Condition or disease | Intervention/treatment | Phase |
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Insulin Resistance - Type A Insulin Resistance - Type B Lipoatrophic Diabetes Mellitus Insulin Resistance Syndrome | Drug: Empagliflozin Tablets | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Open-label, Single-arm Study With Regard to the Efficacy and Safety of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance |
Actual Study Start Date : | September 1, 2019 |
Estimated Primary Completion Date : | July 31, 2021 |
Estimated Study Completion Date : | October 30, 2021 |
Arm | Intervention/treatment |
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Experimental: Treatment of empagliflozin
Empagliflozin 10 mg is to be continuously administered once daily for 12 weeks. Measure an HbA1c level after 12 weeks and determine the dose (Week 13 to Week 24). In case of <7.0%, 10 mg will be continued: in case of >=7.0%, it will be increased to 25 mg.
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Drug: Empagliflozin Tablets
The administration is oral administration with water before or after breakfast.
Other Name: BI10773
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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Kobe University Hospital | |
Kobe, Hyogo, Japan, 650-0017 | |
Tohoku University Hospital | |
Sendai, Miyagi, Japan, 980-8574 | |
Jichi Medical University Hospital | |
Shimotsuke, Tochigi, Japan, 329-0498 | |
NIhon University Hospital | |
Chiyoda-ku, Tokyo, Japan, 101-8309 | |
Okayama University Hospital | |
Okayama, Japan, 700-8558 |
Study Chair: | Wataru Ogawa | Kobe University Hospital |
Tracking Information | |||||||
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First Submitted Date ICMJE | July 10, 2019 | ||||||
First Posted Date ICMJE | July 12, 2019 | ||||||
Last Update Posted Date | March 3, 2021 | ||||||
Actual Study Start Date ICMJE | September 1, 2019 | ||||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
HbA1c change at Week 24 of the treatment from baseline [ Time Frame: at Week 24 of the treatment from baseline ] With regard to the HbA1c change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance | ||||||
Official Title ICMJE | A Multicenter, Open-label, Single-arm Study With Regard to the Efficacy and Safety of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance | ||||||
Brief Summary | A multicenter, open-label, single-arm study with regard to the efficacy and safety of empagliflozin in patients with refractory diabetes mellitus with insulin resistance | ||||||
Detailed Description | To evaluate the clinical efficacy of a treatment with empagliflozin in refractory diabetes mellitus patients with insulin resistance (insulin resistance syndrome, lipoatrophic diabetes mellitus) by using the HbA1c change at Week 24 of treatment from baseline | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Empagliflozin Tablets
The administration is oral administration with water before or after breakfast.
Other Name: BI10773
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Study Arms ICMJE | Experimental: Treatment of empagliflozin
Empagliflozin 10 mg is to be continuously administered once daily for 12 weeks. Measure an HbA1c level after 12 weeks and determine the dose (Week 13 to Week 24). In case of <7.0%, 10 mg will be continued: in case of >=7.0%, it will be increased to 25 mg.
Intervention: Drug: Empagliflozin Tablets
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
8 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | October 30, 2021 | ||||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Japan | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04018365 | ||||||
Other Study ID Numbers ICMJE | 190012 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Wataru Ogawa, Kobe University | ||||||
Study Sponsor ICMJE | Kobe University | ||||||
Collaborators ICMJE | Boehringer Ingelheim | ||||||
Investigators ICMJE |
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PRS Account | Kobe University | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |