UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018311 |
|---|---|
| Receipt number | R000021183 |
| Scientific Title | The effect of trelagliptin on vascular endothelial functions in patients with type II diabetes mellitus. |
| Date of disclosure of the study information | 2015/07/15 |
| Last modified on | 2016/11/15 20:47:02 |
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Basic information
Public title
The effect of trelagliptin on vascular endothelial functions in patients with type II diabetes mellitus.
Acronym
The effect of trelagliptin on vascular endothelial functions in patients with type II diabetes mellitus.
Scientific Title
The effect of trelagliptin on vascular endothelial functions in patients with type II diabetes mellitus.
Scientific Title:Acronym
The effect of trelagliptin on vascular endothelial functions in patients with type II diabetes mellitus.
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of trelagliptin on vascular endothelial functions in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow mediated dilation (FMD)
Key secondary outcomes
Hemoglobin A1C levels, pre/postprandial blood glucose/lipids levels, BMI, adiponectin, ADMA, mean IMT, mean ba-PWV
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
Oral trelagliptin administration (100 mg) once a week after breakfast
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Outpatients
2) Inadequate glucose control even after dietary and exercise therapies for more than 8 weeks
3) No previous administration of pioglitazone as an oral hypoglycemic drug
4) 6.5% more than fasting HbA1c under 10%
5) fasting blood glucose levels greater than 110mg/dl and under 250mg/dl
6) Patients who themselves can voluntarily provide consent to participate in this study, and can also follow the study protocol
Key exclusion criteria
1) type 1 diabetes
2) secondary diabetes
3) Patients receiving insulin or GLP-1 analogue therapy
4) Poor-controlled diabetes (HbA1c>10.0 % or fasting blood glucose levels greater than 250mg/dl)
5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
6) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits
7) renal insufficiency: serum creatinine>1.5
8) Malignancies or other diseases with poor prognosis
9) Pregnant
10) Subjects whose doctor in charge do not agree to join the trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ida |
Organization
Ise Red Cross Hospital
Division name
Department of Metabolic Diseases
Zip code
Address
1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL
0596-28-2171
bboy98762006@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ida |
Organization
Ise Red Cross Hospital
Division name
Department of Metabolic Diseases
Zip code
Address
1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL
0596-28-2171
Homepage URL
bboy98762006@yahoo.co.jp
Sponsor or person
Institute
Ise Red Cross Hospital
Department of Metabolic Diseases
Institute
Department
Personal name
Funding Source
Organization
Ise Red Cross Hospital
Department of Metabolic Diseases
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 17 | 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
| 2015 | Year | 07 | Month | 14 | Day |
Last modified on
| 2016 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021183
