UMIN-CTR Clinical Trial

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

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

08

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

08

Month

23

Day

Last modified on

2015

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010228