UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006278
Receipt number R000007430
Scientific Title Comparison of effectiveness of sitagliptin and nateglinide in type 2 diabetes.
Date of disclosure of the study information 2011/09/02
Last modified on 2011/09/02 16:40:29

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Basic information

Public title

Comparison of effectiveness of sitagliptin and nateglinide in type 2 diabetes.

Acronym

SiTagliptin AND nAteglinide RandomizeD clinical study (STANDARD Study)

Scientific Title

Comparison of effectiveness of sitagliptin and nateglinide in type 2 diabetes.

Scientific Title:Acronym

SiTagliptin AND nAteglinide RandomizeD clinical study (STANDARD Study)

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To comfirm the efficacy and safety of sitagliptin in comparison with nateglinide in type 2 diabetes whose glycemic control is insufficiet with diet and exercise therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c, Apo-B48, TG, glucose

Key secondary outcomes

GA, 1,5-AG, insulin, glucagon, adiponectin, Apo-A1, Apo-C3, Apo-B


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sitagliptin treatment, 3 months

Interventions/Control_2

Glinides treatment, 3 months

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients whose HbA1c level is more than 6.5% even after diet, excise.
1. The patients whose HbA1c are between 6.1 % and 8.0%.
2. The patients whose fasting glucose is less than 140 mg/dL.
3. The patients who have already started diet and exercise therapy for more than 3 months.
4. Patients who are more than 20 year-old.
5. No restriction on sex
6. The patients who are able to read and understand the written informed consent.

Key exclusion criteria

1.Contraindication for sitagliptin.
2.Contraindication for nateglinide.
3.Pregnant or possible pregnant.
4.Patients with sever liver failure or renal failure.
5.Patients considered not eligible for the study by the attending doctor due to other reasons.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichi Kojima

Organization

Japanese Red Cross Medical Center

Division name

Division of Diabetes and Endcrinolgy

Zip code


Address

4-1-22, hiro-o, shibuya-ku, tokyo 150-8935 JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Kojima

Organization

Japanese Red Cross Medical Center

Division name

Division of Diabetes and Endcrinolgy

Zip code


Address


TEL

03-3400-1311

Homepage URL


Email



Sponsor or person

Institute

Japanese Red Cross Medical Center

Institute

Department

Personal name



Funding Source

Organization

Japanese Red Cross Medical Center

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

2011 Year 09 Month 02 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

2010 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 02 Day

Last modified on

2011 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007430


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name