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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000024001 |
Receipt No. | R000027609 |
Scientific Title | A randomized comparison of the effect of empagliflozin for endothelial function in type 2 diabetes |
Date of disclosure of the study information | 2016/09/12 |
Last modified on | 2019/04/17 |
Basic information | ||
Public title | A randomized comparison of the effect of empagliflozin for endothelial function in type 2 diabetes | |
Acronym | The effect of empagliflozin for endothelial function | |
Scientific Title | A randomized comparison of the effect of empagliflozin for endothelial function in type 2 diabetes | |
Scientific Title:Acronym | The effect of empagliflozin for endothelial function | |
Region |
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Condition | ||
Condition | Type 2 diabetes | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the effect of empagliflozin for endothelial function in type 2 diabetes. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Change of FMD% with additional treatment before and after 12 weeks |
Key secondary outcomes | 1.Change of them with additional treatment before and after 12 weeks
Fasting plasma glucose Postprandial plasma glucose HbA1c GA Fasting CPR Renal function Urinary albumin L-FABP UA Body weight Waist BMI Blood pressure Heart rate Lipid profile(TC, TG, HDL-C, LDL-C) Body domposition(Body fluid volume, Skeletal muscle mass, Total fat mass) 2.Adverese event |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Empagliflozin group:
Metformin and glargine before bedtime for 12 weeks, then empagliflozin 10 mg was added for 12 weeks. FMD was measured before and after additional treatment. |
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Interventions/Control_2 | Glimepiride group:
Metformin and glargine before bedtime for 12 weeks, then glimepiride 0.5 mg was added for 12 weeks. FMD was measured before and after additional treatment. |
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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.Inpatients with Type 2 diabetes at Chigasaki municipal hospital
2.Patients treated with metformin and basal insulin in leaving hospital 3.Age lower limit 20, upper limit 80 4.BMI <= 45 kg/m2 5.Patients gave written consent to participate in this study |
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Key exclusion criteria | 1.Patients with severe renal dysfunction (eGFR < 45 ml/min/1.73m2)
2.Patients with severe liver dysfunction 3.Patients have history of cardiovascular disease and cerebral infarction within 24 weeks 4.Patients taking steroid 5.Patients with cancer 6.Patients with severe infection and trauma 7.Patients are pregnant or have possibility of pregnancy 8.Patients have an allergy to empagliflozin, glimepiride, glargine and metformin 9.Patients considered inappropriate to participate in this study by the doctor in charge |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chigasaki Municipal Hospital | ||||||
Division name | Division of Endocrinology & Metabolism | ||||||
Zip code | 2530042 | ||||||
Address | 5-15-1, Honson, Chigasaki, Kanagawa | ||||||
TEL | 0467-52-1111 | ||||||
shinobu@medical.email.ne.jp |
Public contact | |||||||
Name of contact person |
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Organization | Chigasaki Municipal Hospital | ||||||
Division name | Division of Endocrinology & Metabolism | ||||||
Zip code | 2530042 | ||||||
Address | 5-15-1, Honson, Chigasaki, Kanagawa | ||||||
TEL | 0467-52-1111 | ||||||
Homepage URL | |||||||
t166054a@yokohama-cu.ac.jp |
Sponsor | |
Institute | Chigasaki Municipal Hospital |
Institute | |
Department |
Funding Source | |
Organization | None |
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 | Chigasaki Municipal Hospital |
Address | 5-15-1, Honson, Chigasaki, Kanagawa |
Tel | 0467-52-1111 |
shinobu@medical.email.ne.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 | 茅ヶ崎市立病院(神奈川県) |
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 | |
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 | Open public 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 |
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=R000027609 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |