UMIN-CTR Clinical Trial

Public title

Clinical study on of combination therapy with a DPP-4 inhibitor and a mitiglinide/voglibose fixed-dose combination (the combination) on glycemic/metabolic responses after meals in patients with type 2 diabetic mellitus (T2DM)

Acronym

Clinical study on combination therapy with a DPP-4 inhibitor and the combination in T2DM patients

Scientific Title

Clinical study on of combination therapy with a DPP-4 inhibitor and a mitiglinide/voglibose fixed-dose combination (the combination) on glycemic/metabolic responses after meals in patients with type 2 diabetic mellitus (T2DM)

Scientific Title:Acronym

Clinical study on combination therapy with a DPP-4 inhibitor and the combination in T2DM patients

Region

Japan

Condition

T2DM

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the improvements of glycemic/metabolic responses in T2DM patients who are on DPP-4 inhibitor medication in a open label cross-over study. Patients are randomly assigned to two groups, co-administration with the combination for 2 times per day or 3 times per day for 2 weeks treatment period. The meal tolerance test is conducted before and at the end of treatment period for 3 times per day, breakfast, lunch and dinner using the same meals.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Efficacy endpoints are the actual measured value of glycemic/metabolic parameters over 120 minutes after each meal, the changes from baseline and the AUC over 120 minutes after each meal of breakfast, lunch and dinner in each treatment period.

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

After an observation period of DPP-4 inhibitor treatment, patients are randomly assigned to two groups, co-administration with the combination for 2 times per day or 3 times per day for 2 2-weeks treatment period. The meal tolerance test is conducted before and at the end of the treatment periods for 3 times per day.

Interventions/Control_2

After an observation period of DPP-4 inhibitor treatment, patients are randomly assigned to two groups, co-administration with the combination for 2 times per day or 3 times per day for 2 2-weeks treatment period. The meal tolerance test is conducted before and at the end of the treatment periods for 3 times per day.

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) T2DM patients who are insufficient glycaemic control, during treatment of a DPP-4 inhibitor for 8 weeks or more under a diet and exercise therapy
2) Patients who are able to take the test meals
3) Patients whose age are 20 years or older
4) Patients who have been explained the purpose, objectives and methods of this study, and submitted the written informed consent to participate the study.

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

12

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

3-27, Nishi 3, Kita 1, Chuo-Ku, Sapporo

TEL

011-223-5152

Email

info@inc-re.com

Name of contact person

1st name
Middle name
Last name	Yuri Ono

Organization

Yuri Ono Clinic, Diabetes, Internal Medicine

Division name

Director

Zip code

Address

3-27, Nishi 3, Kita 1, Chuo-Ku, Sapporo

TEL

011-223-5152

Homepage URL

Email

info@npo-acro.jp

Institute

Yuri Ono Clinic, Diabetes, Internal Medicine

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

2013

Year

11

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

2013

Year

10

Month

29

Day

Date of IRB

Anticipated trial start date

2013

Year

11

Month

18

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

11

Month

14

Day

Last modified on

2016

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014377