UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014298 |
|---|---|
| Receipt number | R000013942 |
| Scientific Title | Efficacy and safety of teneligliptin in patients with type 2 diabetes who responded insufficiently to dipeptidyl peptidase-4 (DPP-4) inhibitors |
| Date of disclosure of the study information | 2014/06/18 |
| Last modified on | 2015/02/06 12:20:21 |
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Basic information
Public title
Efficacy and safety of teneligliptin in patients with type 2 diabetes who responded insufficiently to dipeptidyl peptidase-4 (DPP-4) inhibitors
Acronym
Efficacy and safety of teneligliptin in patients with type 2 diabetes who responded insufficiently to dipeptidyl peptidase-4 (DPP-4) inhibitors
Scientific Title
Efficacy and safety of teneligliptin in patients with type 2 diabetes who responded insufficiently to dipeptidyl peptidase-4 (DPP-4) inhibitors
Scientific Title:Acronym
Efficacy and safety of teneligliptin in patients with type 2 diabetes who responded insufficiently to dipeptidyl peptidase-4 (DPP-4) inhibitors
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The porpose of the study is to determine the efficacy and safety of teneligliptin treatment once daily for 12 weeks in patients with type 2 diabetes in whom treatment with a dipeptidyl peptidase-4 (DPP-4) inhibitor, other than teneligliptin, was effective, but the treatment efficacy seemed to decrease thereafter
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Glycosylated hemoglobin(HbA1c) levels over 12 weeks,Change in DPP-4 activity
Key secondary outcomes
Active Glucagon-like peptide-1 (GLP-1) concentration,Active Gastric inhibitory Polypeptide (GIP) concentration,Glucagon levels,Postprandial (1 and 2 hour) glucose levels,Fasting blood glucose levels,Insulin levels
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
teneligliptin
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) Submission of written informed consent for participation in this study
(2) Either gender
(3) Age >=20 years on the date of submission of informed consent
(4) Clinic visit
(5) Previous treatment with any oral antidiabetic agent, other than a DPP-4 inhibitor, with a fixed dose and regimen of >=12 weeks and HbA1c levels (National Glycohemoglobin Standardization Program) in a rebound state of >=0.3% at week 0 despite an initial reduction in HbA1c levels >=0.5% by previous treatment with a DPP-4 inhibitor, other than teneligliptin
(6) HbA1c levels of >=6.9% to <10.4%, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases
(7) Difference in HbA1c levels <0.5% at the start date and 4 weeks before the start of administration
Key exclusion criteria
(1) Type-1 diabetes, diabetes due to a pancreatic disorder, or secondary diabetes due to conditions such as Cushing's syndrome and acromegaly
(2) Application of contraindications contained in the package insert
(3) Excessive alcohol consumption : mean daily intake of pure alcohol >=60g
(4) Pregnant women, women suspected of being pregnant, or lactating women
(5) Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Naka Kinen Clinic
Division name
Director
Zip code
Address
745-5,Nakadai,Naka-city,Ibaraki,311-0113,Japan
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Ofuchi |
Organization
Naka Kinen Clinic
Division name
Clinical Laboratory
Zip code
Address
745-5,Nakadai,Naka-city,Ibaraki,311-0113,Japan
TEL
029-353-2800
Homepage URL
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Naka Kinen Clinic
Institute
Department
Personal name
Funding Source
Organization
Japan Vascular Disease Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
那珂記念クリニック(茨城県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 18 | 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 | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 18 | Day |
Last modified on
| 2015 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013942
