UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012642
Receipt number R000014781
Scientific Title Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Date of disclosure of the study information 2013/12/21
Last modified on 2013/12/20 16:32:05

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Basic information

Public title

Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes

Acronym

Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes

Scientific Title

Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes

Scientific Title:Acronym

Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy of sitagliptin in type 2 diabetes;1)BS control, 2) side effect outbreak situation such as the hypoglycemia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of HbA1c

Key secondary outcomes

The change in
fasting blood glucose
Glycoalbumin (GA)
The weight
Glucagon
Insulin
C-peptide
Intact pro insulin(insulin/insulin ratio )


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

25mg of 50mg sitagliptin

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) The type 2 diabetes patient whom blood sugar control is inadequate for
2) 20 years old or older
3) Sex no object
4) Outpatient
5) The patient that a written agreement was provided

Key exclusion criteria

1)ketotic diabetic coma severe within the past six months or patient with the previous comatose past
2)Severe infectious disease, before and after operation, patient with a serious injury
3)pregnant woman or a woman with the possibility of the pregnancy and the patient whom I am nursing
4)Patient(more than less than creatinine clearance 50ml/min, serum creatinine man 1.5mg/dL more than woman 1.3mg/dL) having renal function disorder more than medium degree
5)Patient during insulin prescription
6)Patient during A-GI,drugs prescription
7)It is a patient with a history of the past of hypersensitivity for an ingredient of the study medicine
8)The patient whom the chief physician assumed inappropriateness for study articipation in planning from medical grounds

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuyoshi Namba

Organization

Hyogo College of Medicine

Division name

Division of Diabetes, Endocrinology & Metabolism

Zip code


Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6592

Email

ninai@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jyun-ichiro Miyagawa

Organization

Hyogo College of Medicine

Division name

Division of Diabetes, Endocrinology & Metabolism

Zip code


Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6592

Homepage URL


Email

miyagawa@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine,
Division of Diabetes, Endocrinology & Metabolism

Institute

Department

Personal name



Funding Source

Organization

Incretin Society in Hanshin

Organization

Division

Category of Funding Organization

Non profit foundation

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

2013 Year 12 Month 21 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

Enrolling by invitation

Date of protocol fixation

2010 Year 01 Month 23 Day

Date of IRB


Anticipated trial start date

2010 Year 02 Month 01 Day

Last follow-up date

2014 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 20 Day

Last modified on

2013 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014781


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name