UMIN-CTR Clinical Trial

Public title

The effect on the renal functions and blood pressure of DPP-4 Inhibitor for the type 2 diabetic patients .

Acronym

Sitagliptin therapy for blood glucose ,BP,and renal function in type 2 diabetic patients.(STABAR)

Scientific Title

The effect on the renal functions and blood pressure of DPP-4 Inhibitor for the type 2 diabetic patients .

Scientific Title:Acronym

Sitagliptin therapy for blood glucose ,BP,and renal function in type 2 diabetic patients.(STABAR)

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect on glucose control, the blood-pressure and the renal functions of DPP-4 Inhibitor "Sitagliptin" for type 2 diabetic patients who are inadequately controlled blood glucose level.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change from baseline in HbA1c at Month 3.

Key secondary outcomes

1)Change for the following parameters between the baseline and the after 3, 6, 9 and 12 months..
1.blood pressure at the doctor's office-visit 2.blood pressure at home in the early morning 3.urinary micro-albumin level (creatinin equivalent)
4.eGFR 5.cystatin C 6.HbA1c(except the 3 months later) 7.casual blood glucose level 8.lipid level (HDL-C,LDL-C,TG) 9.hs-CRP 10.body weight
2)Change for 24-hour blood pressure between the baseline and after 6 and 12 months
3)Safety

Study type

Interventional

Basic design

Single arm

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Add-on Stagliptin (50mg ) for 12 months, after 3 months, the physician can increase the dose of Sitagliptin to 100mg or titlate the antidiabetic agent. In case of the patients with moderate renal impairment, the starting dose of Sitagliptin is 25mg, the physician may increase the maximum dose of 50 mg.

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Patients with type 2 diabetes (6.5%<=HbA1c<9.0%) who has suboptimal glycemic control by only with the diet and exercise therapy and or with anti-diabetic agents add-on with the diet and exercise therapy for more than 1 month treatments.
2)Patients with the age between 20-80 years old who agreed with the participation in this study with written consent.

Key exclusion criteria

1)Patients with type 1 diabetes
2)History of severe ketosis, diabetic coma or precoma within 6 months
3)Patients with severe infections, before or after operation, or with serious trauma
4)Ptientswho are pregnant, breast-feeding and/or intention to become pregnant
5)Patients with the severe renal impairment
6)Patients receiving Alfa-glycosidase inhibitor, Glinide or Insulin
7)Patients receiving DPP-4 inhibitor other than Sitagliptin
8)Patients having allergies against DPP-4 inhibitor or alfa-Glycosidase inhibitor
9)Patients determined to be inappropriate for the study by physician based on the scientific grounds.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Daisuke Koya

Organization

Kanazawa Medical University

Division name

Diadetes & Endocrinology

Zip code

Address

Daigaku1-1 Uchinadamachi Kahokugun Ishikawa

TEL

Email

Name of contact person

1st name
Middle name
Last name	Daisuke Koya

Organization

Kanazawa Medical University

Division name

Diadetes & Endocrinology

Zip code

Address

TEL

Homepage URL

Email

Institute

Kanazawa Medical University
Diadetes & Endocrinology

Institute

Department

Personal name

Organization

Kanazawa Medical University
Diadetes & Endocrinology

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

Date of disclosure of the study information

2011

Year

03

Month

29

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

Completed

Date of protocol fixation

2011

Year

01

Month

21

Day

Date of IRB

Anticipated trial start date

2011

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

03

Month

29

Day

Last modified on

2014

Year

08

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006137