UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012294 |
|---|---|
| Receipt number | 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 17:26:15 |
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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
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
info@npo-acro.jp
Sponsor or person
Institute
Yuri Ono Clinic, Diabetes, Internal Medicine
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014377
