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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012642
Receipt No. R000014781
Official scientific title of the study 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

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Basic information
Official scientific title of the study Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Title of the study (Brief title) 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 )

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Mitsuyoshi Namba
Organization Hyogo College of Medicine
Division name Division of Diabetes, Endocrinology & Metabolism
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6592
Email ninai@hyo-med.ac.jp

Public contact
Name of contact person Jyun-ichiro Miyagawa
Organization Hyogo College of Medicine
Division name Division of Diabetes, Endocrinology & Metabolism
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6592
Homepage URL
Email miyagawa@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine,
Division of Diabetes, Endocrinology & Metabolism
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2010 Year 01 Month 23 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014781


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