UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036788 |
|---|---|
| Receipt number | R000041798 |
| Scientific Title | An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients |
| Date of disclosure of the study information | 2019/05/18 |
| Last modified on | 2022/05/19 14:18:11 |
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Basic information
Public title
An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Acronym
An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Scientific Title
An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Scientific Title:Acronym
An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will investigate therapeutic efficacy when type 2 diabetes patients are switched from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HbA1c from before switching treatment to 24 weeks after switching
Key secondary outcomes
fasting blood glucose
2-h postprandial glucose
GA
insulin secretion capacity
pancreatic glucagon
flash glucose monitoring
Self-monitoring of blood glucose results
renal function
urinary albumin
L-FABP
Body weight
BMI
body composition
waist circumference
blood pressure
heart rate
lipids
UA
hepatic function
total protein
albumin
electrolytes
insulin dose
Evaluation of satisfaction with treatment
appetite
Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dulaglutitde group:
switch from intensive insulin therapy to long-acting insulin plus dulaglutide(0.75mg/week). The primary endpoint is the change in HbA1c level from immediately before switching treatments to 24 weeks later.
Interventions/Control_2
Empagliflozin group:
switch from intensive insulin therapy to long-acting insulin plus empagliflozin(10mg/day). The primary endpoint is the change in HbA1c level from immediately before switching treatments to 24 weeks later.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who have been undergoing treatment with intensive insulin therapy alone for or over12 weeks
2. Age or over 18 years and under 90 years
3. BMI under 45 kg/m2
4. Negative for anti-GAD antibodies
Key exclusion criteria
1. Patients with serious hepatic dysfunction
2. Patients with serious renal dysfunction
3. Patients taking steroids
4. Patients with cancer
5. Patients with severe infection or serious injury
6. Patients who are or could be pregnant
7. Patients with an allergy to the drug to be used or for whom it is contraindicated
8. Any other patients considered by the investigator or a subinvestigator to be unsuitable to participate in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Sato |
Organization
Chigasaki Municipal Hospital
Division name
Division of Endocrinology & Metabolism
Zip code
2530042
Address
5-15-1, Honson, Chigasaki, Kanagawa
TEL
0467-52-1111
shinobu@medical.email.ne.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Ito |
Organization
Chigasaki Municipal Hospital
Division name
Division of Endocrinology & Metabolism
Zip code
2530042
Address
5-15-1, Honson, Chigasaki, Kanagawa
TEL
0467-52-1111
Homepage URL
t186011a@yokohama-cu.ac.jp
Sponsor or person
Institute
Chigasaki Municipal Hospital
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
Chigasaki Municipal Hospital
Address
5-15-1, Honson, Chigasaki, Kanagawa
Tel
0467-52-1111
hosp_soumu@city.chigasaki.kanagawa.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
茅ヶ崎市立病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 18 | 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
| 2018 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 29 | 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 | 05 | Month | 18 | Day |
Last modified on
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041798
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
