UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000901
Receipt number R000000300
Scientific Title Optimal combination of pharmacological agents for cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance
Date of disclosure of the study information 2009/04/01
Last modified on 2020/10/19 09:30:51

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Basic information

Public title

Optimal combination of pharmacological agents for cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance

Acronym

Optimal combination of pharmacological agents for diabetic complications

Scientific Title

Optimal combination of pharmacological agents for cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance

Scientific Title:Acronym

Optimal combination of pharmacological agents for diabetic complications

Region

Japan


Condition

Condition

Cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance

Classification by specialty

Cardiology Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Prevention against cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance by a combination of statin and angiotensin receptor blocker in Japanese.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Impaired glucose tolerance, Insulin resistance; HOMA-R, Initial renal disease; Urinalysis for protein, Vascular disease; pulse wave velocity (PWV)

Key secondary outcomes

Blood pressure at rest, Pulse rate, Total cholesterol, Triglyceride, HDL cholesterol, Fasting plasma glucose (FPG), Hemoglobin A1c (HbA1c), Fasting serum insulin, Height, Weight, Body mass index(BMI), Echocardiography (IVSt, PWt, LVEDd, LVESd, Diastolic function; E/A ratio, Deceleration time), Electrocardiography at rest, Serum Creatinine, Urinalysis, Urine Creatinine, Urine Albumin, Intima-media thickness and plaque by carotid echography, Ankle-Brachial index(ABI), Total death count, Incidence of cardiovascular event, Incidence of discontinuance, Incidence of advers event


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

A water soluble statin (Pravastatin) for hyperlipidemia and antihypertensive agents except angiotensin receptor blockers (ARBs) and angiotensin converting enzyme inhibitors (ACEIs) such as Calcium (Ca) antagonists for hypertension for a year.

Interventions/Control_2

A water soluble statin (Pravastatin) for hyperlipidemia and an ARB (Losartan) for hypertension for a year.

Interventions/Control_3

A lipid soluble statin (Atorvastatin) for hyperlipidemia and antihypertensive agents except ARBs and ACEIs such as Ca antagonists for hypertension for a year.

Interventions/Control_4

A lipid soluble statin (Atorvastatin) for hyperlipidemia and an ARB (Losartan) for hypertension for a year.

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Positive findings from all of the following tests:
1) Positive findings from one of a)-d)

a) Impaired glucose tolerance; FPG from 110 to <126 mg/dl or 2hrPPG from 140 to <200 mg/dlorb)

b) HOMR-R(=FPG x Insulin level/405) >=1.73

c) HbA1c> 5.6

d) already taking any oral hypoglycemic drugs

2) B.P. at sitting position >=130/80 mmHg

3) LDL cholesterol level >=120 mg/dl

4) At least 3 months after the first instruction of diet therapy by a specialist

5) Not taking either statins or angiotensin receptor blocker for more than 3 momnths

6) Not applying to exceptions as below

Key exclusion criteria

1) Receiving insulin therapy

2) Having severe liver dysfunction or cirrhosis

3) Having severe renal dysfunction (Cre>=2.0) or under hemodialysis

4) Cerebrovascular disease within 3 months

5) Unstable angina, acute myocardial infarction, or severe coronary artery disease (left main trunk or 3-vessel disease)

6) Left ventricular dysfunction (LVEF<35%)

7) Not controlled hypertension (systolic BP>=180 mmHg with antihypertensive agents)

8) Not controlled hyperlipidemia (serum LDL level 180>=mmHg with antihyperlipidemic agents)

9) Having malignant tumor

10) Taking a steroid

11) Having allergy against these drugs

12) During pregnancy or the lactation period or having wish for pregnancy within a year

13) Regarded as unsuitable by the doctor in charge

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Hasegawa

Organization

Kyoto Medical Centar

Division name

Division of Translational Research

Zip code


Address

1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan

TEL

075-645-8401(-6132)

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiromichi Wada

Organization

Kyoto Medical Centar

Division name

Division of Translational Resaerch

Zip code


Address

1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan

TEL

075-645-8401(-8809)

Homepage URL


Email

hwada@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto Medical Centar

Institute

Department

Personal name



Funding Source

Organization

Japanese Government

Organization

Division

Category of Funding Organization

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 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000000300

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7266803/

Number of participants that the trial has enrolled

231

Results

LV mass and diastolic function were not affected after 1 year of metformin treatment in patients with T2DM. However, we observed benefits in terms of reductions in both BMI and LDL-C levels and preservation of renal function

Results date posted

2020 Year 10 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 06 Month 20 Day

Baseline Characteristics

Patients with T2DM with a history of hypertension

Participant flow

Patient Subjects were randomized 1:1 to treatment for 1 year with either metformin (metformin-treated group) or other hypoglycemic agents (control group).

Adverse events

Serious adverse events related with this intervention were not observed.

Outcome measures

The primary endpoints were changes in brain natriuretic peptide (BNP) levels, left ventricular (LV) mass index, and indicators of LV diastolic function. We also evaluated changes in both clinical findings and blood laboratory examination data.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2005 Year 07 Month 15 Day

Date of IRB


Anticipated trial start date

2005 Year 10 Month 01 Day

Last follow-up date

2009 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

2007 Year 11 Month 19 Day

Last modified on

2020 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000300


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name