UMIN-CTR Clinical Trial

Public title

Efficacy and safety of Liraglutide versus high-dose metformin as an initial treatment of type 2 diabetes; open label, randomized controlled trial

Acronym

Keio study for INitial treatment of type 2 Diabetes with Liraglutide versus Metformin: KIND-LM study

Scientific Title

Efficacy and safety of Liraglutide versus high-dose metformin as an initial treatment of type 2 diabetes; open label, randomized controlled trial

Scientific Title:Acronym

Keio study for INitial treatment of type 2 Diabetes with Liraglutide versus Metformin: KIND-LM study

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the efficacy and the safety of liraglutide and high-dose metformin in over-weight patients type 2 diabetes mellitus treated with monotherapy or combination therapy by alpha-glucosidase inhibitor and/or biganide

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

HbA1c level after 24 weeks of treatment

Key secondary outcomes

Percentage of patients achieving HbA1c target <6.5% or 7.0%(JDS)
Fasting plasma glucose
Body weight
Rate of hypoglycaemic episodes
Beta-cell function (HOMA-beta, proinsulin/insulin ratio)
Bio-markers for cardiovascular effects (PAI-1, hsCPR, BNP)
Bio-markers for oxidative stress (8-OH-dG, 8-isoprostane)
Patients QOL questionnaire

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

24-week treatment of liraglutide monotherapy

Interventions/Control_2

24-week treatment of high-dose metformin monotherapy

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 mellitus.
2. Informed consent obtained.
3. Age >=20 years, <75 years
4. Patients on diet/exercise therapy with or without OAD* monotherapy or combination therapy for no less than 3 months. (*OAD: alpha-glucosidase inhibitor or biganide)
5. Patients diagnosed as type 2 diabetes mellitus in ten years.
6. HbA1c >=6.5%, <9.0%(JDS).
7. BMI >=23.5kg/m2.
8. Patients able to come to hospital/clinic every bi-week.

Key exclusion criteria

1. Type 1 diabetes mellitus
2. No informed consent
3. Patients with allergic reaction
4. Pregnant, intention of becoming pregnant
5. Patients with history of lactic acidosis
6. Impaired hepatic function (AST>80IU/L or ALT>80IU/L), Impaired renal function [serum-creatinine;
>=1.3mg/dL(male),
>=1.2mg/dL(female)]
7. Patients with pre-proliferative retinopathy, or proliferative retinopathy
8. Patients with the gastrointestinal disorder, such as inflam-matory bowel disease and diabetic gastroparesis
9. Patients with history of pancreatitis
10. Patients with a personal history of medullary thyroid carcinoma (MTC) or those from families with known familial MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
11. Non compliance
12. Patients taking systemic corticosteroids
13. Previous liraglutide treatment
14. Any other condition which the attending physician feels would interfere with the study participation.

Target sample size

110

Name of lead principal investigator

1st name
Middle name
Last name	Yoshifumi Saisho

Organization

Keio University , School of Mecidicine

Division name

Department of Internal Medicine

Zip code

Address

35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo

TEL

03-5363-3797

Email

ysaisho@keio.jp

Name of contact person

1st name
Middle name
Last name	Yoshifumi Saisho

Organization

Keio University , School of Mecidicine

Division name

Department of Internal Medicine

Zip code

Address

35 Shinanomachi, Shinjuku-ku, 160-8582, Tokyo

TEL

03-5363-3797

Homepage URL

Email

ysaisho@keio.jp

Institute

Keio University , School of Mecidicine, Department of Internal Medicine

Institute

Department

Personal name

Organization

Novo Nordisk

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Saitama Social Insurance Hospital, Tokyo Dental College Ichikawa General Hospital, Kitasato Institute Hospital, etc.

Name of secondary funder(s)

None

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

慶應義塾大学病院（東京都）
埼玉社会保険病院（埼玉県）
横浜市民病院（神奈川県）
東京歯科大学市川総合病院（千葉県）
永寿総合病院（東京都）
立川病院（東京都）

Date of disclosure of the study information

2010

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2010

Year

08

Month

23

Day

Date of IRB

Anticipated trial start date

2010

Year

10

Month

01

Day

Last follow-up date

2012

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

09

Month

21

Day

Last modified on

2015

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005087