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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000041979 |
Receipt No. | R000047914 |
Scientific Title | Effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes: a retrospective observational study |
Date of disclosure of the study information | 2020/10/02 |
Last modified on | 2020/10/02 |
Basic information | ||
Public title | Effects of anagliptin/metformin combination tablets: a retrospective observational study | |
Acronym | Effects of anagliptin/metformin combination tablets: a retrospective observational study | |
Scientific Title | Effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes: a retrospective observational study | |
Scientific Title:Acronym | Effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes: a retrospective observational study | |
Region |
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Condition | ||
Condition | Type 2 diabetes mellitus | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study aims to evaluate the effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Change in HbA1c |
Key secondary outcomes | 1.Change in LDL-C
2.Change in HDL-C 3.Change in eGFR 4.Change in body weight, BMI and body composition 5.Incidence of adverse events |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Patients with type 2 diabetes
2. Patients who started receiving of anagliptin / metformin hydrochloride combination tablets from November 21st, 2018 to May 31st, 2020 (data collection period) and continued for more than 12 weeks |
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Key exclusion criteria | 1. Patients who received antidiabetic drugs for less than 8 weeks before switch to anagliptin / metformin hydrochloride combination tablets
2. Patients who denied the use of clinical medical records to the study |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Fukuda Clinic | ||||||
Division name | Internal Medicine | ||||||
Zip code | 532-0003 | ||||||
Address | 2F Shin-Osaka Brick Building, 1-6-1, Miyahara, Yodogawa-ku, Osaka-shi, Osaka Japan | ||||||
TEL | 06-6398-0203 | ||||||
fukuda@drmog.jp |
Public contact | |||||||
Name of contact person |
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Organization | Fukuda Clinic | ||||||
Division name | Internal Medicine | ||||||
Zip code | 532-0003 | ||||||
Address | 2F Shin-Osaka Brick Building, 1-6-1, Miyahara, Yodogawa-ku, Osaka-shi, Osaka Japan | ||||||
TEL | 06-6398-0203 | ||||||
Homepage URL | https://dmclinic.jp | ||||||
fukuda@drmog.jp |
Sponsor | |
Institute | Fukuda Clinic |
Institute | |
Department |
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 | Japan Physicians Association Institutional Review Board |
Address | Tokyo Medical Association Building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo, 101-0062, Japan |
Tel | 03-3259-6177 |
irb@nichirinnai.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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 90 |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | This study retrospectively collects the medical records in patients with type 2 diabetes who received anagliptin / metformin hydrochloride combination tablets in Fukuda Clinic, and evaluates the clinical outcomes. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047914 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |