UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010061 |
|---|---|
| Receipt number | R000011742 |
| Scientific Title | Clinical Implications of Triple Combination Therapies(Metformin+Alpha-glucosidase Inhibitor+DPP-4 Inhibitor) in Type 2 Diabetes |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2014/06/18 11:16:32 |
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Basic information
Public title
Clinical Implications of Triple Combination Therapies(Metformin+Alpha-glucosidase Inhibitor+DPP-4 Inhibitor) in Type 2 Diabetes
Acronym
Clinical Implications of Triple Combination Therapies(Metformin+Alpha-glucosidase Inhibitor+DPP-4 Inhibitor) in Type 2 Diabetes
Scientific Title
Clinical Implications of Triple Combination Therapies(Metformin+Alpha-glucosidase Inhibitor+DPP-4 Inhibitor) in Type 2 Diabetes
Scientific Title:Acronym
Clinical Implications of Triple Combination Therapies(Metformin+Alpha-glucosidase Inhibitor+DPP-4 Inhibitor) in Type 2 Diabetes
Region
| Japan |
Condition
Condition
Type 2 Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinical study determines the safety and efficacy of anagliptin orally administered during 52-week treatment period in patients with type 2 diabetes mellitus who have inadequate glycemic control by metformin,miglitol,or metformin+miglitol treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy:HbA1c,Glyco-albumin,Fasting blood glucose,Serum lipid(TG,TC,LDL-C,HDL-C),Meal load test(Post prandial glucose,active-GLP-1,active-GIP,Ghrelin,PYY,Leptin),Body weight,Body fat percentage,amount of fat
Safety:AE,clinical laboratory test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Metformin+Anagliptin
Interventions/Control_2
Miglitol+Anagliptin
Interventions/Control_3
Metformin+Miglitol+Anagliptin
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 with type 2 diabetes receiving either metformin and/or miglitol for at least two months before the start of the run-in period without any changes in the type or dosage of the drug
2.HbA1c(NGSP) is less than 8.0% more than 6.5% measured during the run-in period
Key exclusion criteria
1.Patients require insulin or oral antidiabetic drug therapy other than metformin and/or miglitol
2.Female patients who were pregnant,suspected of being pregnant,planning a pregnancy,or lactating
3.Patients with,or a history of,serious renal disease(Serum Creatinine of >=2mg/dL
4.Any patients deemed by the investigator to be ineligible for participation in this study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Nakakinen Clinic
Division name
Director
Zip code
Address
745-5,Nakadai,Naka-city,Ibaraki-ken,311-0113,Japan
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Nakakinen Clinic
Division name
Director
Zip code
Address
745-5,Nakadai,Naka-city,Ibaraki-ken,311-0113,Japan
TEL
029-353-2800
Homepage URL
t-osonoi@kensei-kai.com
Sponsor or person
Institute
SANWA KAGAKU KENKYUSHO CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Life and Environmental Sciences,University of Yamanashi
Name of secondary funder(s)
None
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
那珂記念クリニック（茨城県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 01 | 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
| 2012 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 18 | Day |
Last modified on
| 2014 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011742
