UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000010409
Receipt number	R000012013
Scientific Title	Clinical study on glycemic excursion improvements with a fixed mitiglinide / voglibose combination in patients with type 2 diabetic mellitus(T2DM) - research into glycemic excursion-improving mechanisms -
Date of disclosure of the study information	2013/04/03
Last modified on	2013/09/27 09:28:51

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Basic information

Public title

Clinical study on glycemic excursion improvements with a fixed mitiglinide / voglibose combination in patients with type 2 diabetic mellitus(T2DM)
- research into glycemic excursion-improving mechanisms -

Acronym

Clinical study on glycemic excursion-improving mechanisms in the T2DM patients

Scientific Title

Scientific Title:Acronym

Clinical study on glycemic excursion-improving mechanisms in the T2DM patients

Region

Japan

Condition

T2DM

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

A mitiglinide / voglibose combination will be administered for 4 weeks in the T2DM patients, with meal load tests using unified meals in the mornings, afternoons and evenings, before and after 4-weeks, treatment, and with metabolic parameters being evaluated before and after each meal, to elucidate improvement mechanisms in glycemic excursion after meals with the combination.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Efficacy endpoints are various metabolic parameter measures as well as changes from baseline and their AUC before and after 4-weeks treatment with the combination, and over 120 minutes after meals in the morning, afternoon and evening meals

Key secondary outcomes

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

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

After an observation period, the combination will be administered for 4 weeks, and meal load tests will be done using unified meals at the clinic before and after 4-weeks treatment.

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)T2DM patients treated with a diabetic diet and exercise regimens for their diabetes, or, patients for whom a washout period or 4 weeks or more can be established for any hypoglycemic agent they have been treated with, other than an SU or insulin
2)Patients able to take the test meals
3)Patients age 20 years or older
4)Patients to whom the significance, objectives and methods of this study have been explained, and from whom consent can be willingly obtained

Key exclusion criteria

1)Patients to whom [Contraindications] in labeling for the combination apply
2)Any others who the principal investigator deems unsuitable as subjects, in consideration of any [Special caution needed] in labeling for the combination

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yuri Ono

Organization

Yuri Ono Clinic, Diabetes, Internal Medicine

Division name

Director

Zip code

Address

1-7, Nishi 3, Kita 2, Chuo-Ku, Sapporo

TEL

011-223-5152

Email

erika-yamagishi@npo-acro.jp

Public contact

Name of contact person

1st name

Middle name

Last name Erika Yamagishi

Organization

Yuri Ono Clinic, Diabetes, Internal Medicine

Division name

Yuri Ono Clinic, Diabetes, Internal Medicine

Zip code

Address

1-7, Nishi 3, Kita 2, Chuo-Ku, Sapporo

TEL

011-223-5152

Homepage URL

Email

erika-yamagishi@npo-acro.jp

Sponsor or person

Institute

Yuri Ono Clinic, Diabetes, Internal Medicine

Institute

Department

Personal name

Funding Source

Organization

Advanced Clinical Research Organization

Organization

Division

Category of Funding Organization

Other

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 03 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

2013 Year 02 Month 27 Day

Date of IRB

Anticipated trial start date

2013 Year 03 Month 18 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 04 Month 03 Day

Last modified on

2013 Year 09 Month 27 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012013

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name