NCT04018365UnknownPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Kobe University
- Enrollment
- 8
- Locations
- 5
- Primary Endpoint
- HbA1c change at Week 24 of the treatment from baseline
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A patient who has been diagnosed with insulin resistance syndrome (type A, type B, type non-A non-B) or lipoatrophic diabetes mellitus prior to obtaining consent
- •A patient who has received consistent dosage and administration of drugs aiming a hypoglycemic effect and consistent instructions of diet therapy/exercise therapy for more than 12 weeks before enrollment
- •A patient with >= 7.0 % of HbA1c at the time of screening
- •A patient, if taking other SGLT2 inhibitor than empagliflozin, whose SGLT2 inhibitor can be washed out for more than 12 weeks prior to starting empagliflozin
- •A patient at the age of >=20 years at the time of consent
- •A patient who has received sufficient explanation with regard to information such as the objectives and details of this study, expected drug efficacy/pharmacological action, and risks, and has given written consent by her/himself.
Exclusion Criteria
- •A patient with a medical history of acute coronary syndrome (including non-ST-elevation myocardial infarction, ST-elevation myocardial infarction, and unstable angina pectoris), stroke or transient ischemic attack (TIA) within 3 months before obtaining consent
- •A patient with suspected hepatic dysfunction, that either of serum ALT, AST or alkaline phosphatase in the screening period is exceeding 3-fold of upper limit of normal rang
- •A patient who is receiving a systemic steroid at the time of consent (except for type B)
- •A patient whose thyroid hormone product dose has been changed within 6 weeks before obtaining consent
- •A patient with unstable endocrine diseases other than diabetes mellitus
- •A patient with hemolysis or blood diseases that destabilize erythrocytic cells and other various disorders (e.g., malaria, babesiosis, hemolytic anemia).
- •A premenopausal female patient (the latest menstruation was within 1 year before obtaining consent), a lactating or pregnant patient, or a patient who may be pregnant (without hysterectomy or ovariectomy) who has no intention to use efficacious contraception defined in this study during the treatment period and would not agree to receive regular pregnancy tests during the treatment period
- •A patient who has experienced alcohol abuse or drug abuse within 3 months before obtaining consent, which may disturb the study participation
- •A patient who is in the condition that makes it difficult to administer the study drug
- •A patient with renal dysfunction of eGFR (MDRD calculating formula) < 45 mL/min/1.73 m2 in the screening period
- •A patient who indicates a hypersensitivity response to empagliflozin or its excipients, or a patient with lactose-intolerance
- •A patient with severe ketosis, diabetic coma or precoma, severe infection, perioperative status, or serious trauma
- •A patient that the investigator and/or subinvestigator, etc., has judged to be ineligible to this study for other reasons
Arms & Interventions
Treatment of empagliflozin
Experimental
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: Empagliflozin Tablets (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- HbA1c over time(at Week 24 of the treatment from baseline)
- HbA1c change rate at Week 24 of the treatment from baseline(at Week 24 of the treatment from baseline)
- HbA1c change at Week 12 of the treatment from baseline(at Week 12 of the treatment from baseline)
- Fasting plasma glucose (FPG) over time(at Week 24 of the treatment from baseline)
- FPG change at Week 24 of the treatment from baseline(at Week 24 of the treatment from baseline)
- Change of insulin dose(at Week 24 of the treatment from baseline)
- Postprandial glucose for 2 hours over time(2 Weeks from Day0 and Day140)
Investigators
Wataru Ogawa
Professor, Division of Diabetes and Endocrinology
Kobe University
Study Sites (5)
Loading locations...
Similar Trials
Completed
Phase 2
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast CancerChemotherapy-induced NeutropeniaNCT01569087Biocad60
Completed
Phase 3
Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia AHemophilia ANCT03815318Sinocelltech Ltd.73
Not yet recruiting
Phase 1
Surufatinib Combined With Tislelizumab in the Second-line and Further Treatment of Triple-negative Breast CancerMetastatic Triple-negative Breast CancerNCT05746728Huihua Xiong45
Completed
Phase 1
The Pharmacokinetics, and Safety of Brexpiprazole Tablets in Chinese Healthy SubjectsHealthyNCT03734302Otsuka Beijing Research Institute10
Unknown
Not Applicable
Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of GERDGERDNCT02759094Implantica CE Reflux Ltd.50