ocn.ne.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
none
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
Murakami Memorial Hospital
Address
1-14-26 shinhama Onomichi-city Hiroshima Japan
Tel
0848-22-3131
mizuhoy@urnan.ne.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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
JDS2020
Publication of results
Unpublished
Result
URL related to results and publications
JDS2020
Number of participants that the trial has enrolled
30
Results
Baseline age 57.7(year), sex(male,female)25/5,duration 9.3 (year), BMI28.1,
IdegLira was effective in reducing HbA1c (baseline 8.86, 4weeks 7.84 ,8weeks7.25) (%). GA (20.95,16.28, 15.73) (%), body weight (baseline 79.07, 8week 77.07(kg).
AST33.8,8weeks25.9, ALT48.9, 8weeks 31.7,GTP52.3,8week 34.3(IU/L). The mean percentage of time with less than 70 mg/dL measured by FGM was a tendency to increase a little at 8 weeks later compared with baseline.
Results date posted
| 2020 | Year | 07 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
type2 diabetes outpatients,Baseline age 57.7(year), sex (male/female) 30 (25/5),duration 9.37.96 (year), BMI28.1, HbA1c 8.86 (%)
Participant flow
type2 diabetes outpatients 30patients
Add on Ideglira 6dose
Adverse events
hypoglycemia
Outcome measures
HbA1c,GA,body weight
The mean percentage of time with less than70 mg/dL measured by FGM
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 05 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 07 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 25 | Day |
Last modified on
| 2022 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043428
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/07/05 | JDS2020定用抄録.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
