UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017064 |
|---|---|
| Receipt number | R000019790 |
| Scientific Title | Effect of Anagliptin and Sitagliptin on low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors: Randomized controlled trial |
| Date of disclosure of the study information | 2015/04/08 |
| Last modified on | 2019/02/03 12:03:13 |
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Basic information
Public title
Effect of Anagliptin and Sitagliptin on low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors: Randomized controlled trial
Acronym
Randomized Evaluation of Anagliptin versus Sitagliptin On low-density lipoproteiN cholesterol in diabetes Trial
Scientific Title
Effect of Anagliptin and Sitagliptin on low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors: Randomized controlled trial
Scientific Title:Acronym
Randomized Evaluation of Anagliptin versus Sitagliptin On low-density lipoproteiN cholesterol in diabetes Trial
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes with cardiovascular risk factors who treated with diet, exercise or antidiabetic medications
Patients who were treated with statins for 8 weeks or longer
Patients with low-density lipoprotein cholesterol equal to or greater than 100 mg/dL in the at least one of three measurements after the administration of statins
Patients with glycerated hemoglobin (HbA1c, NGSP) equal to or greater than 6.0 % (7.0 % if patients were not treated with dipeptidyl-peptidase 4 inhibitors) and lesser than 10.5 %
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors on statin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in low-density lipoprotein cholesterol
Change in glycated hemoglobin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Anagliptin
Interventions/Control_2
Sitagliptin
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
Patients with type 2 diabetes with cardiovascular risk factors who treated with diet, exercise or antidiabetic medications
Patients who were treated with statins for 8 weeks or longer
Patients with low-density lipoprotein cholesterol equal to or greater than 100 mg/dL in the at least one of three measurements after the administration of statins
Patients with glycerated hemoglobin (HbA1c, NGSP) equal to or greater than 6.0 % (7.0 % if patients were not treated with dipeptidyl-peptidase 4 inhibitors) and lesser than 10.5 %
Key exclusion criteria
1) Patients with type 1 diabetes
2) Patients with triglyceride equal to or greater than 400 mg/dL in the previous fasting measuments
3) Patients with pregnancy, possible pregnancy, or on breast-feeding
4) Patients with severe infections, perioperative status, or severe trauma
5) Patients with elevated creatinine (>=2.4 mg/dl for men; >=2.0 mg/dl for women)
6) Patients who were received glucagon-like peptide-1receptor agonists
7) Patients whom physician in charge considered inappropriate for the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Ueda |
Organization
University of the Ryukyus
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
Nishihara, Okinawa
TEL
098-895-1195
suedano9@dream.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Morimoto |
Organization
Hyogo College of Medicine
Division name
Department of Clinical Epidemiology
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6879
Homepage URL
tm@hyo-med.ac.jp
Sponsor or person
Institute
Institute for Clinical Effectiveness
Institute
Department
Personal name
Funding Source
Organization
Kowa
Organization
Division
Category of Funding Organization
Profit organization
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
YES
Study ID_1
NCT02330406
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 08 | 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
| 2014 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 08 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 07 | Day |
Last modified on
| 2019 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019790
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