UMIN-CTR Clinical Trial

Public title

Effect of olmesartan on beta-cell function and diabetic angiopathy in type 2 diabeteic patients with hypertension

Acronym

beta-Function and Atherosclerosis by Olmesartan and Nateglinide

Scientific Title

Effect of olmesartan on beta-cell function and diabetic angiopathy in type 2 diabeteic patients with hypertension

Scientific Title:Acronym

beta-Function and Atherosclerosis by Olmesartan and Nateglinide

Region

Japan

Condition

diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to evaluate whether an ARB olmesartan would improve beta-cell function and prevent diabetic angiopathy in type 2 diabeteic patients with hypertension. We also examine whether treatment with olmesartan would affect the serum levels of the soluble form of RAGE.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary endpoints of the study were
1) Achievement rate of targeted blood pressure (<130/85mmHg) during a 24-week treatment period
2) Improvement rate of fasting blood glucose and HbA1c levels during a 24-week treatment period

Key secondary outcomes

The secondary endpoints were
1) Changes in the IMT value (mean and max IMT) during a 24-week treatment period measured by carotid arterial echography
2) Changes in the serum esRAGE levels during a 24-week treatment period
3) Changes in the insulin secretion and insulin resistance during a 24-week treatment period
4) Changes in the urinary albumin excretion rates during a 24-week treatment period

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Olmesartan treatment group (Group O);
Clinical investigators will initiate olmesartan (20mg/day) treatment following the allocation in the olmesartan treatment group. Treatment will be continued to achieve the target value specified in the hypertension treatment guidelines (<130/85 mmHg).

Interventions/Control_2

Amlodipine treatment group (Group A);
Clinical investigators will initiate amlodipine (5mg/day) treatment following the allocation in the amlodipine treatment group. Treatment will be continued to achieve the target value specified in the hypertension treatment guidelines (<130/85 mmHg).

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

30

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

Inclusion criteria
1) Type 2 diabetes patients (HbA1c (JDS value) below 8.0%) treated with dietary/exercise therapy and/or alpha-glucosidase inhibitors or nateglinide.
2) Having hypertension
3) aged 30 to 75 years of age at the time of enrollment (regardless of gender)
4) Written consent for participation in the study

Key exclusion criteria

Patients meeting one of the following conditions will be excluded:
1) unable to visit the outpatient clinics of diabetes periodically
2) diabetic retinopathy
3) advanced (&#8805; stage 4) diabetic nephropathy
4) severe hypertension (systolic blood pressure &#8805; 180 mmHg and/or diastolic blood pressure &#8805; 110 mmHg
5) diagnosed as having malignancy within 5 years
6) Judged as ineligible by clinical investigators

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Hideaki Kaneto

Organization

Osaka University Graduate School of Medicine

Division name

Department of Metabolic Medicine

Zip code

Address

2-2, Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Graduate School of Medicine

Division name

Department of Metabolic Medicine

Zip code

Address

2-2, Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

Homepage URL

Email

Institute

Department of Metabolic Medicine, Osaka University Graduate School of 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

松島医院（兵庫県）、児玉内科医院（兵庫県）、大歳内科（大阪府）、白岩医院（大阪府）、西淀病院内科（大阪府）

Date of disclosure of the study information

2011

Year

10

Month

25

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

Enrolling by invitation

Date of protocol fixation

2008

Year

06

Month

23

Day

Date of IRB

Anticipated trial start date

2008

Year

06

Month

01

Day

Last follow-up date

2012

Year

11

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

10

Month

25

Day

Last modified on

2011

Year

10

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007814