UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open label, randomized study for the comparison of effectiveness between glucagon-like peptide-1 (GLP-1) analogue in people with type 2 diabetes treated bolus first or basal first insulin therapy
Title of the study (Brief title)	An open label, randomized study for the comparison of effectiveness between glucagon-like peptide-1 (GLP-1) analogue in people with type 2 diabetes treated bolus first or basal first insulin therapy
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the multiple effects of GLP-1 analogue, such as insulin dose or blood glucose status to safely switch to GLP-1 analogue, vascular endothelial function, DTQS after treatment of insulin therapy in people with type2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	insulin dose to safely switch to GLP-1 analogue
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Liraglutide 0.9mg once a day for 6 months after treating fasting blood glucose with Bolus First(insulin glulisine)insulin therapy
Interventions/Control_2	Exenatide 10ug twice a day for 6 months after treating fasting blood glucose with Bolus First(insulin glulisine)insulin therapy
Interventions/Control_3	Liraglutide 0.9mg once a day for 6 months after treating fasting blood glucose with Basal First(insulin glargine)insulin therapy
Interventions/Control_4	Exenatide 10ug twice a day for 6 months after treating fasting blood glucose with Basal First(insulin glargine)insulin therapy
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 subjects must satisfy the following conditions: 1)Age at the time of obtaining informed consentis more than 20 years old 2) Patients with type 2 diabetes, whose HbA1c is more than 7.4% 3) Gender is unquestioned 4) Patients treated with Bolus First or Basal First insulin therapy
Key exclusion criteria	1.Hypersensitivity to components of liraglutide and exenatide 2.None Type 2 diabetes 3.Medical history and/or complication of diabetic ketoacidosis 4.Medical history and/or complication of severe hypoglycemia 5.Severe infection, around surgery or severe trauma 6.Patients who received the administration of DPP-4 inhibitors or GLP-1 analogue within 4 weeks 7.Treatment with glucocorticoid 8.Uncontrolled Hypertension(systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) 9.Proliferative retinopathy or maculopathy 10.History of malignancy 11.Severe health problems not suitable for the study 12.Pregnant or lactating woman 13.Cases that Physicians deem inappropriate as the target of the test
Target sample size	40

Research contact person
Name of lead principal investigator	TAKAMURA Toshinari
Organization	kanazawa University Graduate School of Medical Science.
Division name	Department of Disease control and homeostasis
Address	13-1 Takara-machi, kanazawa, Ishikawa, Japan
TEL	076-265-2710
Email	ttakamura@m-kanazawa.jp

Public contact
Name of contact person	TAKAMURA Toshinari
Organization	kanazawa University Graduate School of Medical Science.
Division name	kanazawa University Graduate School of Medical Science.
Address	13-1 Takara-machi, kanazawa, Ishikawa
TEL	076-265-2710
Homepage URL
Email	ttakamura@m-kanazawa.jp

Sponsor
Institute	Department of Disease Control and Homeostasis,kanazawa University Graduate School of Medical Science.
Institute
Department

Funding Source
Organization	Department of Disease Control and Homeostasis,kanazawa University Graduate School of Medical Science.
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

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 27 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 03 Month 29 Day
Last modified on	2018 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009865