UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006199
Receipt number R000007330
Scientific Title A Clinical trial of compound drugs for patients with type2 diabetes - Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. -
Date of disclosure of the study information 2011/09/01
Last modified on 2013/09/27 09:29:20

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Basic information

Public title

A Clinical trial of compound drugs for patients with type2 diabetes
- Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. -

Acronym

A Clinical trial of compound drugs for patients with type2 diabetes
- Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. -

Scientific Title

A Clinical trial of compound drugs for patients with type2 diabetes
- Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. -

Scientific Title:Acronym

A Clinical trial of compound drugs for patients with type2 diabetes
- Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. -

Region

Japan


Condition

Condition

type2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Conduct a meal tolerance test by the test meal after single dose administration of voglibose 0.2mg, mitiglinide calcium hydrate 10mg, and glubes combination tablets for patients with type2 diabetes
Compare the change in blood glucose and lipid metabolic parameter, and the statistics of each group for studying improvement of postprandial metabolic disorder.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy endpoints: Measure the summary statistics of the measurement value and the changing value of the parameter (glucose, insulin, triglycerides, RLP-C, free fatty acids) after a meal tolerance test.
Measure the summary statistics of Emax, tmax and AUEC0-180.

Safety endpoints: The incidence of adverse events and side effect. For laboratory evidence, summary statistics are calculated.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A: control observation period (water,meal tolerance test)--washout--in stage 1 (BASEN,meal tolerance test)--washout--in stage 2(GLUBES,meal tolerance test)--washout--in stage 3 (GLUFAST,meal Tolerance Test)

Interventions/Control_2

Group B: control observation period (water,meal tolerance test)--washout--in stage 1(GLUFAST,meal tolerance test)--washout--in stage 2(BASEN,meal tolerance test)--washout--in stage 3(GLUBES,meal Tolerance Test)

Interventions/Control_3

Group C: control observation period (water,meal tolerance test)--washout--in stage 1(GLUBES,meal tolerance test)--washout--in stage 2(GLUFAST,meal tolerance test)--washout--in stage 3(BASEN,meal Tolerance Test)

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 treated only by a diabetes diets and exercise regimen or Patients who can have a washout period of glucositase inhibitor or glinide for more than 4weeks.
2) Patients who have been type2 diabetes blow 10 years.
3) Patients who is possible to ingest the test meal (a set of chicken cream, crackers and soft pudding).
4) Adult patients (>=20years) (at the time taking an agreement)
5) Outpatients
6) Patients who can voluntary agree to this study after being taken an explanation for significance and objectives of this study.

Key exclusion criteria

1) Patients having been treated by sulfonylureas within 3 months.
2) Patients treated by hyperlipidemia of fibrates.
3) Patients with a BMI of 40 or more.
4) Patients falling under the [contraindication] in attached files of the experimental drugs.
5) Patients falling under the [Special caution needed] in attached files of the experimental drugs and whom have high disability, and whom principal investigator concludes to be unsuitable for the test.
6) Patients whom principal investigator concludes to be unsuitable for the test, in other reasons.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Inoue

Organization

Sasazuka inoue clinic

Division name

M.D

Zip code


Address

Sasazuka1-15-4,Shibuya-ku,Tokyo AKI Bildg.

TEL

03-3466-3348

Email

erika-yamagishi@npo-acro.jp


Public contact

Name of contact person

1st name
Middle name
Last name Erika Yamagishi

Organization

NPO Advanced Clinical Research Organization

Division name

NPO Advanced Clinical Research Organization

Zip code


Address

4F Hoei Fuchu Bulding,2-10-3 Kotobukicho,Fuchu-shi,Tokyo

TEL

042-352-7676

Homepage URL


Email

erika-yamagishi@npo-acro.jp


Sponsor or person

Institute

Advanced Clinical Research Organization

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

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

2011 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

2011 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 09 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 08 Month 19 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=R000007330


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name