UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030532 |
|---|---|
| Receipt number | R000034850 |
| Scientific Title | The effect of anagliptin on blood glucose and serum lipids in Patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2022/06/26 14:04:53 |
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Basic information
Public title
The effect of anagliptin on blood glucose and serum lipids in Patients with type 2 diabetes mellitus
Acronym
The effect of anagliptin on blood glucose and serum lipids in patients with type 2 diabetes mellitus
Scientific Title
The effect of anagliptin on blood glucose and serum lipids in Patients with type 2 diabetes mellitus
Scientific Title:Acronym
The effect of anagliptin on blood glucose and serum lipids in patients with type 2 diabetes mellitus
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 purpose of this study is to investigate the effect of anagliptin from another DPP-4 inhibitor on blood glucose and lipid levels and in patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of HbA1c and lipid levels(LDL-C,MDA-LDL,RLP-C)
Key secondary outcomes
1. Change of HbA1c and lipid levels
2. The change of glycemic and lipid parameters
3. The analysis of baseline characteristics
4. The analysis of backgorund factors which affect glycemic and lipid control
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Before test registration -anagliptin within 2 weeks outpatient
2. Type 2 diabetes
3. LDL-C more than 120 mg/dL
4. No plan to add other OHA
5. Age more than 20, less than 85
6. Patients with written IC
Key exclusion criteria
1. Allergy for anagliptin.
2. Severe ketosis, diabetic coma severe infection, before operation, severe trauma
3. Severe renal dysfunction including hemodialysis or peritoneal dialysis (SCr:more than 1.5mg/dl )
4. Pregnancy
5. Patients judged by the investigator to be ineligible for some other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Okamoto |
Organization
Japan Community Health care Organization, Yokohama Hodogaya Central Hospital
Division name
Department of Medicine(Endocrinology, Diabetes and Metabolism)
Zip code
240-8585
Address
43-1 Kamadai-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8585, Japan
TEL
045-331-1251
okamoto-ykh@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Okamoto |
Organization
Japan Community Health care Organization, Yokohama Hodogaya Central Hospital
Division name
Department of Medicine(Endocrinology, Diabetes and Metabolism)
Zip code
240-8585
Address
43-1 Kamadai-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8585, Japan
TEL
045-331-1251
Homepage URL
okamoto-ykh@umin.ac.jp
Sponsor or person
Institute
Japan Community Health care Organization, Yokohama Hodogaya Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Japan Community Health care Organization, Yokohama Hodogaya Central Hospital
Address
43-1 Kamadai-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8585, Japan
Tel
045-331-1251
shiratori-yutaka@hodogaya.jcho.go.jp
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
| 2017 | Year | 12 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034850
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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