UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006470
Receipt number R000007677
Scientific Title Effect of DPP-4 inhibitor on insulin therapy for patients with type 2 diabetes
Date of disclosure of the study information 2011/12/05
Last modified on 2014/06/12 11:03:50

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Basic information

Public title

Effect of DPP-4 inhibitor on insulin therapy for patients with type 2 diabetes

Acronym

Dpp-4 Inhibitor And Basal insulin-Therapy (DIAB-therapy)

Scientific Title

Effect of DPP-4 inhibitor on insulin therapy for patients with type 2 diabetes

Scientific Title:Acronym

Dpp-4 Inhibitor And Basal insulin-Therapy (DIAB-therapy)

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The study aims to examine effects on glucose metabolism and its related factors (glucagon, C-peptide) with DPP-4 inhibitor "Sitagliptin" for patients with type 2 diabetes who are inadequately controlled blood glucose level treated by insulin mono-therapy or insulin combined with metformin, SU or pioglitazone therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in responses of glucose, glucagon and C-peptide with sitagliptin treatment examined by OGTT

Key secondary outcomes

Change of HbA1c, fasting plasma glucose, glucagon and C-peptide before and after sitagliptin treatment


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

Sitaglipitin

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)Patients with type 2 diabetes who is treated by insulin mono-therapy or insulin and insulin combined with metformin, SU or pioglitazone therapy.
2)HbA1c >=7.5%, <10.0% JDS
3)Age >=20 years (Male and Female)

Key exclusion criteria

1)Patients with type 1diabetes (fasting C-peptide less than 0.5mg/dL)
2)Patients with severe ketosis, diabetic coma or precoma within 6 months
3)Patients with severe infections, before or after operation, or serious trauma .
4)Patients with exceeding the moderate renal impairment (sCr: male>=1.5mg/dl, female>=1.3mg/dl).
5)Patients receiving GLP-1 analog
6)Patients receiving oral glucose lowering drug without metformin, SU or pioglitazone
7)Patients who are pregnant, breast-feeding and/or intention to become pregnant
8)Patients with allergy against sitagliptin
9)Other patients determined to be inappropriate by physician

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Sasaki

Organization

Jikei University School of Medicine Kashiwa Hospital

Division name

Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine

Zip code


Address

136-1 Kashiwasita, Kashiwa city, Chiba 277-8567 Japan

TEL

04-7164-1111

Email

tsasaki-endo@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Sasaki

Organization

Jikei University School of Medicine Kashiwa Hospital

Division name

Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine

Zip code


Address

136-1 Kashiwasita, Kashiwa city, Chiba 277-8567 Japan

TEL

04-7164-1111

Homepage URL


Email

tsasaki-endo@umin.ac.jp


Sponsor or person

Institute

Jikei University School of Medicine Kashiwa Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

東京慈恵会医科大学附属柏病院(千葉県) Jikei University School of Medicine Kashiwa Hospital(Chiba)


Other administrative information

Date of disclosure of the study information

2011 Year 12 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

2011 Year 10 Month 04 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 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

2011 Year 10 Month 04 Day

Last modified on

2014 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007677


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name