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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005253
Receipt No. R000006247
Scientific Title Effect of Metformin on the esRAGE levels in type 2 diabetic patients: the Metformin Sitagliptin Randomized Trial
Date of disclosure of the study information 2011/04/01
Last modified on 2015/03/16

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Basic information
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
Condition Type 2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
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

Intervention
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

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 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

Research contact person
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

Public contact
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

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

Funding Source
Organization None
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 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)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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 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
Other related information

Management information
Registered date
2011 Year 03 Month 15 Day
Last modified on
2015 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006247

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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