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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005115
Receipt No. R000006080
Scientific Title An Open label multi- facilities cooperation randomized control trial to verify methylglyoxal reductive effects of sitagliptin treatment in the type 2 diabetic patients.
Date of disclosure of the study information 2011/05/01
Last modified on 2019/01/11

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Basic information
Public title An Open label multi- facilities cooperation randomized control trial to verify methylglyoxal reductive effects of sitagliptin treatment in the type 2 diabetic patients.
Acronym Sitagliptin reduces the plasma methylglyoxal levels in poorly controlled type 2 diabetic patients.
Scientific Title An Open label multi- facilities cooperation randomized control trial to verify methylglyoxal reductive effects of sitagliptin treatment in the type 2 diabetic patients.
Scientific Title:Acronym Sitagliptin reduces the plasma methylglyoxal levels in poorly controlled type 2 diabetic patients.
Region
Japan

Condition
Condition Poorly controlled type 2 diabetic patients.
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate whether sitagliptin reduces the plasma methylglyoxal levels more than other oral hypoglycemic agents in poorly controlled type 2 diabetic patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes percent change of plasma methylglyoxal level.
Key secondary outcomes Percent changes in blood pressure, HbA1c, the urinary excretions of albumin, MCP-1, 8-OHdG and AGT.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 This study is a prospective randomized control trial. The entry period of this study is three years. Study subjects are poorly controlled type 2 diabetic patients. These patients are randomly assigned to two groups, an sitagliptin treatment group (sitagliptin 25mg/day) and other oral hypoglycemic agents treatment group. The dose of sitagliptin can be properly increased to 100 mg/day when the hypoglycemic effect is insufficient.
Interventions/Control_2 Their height, body weight, blood pressure, serum creatinine, plasma methylglyoxal levels, urinary excretions of albumin, MCP-1, 8-OHdG, and AGT are determined before (baseline) and after the treatment for three months. We collect fasting blood and first urine samples in early morning.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The subjects enrolled in the present study are poorly glycemic controlled out-patients with type 2 diabetes mellitus, who fulfill the following criteria; 1) poorly glycemic controlled defined as the HbA1c of more than 6.0%. 2) The medicine is not changed within the last three months, and the change of the medicine is not scheduled for the examination period (three months). 3) Serum creatinine is less than 2.5 mg/dl. 4) The participation agreement of this study is obtained.
Key exclusion criteria 1) The participation agreement of this study is not obtained.
2) To have other serious and active diseases such as severe hypertension, liver dysfunction, cardiovascular disease and so on.
3) Corresponding to the serum creatinine level > 2.5 mg/dl, or receiving continuous dialysis).
4) Woman who has pregnancy or possibility of pregnancy and suckling.
5) The patient that corresponds to contraindication of siutagliptin treatment.
6) Severe hyperglycemic subjects (HbA1c>10%). (It is necessary to do the insulin treatment.)
7) Patient from whom physician in charge of treatment judged this study participation to be improper.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Ogawa MD,PhD
Organization Tohoku University Hospital
Division name Division of Nephrology, Endocrinology and Hypertension
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7166
Email

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Ogawa MD,PhD
Organization Tohoku University Hospital
Division name Division of Nephrology, Endocrinology and Hypertension
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7166
Homepage URL
Email ogawa-s@hosp.tohoku.ac.jp

Sponsor
Institute Graduate School of Medicine, Tohoku University
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

Other administrative information
Date of disclosure of the study information
2011 Year 05 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 Completed
Date of protocol fixation
2011 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 08 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 21 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006080

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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