UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	Clinical study on combination therapy with a DPP-4 inhibitor and the combination in T2DM patients
Region	Japan

Condition
Condition	T2DM
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
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

Research contact person
Name of lead principal investigator	Yuri Ono
Organization	Yuri Ono Clinic, Diabetes, Internal Medicine
Division name	Director
Address	3-27, Nishi 3, Kita 1, Chuo-Ku, Sapporo
TEL	011-223-5152
Email	info@inc-re.com

Public contact
Name of contact person	Yuri Ono
Organization	Yuri Ono Clinic, Diabetes, Internal Medicine
Division name	Director
Address	3-27, Nishi 3, Kita 1, Chuo-Ku, Sapporo
TEL	011-223-5152
Homepage URL
Email	info@npo-acro.jp

Sponsor
Institute	Yuri Ono Clinic, Diabetes, Internal Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	2013 Year 11 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 14 Day
Last modified on	2016 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014377