UMIN-CTR Clinical Trial

Public title

Effect of Metformin on the esRAGE levels in type 2 diabetic
patients: the Metformin Sitagliptin Randomized Trial

Acronym

METS trial

Scientific Title

Effect of Metformin on the esRAGE levels in type 2 diabetic
patients: the Metformin Sitagliptin Randomized Trial

Scientific Title:Acronym

METS trial

Region

Japan

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study is performed to clarify the effect of metformin on esRAGE levels of type 2 diabetic patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

esRAGE level of the plasma at 24 weeks after administration of metformin or sitagliptin.

Key secondary outcomes

sRAGE level of the plasma, pentosidine, HbA1C, FGP, BMI, TC, HDL, LDL, TG, ACR(Albumen Creatinine Ratio) 24 weeks after administration of metformin or sitagliptin.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

metformin is administrated and dosage will be increased appropriately to reach the target HbA1c level (6.5% JDS).

Interventions/Control_2

Sitagliptin is administrated and dosage will be increased appropriately to reach the target HbA1c level (6.5% JDS).

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 under life style intervention or mellitus taking an oral hypoglycemic agent except metformin, pioglitazone, DPP-4 inhibitor, GLP -1 analog preparation.
2)HbA1c >=6.5%, <=10.0%(JDS).
3)Age >=20 years, <75 years
4)Inpatient or outpatient.
5)Informed consent obtained

Key exclusion criteria

1)The use of oral hypoglycemic agents, insulin preparations adrenocorticosteroid within 12 weeks prior to the start of observation period.
2)Patients with severe ketosis, diabetic coma, or with precoma
3)Patients with severe infections, before or after operation, or with serious trauma.
4)AST, ALT <=2.5 x Upper limit of facility reference at most recent of the registration, or patients with hepatic cirrhosis.
5)Patients with renal impairment.(Diabetic nephropathy staging >=stage3B before registration.)
6)Serve cardiovascular or pulmonary disorders, including shock, heart failure, myocardial infarction, lung infarction etc., or other conditions that are apt to cause hypoxemia.
7) Patients suffering from malnutrition, inanition, debility, pituitary gland malfunction, or adrenal gland dysfunction.
8)History of lactic acidosis.
9)Patients with a malignant tumor treated now.
10)History of hypersensitivity to biguanide oral hypoglycemic agent or DPP-4 inhibitor.
11)Pregnant women or women suspected of being pregnant.
12)Other patients determined to be inappropriate by physician.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Shinya Fukumoto

Organization

Osaka City University Graduate School of Medicine

Division name

Metabolism, Endocrinology, and Molecular Medicine

Zip code

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan

TEL

06-6645-3806

Email

sfukumoto@med.osaka-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinya Fukumoto

Organization

Osaka City University Graduate School of Medicine

Division name

Metabolism, Endocrinology, and Molecular Medicine

Zip code

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan

TEL

06-6645-3806

Homepage URL

Email

sfukumoto@med.osaka-cu.ac.jp

Institute

Osaka City University Graduate School of Medicine,
Metabolism, Endocrinology, and Molecular Medicine

Institute

Department

Personal name

Organization

None

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

大阪市立大学医学部附属病院（大阪市）
大阪市立総合医療センター（大阪市）

Date of disclosure of the study information

2011

Year

04

Month

01

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

Terminated

Date of protocol fixation

2011

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

04

Month

01

Day

Last follow-up date

2014

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

03

Month

15

Day

Last modified on

2015

Year

03

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006247