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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028313
Receipt No. R000032405
Scientific Title A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.
Date of disclosure of the study information 2017/07/25
Last modified on 2017/07/21

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Basic information
Public title A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.

Acronym A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.

Scientific Title A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.

Scientific Title:Acronym A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.

Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy for glucose lowering effect,body weight,frequency of the hypoglycemic onset,patients treatment satisfaction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change from baseline in HbA1c after 24 weeks of treatment.
Key secondary outcomes The change from baseline in bodyweight after 24 weeks of treatment.
DTSQs scale score(Diabetes Treatment Satisfaction Questionnaire)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Liraglutide-plus-basal-insulin combined therapy.
The antidiabetic agent allowed to combination in trial are metformin,pioglitazone, alpha glucosidase inhibitors.(It is only in case of use for more than 12weeks.)
The initial dose of liraglutide starts 0.3mg of subcutaneous injection a day and increases it in quantity with 0.6mg,0.9mg every week,while confirming a digestive symptom,should not exceed 0.9mg a day.
The dose of bolus insulin was reduced by one-of total bolus insulin dose at the time of liraglutide added in combination 0.3mg,0.6mg fourth,0.9mg.
Interventions/Control_2 Intensive insulin therapy.The antidiabetic agent allowed to combination in trial are metformin,pioglitazone,alpha glucosidase inhibitors.It is only in case of use for more than 12weeks.The adjustment of the insulin dose of the intensive insulin therapy assumes it the judgment of the investigator.

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.The subjects with HbA1c(NGSP)less than 10.0%.
2.The subjects with BMI more than 22kg/m2.
3.The subjects received in glucagon stimulation test for >3 months prior to trial screening,(more than CPR1.0ng/ml before test and also more than 2.0ng/ml after test,the subjects that there are few risks of hyperglycemia even if endogenous insulin secretion is kept and able to replaces bolus insulin with liraglutide.)
4.All subjects had been treated with intensive insulin therapy for >3 months,prior to trial screening.
5.Patients who can understand consent brief and other explanation documents having the ability of agreement about participation in this examination.
Key exclusion criteria 1.Patients with severe ketosis,diabetic coma,the former comatose or type 1 diabetes.
2.Patients with the serious infection,the perioperative period and the serious trauma.
3.Patients with severe renal dysfunction including the patients needing haemodialysis or peritoneal dialysis.
4.Patients with a history of hypersensitivity to liraglutide.
5.Patients with the pregnant woman or the woman who may be pregnant.
6.Patients with serious renal dysfunction,serious liver dysfunction,collagenous or a malignant tumor.
7.In addition,the patient who judged inappropriate by an attendant physician.
8.Patients who take dipeptide-peptidase4 inhibitor,sulfonylurea.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Saki Yamamoto
Organization Showa University
Division name Division of Diabetes,Metabolism and Endocrinology,Department
Zip code
Address 1-5-8 Hatanodai,Sinagawa-ku,Tokyo,japan.
TEL 0337848000
Email sakichakko@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Saki Yamamoto
Organization Showa University
Division name Division of Diabetes,Metabolism and Endocrinology,Department
Zip code
Address 1-5-8 Hatanodai,Sinagawa-ku,Tokyo,japan.
TEL 0337848000
Homepage URL
Email sakichakko@gmail.com

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Showa University school of medicine,Division of diabetes,metabolism
and endocrinology.
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 昭和大学付属東病院 Showa University higashi hospital

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 25 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
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
2016 Year 12 Month 01 Day
Date trial data considered complete
2016 Year 12 Month 01 Day
Date analysis concluded
2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 21 Day
Last modified on
2017 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032405

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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