UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.
Title of the study (Brief title)	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	Saki Yamamoto
Organization	Showa University
Division name	Division of Diabetes,Metabolism and Endocrinology,Department
Address	1-5-8 Hatanodai,Sinagawa-ku,Tokyo,japan.
TEL	0337848000
Email	sakichakko@gmail.com

Public contact
Name of contact person	Saki Yamamoto
Organization	Showa University
Division name	Division of Diabetes,Metabolism and Endocrinology,Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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