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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001887
Receipt No. R000002268
Scientific Title A prospective, time-series, multicenter study on the effect of telmisartan on intra-renal RAS in type 2 diabetes.
Date of disclosure of the study information 2009/04/14
Last modified on 2016/10/28

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Basic information
Public title A prospective, time-series, multicenter study on the effect of telmisartan on intra-renal RAS in type 2 diabetes.
Acronym Effect of telmisartan on intra-renal RAS in type 2 diabetes
Scientific Title A prospective, time-series, multicenter study on the effect of telmisartan on intra-renal RAS in type 2 diabetes.
Scientific Title:Acronym Effect of telmisartan on intra-renal RAS in type 2 diabetes
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of telmisartan on urinary AGT in type 2 diabetes patients
To clarify whether urinary AGT levels serve as a predictor for organ protection by ARB in type 2 diabetes patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1) AGT (urine and serum): 0, 6 and 12 months
2) Albumin (urine): 0, 6 and 12 months
Key secondary outcomes 1) BP: 0, 2, 4, 6, 8, 10 and 12 months
2) BW, BMI, waist circumference:0, 6 and 12 months
3) FBS, insulin, HbA1c: 0, 6 and 12 months
4) PRA, Aldosterone: 0 and 12 months
5) T-chol, LDL-chol, HDL-chol, TG: 0 and 12 months
6) Cr, BUN, UA: 0, 6 and 12 months
7) Cardiovascular events: 0-12 months
8) Insulin sensitivity: 0, 6 and 12 months
9) hsCRP: 0, 6 and 12 months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Telmisartan (20-80 mg/day, 12 months)
Interventions/Control_2
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) Diabetes mellitus
- FBS >= 126 mg/dL
- 75g OGTT (2 hours) >= 200 mg/dL
- PPG >= 200 mg/dL
2) Patients who have not been treated with an anti-hypertensive drug within 4 weeks
Key exclusion criteria 1) Type 1 diabetes mellitus
2) Pregnancy
3) Severe renal disease (CCr<30 mL/min, sCr >= 2.0 mg/dL)
4) Severe hepatic disease (GOT >= 150 IU or GPT >= 150 IU)
5) Endocrine disease
6) Patients with malignant tumor
7) Patients inadequate for the study
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Ishida
Organization Kagawa University, Faculty of Medicine
Division name Division of Hematology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL 087-891-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Hitomi
Organization Kagawa University, Faculty of Medicine
Division name Department of Pharmacology
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL 087-891-5111
Homepage URL
Email hitomi@kms.ac.jp

Sponsor
Institute Kagawa University, Faculty of 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

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 14 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
2009 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 06 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
2009 Year 04 Month 14 Day
Last modified on
2016 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002268

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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