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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008758
Receipt No. R000010228
Scientific Title Liraglutide Effect on Glucose Elevation and Nephropathy in Diabetes Study
Date of disclosure of the study information 2012/08/31
Last modified on 2015/03/30

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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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