UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for renal outcomes with different combination therapies including Telmisartan in patients with type 2 diabetes and hypertension
Title of the study (Brief title)	Study for the effect of telmisartan on renal benefits in patients with type 2 diabetes and hypertension
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 compare the effect on microalbuminuria with three kinds of combination therapies, maximumdose of ARB, standarddose of ARB plus CCB, or standard dose of ARB plus diuretics, in patients with type 2 diabetes and hypertension
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Change in urine albumin excretion ratio
Key secondary outcomes	1) blood pressure, 2) HbA1c, plasma glucose, 3) uric acid, 4) urine sodium excretion radio

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	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Telmisartan
Interventions/Control_2	Telmisartan/ Hydrochlorothiazide
Interventions/Control_3	Telmisartan/ Amlodipine
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)patients with type 2 diabetes using standard dose of ARB, 2) urine albumin excretion ratio 30-300mg/gCr 3)systolic blood pressure 130-160mmHg 4) HbA1c < 8%(JDS), 5) lipid control is well controlled 6) written informed consent
Key exclusion criteria	1) severe hepatic dysfunction, renal dysfunction, heart failure, 2) history of anaphylaxis of Telmisartan, Hydrochlorothiazide or Amlodipine , 3) pregnancy, 4) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size	105

Research contact person
Name of lead principal investigator	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Email

Public contact
Name of contact person	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Homepage URL
Email	hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	北海道大学病院（北海道）、青木内科クリニック（北海道）、大通り内科クリニック（北海道）、小笠原クリニック札幌病院附属外来プラザ（北海道）、沖医院（北海道）、小野百合内科クリニック（北海道）、クラーク病院（北海道）、栗原内科（北海道）、桑園中央病院（北海道）、KKR札幌医療センター斗南病院（北海道）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 06 Month 27 Day
Last follow-up date	2016 Year 09 Month 03 Day
Date of closure to data entry	2016 Year 09 Month 03 Day
Date trial data considered complete	2016 Year 09 Month 03 Day
Date analysis concluded	2016 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 06 Month 28 Day
Last modified on	2017 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006930