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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024447
Receipt No. 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 2018/08/25

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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 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Kojima
Organization Japan Red Cross Medical Center
Division name Department of Diabetes and Endocrinology
Zip code
Address 4-1-22 Hiroo Shibuya-ku Tokyo Japan
TEL 03-3400-1311
Email kojima_yuichi@med.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Omura
Organization Japan Red Cross Medical Center
Division name Department of Diabetes and Endocrinology
Zip code
Address 4-1-22 Hiroo Shibuya-ku Tokyo Japan
TEL 03-3400-1311
Homepage URL
Email tks121@gmail.com

Sponsor
Institute Japan Red Cross Medical Center
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2016 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2019 Year 08 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
2018 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027662

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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