UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026185 |
|---|---|
| Receipt number | R000021729 |
| Scientific Title | Effect of oral hypoglycemic agent for postprandial hyperglycemia administered two times daily on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets |
| Date of disclosure of the study information | 2017/02/17 |
| Last modified on | 2018/08/20 14:34:47 |
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Basic information
Public title
Effect of oral hypoglycemic agent for postprandial hyperglycemia administered two times daily on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets
Acronym
Effect of twice daily administration on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets.
Scientific Title
Effect of oral hypoglycemic agent for postprandial hyperglycemia administered two times daily on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets
Scientific Title:Acronym
Effect of twice daily administration on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of oral hypoglycemic agent for postprandial hyperglycemia administered two times daily on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c
Comparison at16weeks,24 weeks from the start of administration
Key secondary outcomes
GA
1.5AG
Fasting blood glucose
Fasting insulin
HOMA-R
Serum CPR
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Mitiglinide calcium hydrate administration group
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
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients are being treated with diet therapy and DPP-4 inhibitor, metformin for more than 8 weeks (56 days) prior to the start of the study.
2)HbA1c (NGSP) before clinical trial start is 7.0% or more and 9.0% or less.
3)Patients are not clinically problematic anemia.
4)over 20 years age
5)Out patient
6)Patients who provided written consent
Key exclusion criteria
1) Patients with contraindications against the use of mitiglinide calcium hydrate tablets and mitiglinide calcium hydrate/voglibose combimation tablets based on their package inserts.
2) Patients who had taken sulfonylureas, GLP-1 receptor agonists,glinide,a-GI, SGLT-2 inhibitors, insulin within 8 weeks (56 days) before the start of the study
3) Excessive drinkers
4) Patients with severe diabetic microangiopathy
5) Patients with severe liver / kidney function decline
6) Patients with severe heart disease
7) Patients with severe hypertension combined
8) Patients with open surgery or previous bowel obstruction
9)Patients who were judged to be ineligible to be ineligible by the investigator or sub-investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Tanaka |
Organization
St.Marianna University School of Medicine
Division name
Division of Endocrinology and Metabolism
Zip code
Address
2-16-1
TEL
044-977-8111
y2tanaka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kato |
Organization
St.Marianna University School of Medicine Hospital
Division name
Division of Endocrinology and Metabolism
Zip code
Address
2-16-1 Sugou, Miyamae-ku Kawasaki-city Kanagawa-ken
TEL
044-977-8111
Homepage URL
h.k.kato@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2017 | Year | 02 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 31 | 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
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2018 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021729
