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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010061
Receipt No. 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

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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
Email 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
Email t-osonoi@kensei-kai.com

Sponsor
Institute SANWA KAGAKU KENKYUSHO CO.,LTD
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011742

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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