UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002978
Receipt number R000003614
Scientific Title The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor
Date of disclosure of the study information 2010/01/05
Last modified on 2017/01/10 16:55:12

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Basic information

Public title

The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor

Acronym

The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor

Scientific Title

The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor

Scientific Title:Acronym

The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To accurately evaluate insulin secretion, insulin resistance and beta cell function, and examine the effects of DPP-4 inhibitor sitagliptin on Japanese type 2 diabetes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Change in glycemic control (1 week after initiation of DPP-4 inhibitor therapy) (FPG, AUC PG during breakfast, 1,5-AG)

Key secondary outcomes

1.Change in insulin secretion (1 week after initiation of DPP-4 inhibitor therapy) (FIRI, Proinsulin/insulin ratio, HOMA-b, AUC IRI during breakfast)
2.Change in insulin sensitivity (1 week after initiation of DPP-4 inhibitor therapy) (HOMA-R)
3.Change in glucagon secretion (1 week after initiation of DPP-4 inhibitor therapy) ( FIRG, AUC IRG during breakfast


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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 (50mg/day)

Interventions/Control_2

sitagliptin (50mg/day)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.capable to be inserted catheters at three different site at both arms
2.capable to drink a bottle of liquid solution that corresponds to 75g glucose
3.capable to take a tablet of DPP-4 inhibitor

Key exclusion criteria

1.Patients with type 2 diabetes used either alpha-glucosidase inhibitors nor any insulin products
2.Patients who had allergy to DPP-4 inhibitor
3.Patients who had insulin allergy
4.type 1 diabetes
5.pancreatic diabetes
6.Patients who had anti-insulin antibodies
7.Serious liver or renal diseases
8.Other conditions precluding participation as judged by the investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Department of internal medicine, Kobe University Graduate School of medicine

Division name

Division of Diabetes, Metabolism and Endocrinology

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

078-382-5861

Email

kzhkskgc@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Department of internal medicine, Kobe University Graduate School of medicine

Division name

Division of Diabetes, Metabolism and Endocrinology

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

078-382-5861

Homepage URL


Email

kzhkskgc@med.kobe-u.ac.jp


Sponsor or person

Institute

Department of internal medicine, Kobe University Graduate School of medicine
Division of Diabetes, Metabolism and Endocrinology

Institute

Department

Personal name



Funding Source

Organization

entrusted accounting money

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

2010 Year 01 Month 05 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

Terminated

Date of protocol fixation

2010 Year 01 Month 05 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 06 Day

Last follow-up date

2015 Year 01 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 01 Month 05 Day

Last modified on

2017 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003614


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name