UMIN-CTR Clinical Trial

Basic information
Public title	Liraglutide Effect on Glucose Elevation and Nephropathy in Diabetes Study
Acronym	LEGEND Study
Scientific Title	Liraglutide Effect on Glucose Elevation and Nephropathy in Diabetes Study
Scientific Title:Acronym	LEGEND Study
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect on glucose control, weight and the renal function of GLP-1 analog liraglutide, for type 2 diabetic patients with nephropathy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate and amount of change of urinary microalbumin in the three-month average of 10, 11, and 12 months after from the start of treatment.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	GLP-1 analogue therapy: Liraglutide should be initiated with a dose of 0.3mg once daily and increased by 0.3 mg increments at interval of at least one week. The dosage should be appropriately adjusted according to the patient's condition; upper limit is 0.9mg.
Interventions/Control_2	Insulin therapy: The fine contents of medical treatment are not asked.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients with type 2 diabetes (6.2%<= HbA1c(NGSP)) taking with several OADs for more than 3 month treatments. 2.Patients with diabetic nephropathy.(30-1500 mg/g Cre) 3.Patients with the age between 20-75 years old 4.Sex: Unquestioned 5.Patients who agreed with the participation in this study with written consent
Key exclusion criteria	1. Diabetic coma, diabetic ketoacidosis and type 1 patients 2.Patients with the severe renal impairment.(Serum creatinine >=3.0mg/dl) 3.Patients with liver disfunction(ALT surpasses 3 times of normal upper limit) 4.Patient who has digestive trouble 5. In emergency cases such as severe infection and surgery 6.Patients with a history of lactic acidosis and pancreatitis 7.The patient who has the state of being easy to be accompanied by the patient and hypoxemia which have an advanced obstacle in cardiovascular systems, such as a shock, heart failure, myocardial infarction, and pulmonary embolism, and a pulmonary function. 8.Patient Who Has Dehydration 9.Alcoholic Excessive Ingestion Patient 10.Patient of Poor Nutritional Status, Starvation, Debility State, Hypophysis Malfunction, or Adrenal-Function Insufficiency 11.Pregnant Woman or Woman that May Have Become Pregnant 12.Insulin Preparation, GLP-1 Receptor Operation Medicine, Patient under DPP-4 Inhibitor Prescription 13.Patient Who Has Anamnesis of Hypersensitivity to Medicine of Ingredient of Research Medicine, or the Same Action Mechanism of the Research Medicine 14.Patient Whom Family Doctor Made Unsuitable to Research Participation from Medical Rationale
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ryoichi Takayanagi
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Bioregulatory Science
Zip code
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-5284
Email	ehirata11@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Eiichi Hayashida
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Bioregulatory Science
Zip code
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-5284
Homepage URL
Email	ehirata11@gmail.com

Sponsor
Institute	Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
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

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 31 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	2011 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date	2011 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 08 Month 23 Day
Last modified on	2015 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010228

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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