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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012294
Receipt No. R000014377
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)
Date of disclosure of the study information 2013/11/14
Last modified on 2016/05/30

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Basic information
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
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

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

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
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

Public contact
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

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

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
2013 Year 11 Month 14 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 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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