UMIN-CTR Clinical Trial

Public title

A clinical study of a combination drug for type2 diabetes
-Using self-monitoring of blood glucose and meal tolerance test-

Acronym

A clinical study of a combination drug for type2 diabetes
-Using self-monitoring of blood glucose and meal tolerance test-

Scientific Title

A clinical study of a combination drug for type2 diabetes
-Using self-monitoring of blood glucose and meal tolerance test-

Scientific Title:Acronym

A clinical study of a combination drug for type2 diabetes
-Using self-monitoring of blood glucose and meal tolerance test-

Region

Japan

Condition

type2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Study the efficacy of Glubes combination tablets in hyperglycemia and hyperlipidemia after a meal, using self-monitoring of blood glucose and meal tolerance tests after repetitive administrations of Glubes combination tablets and 10mg of Glufast in patients with type2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Efficacy endpoints:Blood glucose levels by SMBG. Amounts and changing value of blood glucose, insulin, proinsulin, C-peptide, glucagon, GLP-1, LDL-C, HDL-C, triglyceride, RLP-C, and free fatty acid after meal tolerance test, for each measurement point will be evaluated with descriptive statistics
Amounts and changing value of HbA1c, blood glucose, glycosylated albumin and 1.5-AG for each measurement point will be evaluated with descriptive statistics
Safety endpoints:The incident rate and the situation of side effects and adverse events during observation and treating periods.
Laboratory evidence is the use of descriptive statistics.

Key secondary outcomes

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

Check the blood glucose levels by self-monitoring nine times totally; three times in a day for observation period and administration period of Glufast or Glubes combination tablets.Take blood and urine sample and do a meal tolerance test at the clinic for each three period.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients only treated by diet and exercise therapy, or patients treated by oral hypoglycemic agents except SU or insulin who can have washout periods with those agents for more than four weeks
2) Possible to take the test meal (a set of Chicken in white sauce, crackers, soft pudding)
3) Over 20 years old
4) Voluntarily signed to the consent form after taking enough explanation of the significance and the objectives of this study

Key exclusion criteria

1) Patients who are applicable to the [taboo issue] in a package insert of Glubes combination tablets.
Patients who have severe ketosis, precoma or diabetic coma or type 1 diabetes.
Patients with severe infection or severe injury.
Patients accepting surgery.
Patients with a history of hypersensitivity to any component of this drug.
Pregnant women and women suspected to be pregnant.
2) Patients whom the principal investigator and investigators decided not to be appropriate for taking Glubes combination tablets, on the point of [Special caution needed] and [side effects] in the package insert.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Yuri Ono

Organization

Yuri Ono Clinic Diabetes,Internal medicine

Division name

M.D

Zip code

Address

Sapporo Fukoku-Seimei-Ekimaedori Building 3F 1-17,Kita-2,Nishi-3,Chuo-Ku,sapporo,060-0002,Japan

TEL

011-223-5152

Email

erika-yamagishi@npo-acro.jp

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

Institute

Advanced Clinical Research Organization

Institute

Department

Personal name

Organization

Advanced Clinical Research Organization

Organization

Division

Category of Funding Organization

Other

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

Date of disclosure of the study information

2012

Year

02

Month

03

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2011

Year

12

Month

08

Day

Date of IRB

Anticipated trial start date

2012

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

02

Month

02

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=R000008374