UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048203 |
|---|---|
| Receipt number | R000054936 |
| Scientific Title | Long-term efficacy of anagliptin in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2023/01/05 11:22:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Long-term efficacy of anagliptin in patients with type 2 diabetes mellitus
Acronym
Long-term efficacy of anagliptin in patients with type 2 diabetes mellitus
Scientific Title
Long-term efficacy of anagliptin in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Long-term efficacy of anagliptin 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 aim of this study was to compare the effects of anagliptin on metabolic parameters, as well as markers of hepatic, renal, and arterial stiffness, before and after administration of anagliptin in patients with type 2 diabetes and to retrospectively investigate its long-term efficacy as well as organ protective effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HbA1c level 5 years after administration of anagliptin in patients with type 2 diabetes.
Key secondary outcomes
Changes in the following parameters and markers after administration of anagliptin
1. Metabolic parameters; HbA1c, GA, weight, BMI
2. Liver enzyme markers; AST, ALT, gamma GTP
3. Liver fibrosis markers; Fib-4 index
4. Renal function markers; eGFR, eGFR slope, urinary albumin-creatinine ratio (UACR)
5. Arterial stiffness markers; IMT (mean, maximum), baPWV, API
6. Hemodynamic markers; systolic and diastolic blood pressure, heart rate
7. Lipid markers; total cholesterol, LDL-C, HDL-C, TG
8. Hypoglycaemic markers; subjective hypoglycemia, unawareness hypoglycemia (SMBG)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Outpatients with type 2 diabetes
2.Patients aged 20 years or older on the date of anagliptin administration start
3.Patients who received anagliptin
Key exclusion criteria
1.Type 1 diabetes
2.Patients in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Osonoi |
Organization
Naka Kinen Clinic
Division name
department of internal medicine
Zip code
311-0113
Address
745-5 Nakadai, Naka-shi, Ibaraki
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Ofuchi |
Organization
Naka Kinen Clinic
Division name
Department of clinical research laboratory
Zip code
311-0113
Address
745-5 Nakadai, Naka-shi, Ibaraki
TEL
029-353-2800
Homepage URL
t-osonoi@kensei-kai.com
Sponsor or person
Institute
Naka Kinen Clinic
Institute
Department
Personal name
Funding Source
Organization
Sanwa Kagaku Kenkyusho Co., Ltd.
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
the ethics review committee of the Naka Kinen Clinic
Address
745-5 Nakadai, Naka-shi, Ibaraki
Tel
029-353-2800
t-osonoi@kensei-kai.com
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
| 2022 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.shinryo-to-shinyaku.com/index.html
Number of participants that the trial has enrolled
299
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
| 2022 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Anagliptin in the treatment of type 2 diabetes: safety, efficacy, and patient acceptability
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054936
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
