UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Jikei University School of Medicine Kashiwa Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京慈恵医科大学附属柏病院

Date of disclosure of the study information

2013

Year

10

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

10

Month

30

Day

Last modified on

2013

Year

10

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014220