UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024447 |
|---|---|
| Receipt number | R000027662 |
| Scientific Title | Verification of GLP-1 receptor agonist (Dulaglutide) additive effect on basal insulin therapy in patients with T2DM |
| Date of disclosure of the study information | 2016/10/17 |
| Last modified on | 2019/10/20 11:14:34 |
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Basic information
Public title
Verification of GLP-1 receptor agonist (Dulaglutide) additive effect on basal insulin therapy in patients with T2DM
Acronym
Verification of GLP-1 receptor agonist (Dulaglutide) additive effect on basal insulin therapy in patients with T2DM
Scientific Title
Verification of GLP-1 receptor agonist (Dulaglutide) additive effect on basal insulin therapy in patients with T2DM
Scientific Title:Acronym
Verification of GLP-1 receptor agonist (Dulaglutide) additive effect on basal insulin therapy in patients with T2DM
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Type 2 diabetes patients during treatment with basal insulin and the target , without changing the group to add administration of Dulaglutide insulin in dose loss by 50% , and the group to add administration of the Dulaglutide without changing the dose of insulin , the dose of insulin to randomly assigned to the group to add administration the Dulaglutide , the Dulaglutide administered for 24 weeks , to evaluate the efficacy and safety .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of hypoglycemia
Key secondary outcomes
The amount of change from baseline in HbA1c.
The amount of change from baseline in bodyweight.
The amount of change from the insulin dose of baseline.
Frequency of adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group to lose dose 50% insulin when add the Dulaglutide.
Interventions/Control_2
The group does not change the insulin dose when add the Dulaglutide.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The past three months , patients with type 2 diabetes are doing a basal insulin therapy with a fixed dose.
Patient HbA1c value of consent acquisition time of 6.5 to 10%.
Patient fasting serum CPR is greater than or equal to 0.5 ng / mL of consent acquisition point.
Patient age at the time of obtaining informed consent is 20 years of age or older.
Patients capable of obtaining the consent of the research participation by free will in writing from the person .
Key exclusion criteria
Type1 diabetes patients.
Patients receiving insulin other than basal insulin.
Patients who have used the GLP-1 receptor agonist in the past year.
Patients who have a history of pancreatitis.
During pregnancy , women who want to breast-feeding or during pregnancy .
Patients attending physician has determined that there is a clinical problem in order to participate in the study.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Kojima |
Organization
Japan Red Cross Medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
150-8935
Address
4-1-22 Hiroo Shibuya-ku Tokyo Japan
TEL
03-3400-1311
kojima_yuichi@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Omura |
Organization
Japan Red Cross Medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
150-8935
Address
4-1-22 Hiroo Shibuya-ku Tokyo Japan
TEL
03-3400-1311
Homepage URL
tks121@gmail.com
Sponsor or person
Institute
Japan Red Cross Medical Center
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
Japan Red Cross Medical Center
Address
4-1-22 Hiroo Shibuya-ku Tokyo Japan
Tel
03-3400-1311
chiken2@med.jrc.or.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
日本赤十字社医療センター（東京都）、むさし野ファミリークリニック（埼玉県）、目白内科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 17 | 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
48
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2016 | Year | 10 | Month | 17 | Day |
Last modified on
| 2019 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027662
