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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012171
Receipt No. R000014220
Scientific Title Exploratory study of DPP-4 inhibitor on glycemic control and organ protection in type2 diabetic patients
Date of disclosure of the study information 2013/10/30
Last modified on 2013/10/30

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Basic information
Public title Exploratory study of DPP-4 inhibitor on glycemic control and organ protection in type2 diabetic patients
Acronym Exploratory study of DPP-4 inhibitor on glycemic control and organ protection in type2 diabetic patients
Scientific Title Exploratory study of DPP-4 inhibitor on glycemic control and organ protection in type2 diabetic patients
Scientific Title:Acronym Exploratory study of DPP-4 inhibitor on glycemic control and organ protection in type2 diabetic patients
Region
Japan

Condition
Condition Type-2 diabetic patients (Type-2 diabetic patients with microalbuminuria or nephropathy)
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is an exploratory study of DPP-4 inhibitor aiming to evaluate the co-relationship between plasma glucose reduction and organ protection in type-2 diabetic patients wiht nephropathy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1)The change of HbA1c at baseline and 24 week after DPP-4 inhibitor treatment.
2)The change of UACR, L-FABP and plasma BNP at baseline and 24 week after DPP-4 inhibitor treatment.
3)The co-relationship between HbA1c reduction and the change of UACR, L-FABP and plasma BNP.
Key secondary outcomes 1)Echocardiography, CAVI
2)Fasting plasma glucose, plasma inflammatory markers
3)Body weight,Blood pressure,plasma lipid
4)Safety

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 Interventional

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 DPP-4 inhibitor (linagliptin)
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
30 years-old <=
Age-upper limit
74 years-old >
Gender Male and Female
Key inclusion criteria Type-2 diabetic patients who meet following criteria:
1)Type-2 diabetes millitus(HbA1c:6.5-8.5%)
2)Urinary albumin creatinin ratio(UACR):30-300mg/gCr
3)Age:30-74(Male and female)
4)Written informed consent are taken for the enrollement
Key exclusion criteria 1)Type-1 diabetes millius
2)Serum creatinin level of more than 1.2mg/dL in male patients and 1.0mg/dL in female patients
3)Diabetic ketosis, diabetic coma or total coma within 6 months
4)Severe infectious disease, before or after surgery, and severe trauma
5)Occurrence of ischemic stroke, hemorrhagic stroke or TIA within 6 months
6)Moderate or severe heart failure (NYHE 3 or 4)
7)Patients who receive other DPP4 inhibitors during 3 month before starting study
8)Under treatment with insulin
9)Pregnant, lactating, possibly pregnant or planning to become pregnant women
10)Past medical history of hypersensitivity to linagliptin
11)Patients considered as inadequate by the principal investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyoshi Tojo
Organization Tokyo Jikei University School of Medicine Kashiwa Hospital
Division name Department of Internal Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address 163-1 Kashiwashita, Kashiwa-city, Chiba Japan, 277-8567
TEL 0471-64-1111
Email tojo.k@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Maya Kano
Organization Tokyo Jikei University School of Medicine Kashiwa Hospital
Division name Department of Internal Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address 163-1 Kashiwashita, Kashiwa-city, Chiba Japan, 277-8567
TEL 0471-64-1111
Homepage URL
Email mayakichi@jikei.ac.jp

Sponsor
Institute Tokyo Jikei University School of Medicine Kashiwa Hospital
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 None
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 東京慈恵医科大学附属柏病院

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 30 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 Preinitiation
Date of protocol fixation
2013 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 30 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
2013 Year 10 Month 30 Day
Last modified on
2013 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014220


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