UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004674
Receipt number R000005463
Scientific Title Examine the comparative availability of DPP-4 Inhibitor versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who was treated with Sulfonylurea
Date of disclosure of the study information 2010/12/07
Last modified on 2013/06/29 22:58:49

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Basic information

Public title

Examine the comparative availability of DPP-4 Inhibitor versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who was treated with Sulfonylurea

Acronym

Study for an ultimate combination therapy to control diabetes with Sitagliptin-2

Scientific Title

Examine the comparative availability of DPP-4 Inhibitor versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who was treated with Sulfonylurea

Scientific Title:Acronym

Study for an ultimate combination therapy to control diabetes with Sitagliptin-2

Region

Japan


Condition

Condition

Type 2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine the comparative availability of DPP-4 Inhibitor, Sitagliptin versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who responded suboptimal glycemic control with Sulfonylurea alone.

Basic objectives2

Others

Basic objectives -Others

Examine the clinical availability on Sitagliptin by comparing the lipid metabolism, oxidative-stress marker and tolerability.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Change of HbA1c from the baseline to 12 weeks later

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sulfonylurea (glimepiride) + Stagliptin

Interventions/Control_2

Sulfonylurea (glimepiride) + Alpha-Glycosidase inhibitor

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Patients with type 2 diabetes
2)Patients with suboptimal glycemic control by glimepiride 2mg/day for more than 2 months treatments.
3)Age >=20 years, <80 years (Male and Female)
4)A consent form for participating in this study is submitted

Key exclusion criteria

1)Patients with type 1 diabetes
2)History of severe ketosis, diabetic coma or precoma within 6 months
3)Patients with severe infections, before or after operation, or with serious trauma
4)Patients with exceeding the moderate renal impairment
5)Patients with history of stroke, MI or other sever vascular complication which required a hospitalization within six months.
6)Patients receiving DPP-4 Inhibitor except Sitagliptin
7)Patients receiving Alfa-glycosidase inhibitor, Sulfonylurea or Glinide during obtaining the informed consent or received Insulin treatment in the past 2 months.
Patients receiving alfa-glucosidase inhibitor or suruhoniyl urea or glinide at getting the informed consent or recieving Insulin within 2 months
8)Patients receiving glimepiride more than 2mg/day at getting the informed concent
9)Patients who are pregnant, breastfeeding or intention to becoming pregnant
10)Having allergy to DPP-4 Inhibitor or alfa-glucosidase inhibitor
11)Other patients determined to be inappropriate by physician

Target sample size

114


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kotaro Yokote

Organization

Graduate School of Medicine, Chiba University

Division name

Clinical Cell Biology and Medicine

Zip code


Address

1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Graduate School of Medicine, Chiba University

Division name

Clinical Cell Biology and Medicine

Zip code


Address

1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city

TEL


Homepage URL


Email



Sponsor or person

Institute

Graduate School of Medicine, Chiba University

Institute

Department

Personal name



Funding Source

Organization

Waksman Financial Group

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

2010 Year 12 Month 07 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

Completed

Date of protocol fixation

2010 Year 11 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2012 Year 08 Month 10 Day

Date of closure to data entry


Date trial data considered complete

2012 Year 10 Month 14 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 12 Month 07 Day

Last modified on

2013 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005463


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name