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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04018365
Other study ID # 190012
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 1, 2019
Est. completion date October 30, 2021

Study information

Verified date March 2021
Source Kobe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 8
Est. completion date October 30, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - 1) 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 - 2) 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 - 3) A patient with >= 7.0 % of HbA1c at the time of screening - 4) 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 - 5) A patient at the age of >=20 years at the time of consent - 6) 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: - 1) 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 - 2) 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 - 3) A patient who is receiving a systemic steroid at the time of consent (except for type B) - 4) A patient whose thyroid hormone product dose has been changed within 6 weeks before obtaining consent - 5) A patient with unstable endocrine diseases other than diabetes mellitus - 6) A patient with hemolysis or blood diseases that destabilize erythrocytic cells and other various disorders (e.g., malaria, babesiosis, hemolytic anemia). - 7) 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 - 8) A patient who has experienced alcohol abuse or drug abuse within 3 months before obtaining consent, which may disturb the study participation - 9) A patient who is in the condition that makes it difficult to administer the study drug - 10) A patient with renal dysfunction of eGFR (MDRD calculating formula) < 45 mL/min/1.73 m2 in the screening period - 11) A patient who indicates a hypersensitivity response to empagliflozin or its excipients, or a patient with lactose-intolerance - 12) A patient with severe ketosis, diabetic coma or precoma, severe infection, perioperative status, or serious trauma - 13) A patient that the investigator and/or subinvestigator, etc., has judged to be ineligible to this study for other reasons

Study Design


Intervention

Drug:
Empagliflozin Tablets
The administration is oral administration with water before or after breakfast.

Locations

Country Name City State
Japan NIhon University Hospital Chiyoda-ku Tokyo
Japan Kobe University Hospital Kobe Hyogo
Japan Okayama University Hospital Okayama
Japan Tohoku University Hospital Sendai Miyagi
Japan Jichi Medical University Hospital Shimotsuke Tochigi

Sponsors (2)

Lead Sponsor Collaborator
Kobe University Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c change 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. at Week 24 of the treatment from baseline
Secondary HbA1c change rate at Week 24 of the treatment from baseline With regard to the HbA1c change rate at Week 24 of the treatment from baseline, change rates will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum. at Week 24 of the treatment from baseline
Secondary HbA1c change at Week 12 of the treatment from baseline With regard to the HbA1c change at Week 12 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. at Week 12 of the treatment from baseline
Secondary HbA1c over time The HbA1c level at measurement time point is tabulated by patient, as well as plotting the HbA1c level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of HbA1c at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph. at Week 24 of the treatment from baseline
Secondary Fasting plasma glucose (FPG) over time The FPG level at measurement time point is tabulated by patient, as well as plotting the FPG level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of FPG at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph. at Week 24 of the treatment from baseline
Secondary FPG change at Week 24 of the treatment from baseline With regard to the FPG 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. at Week 24 of the treatment from baseline
Secondary Change of insulin dose The insulin dose of each patient will be tabulated by time point. at Week 24 of the treatment from baseline
Secondary Postprandial glucose for 2 hours over time The postprandial glucose for 2 hours at measurement time point is tabulated by patient, and the glucose level over time is plotted by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of postprandial glucose for 2 hours at each time point will be tabulated, and the mean at each measurement time point with an error bar of standard deviation will be displayed by line graph. 2 Weeks from Day0 and Day140
See also
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Completed NCT03716336 - Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women N/A
Completed NCT03741686 - Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome Phase 2
Recruiting NCT04128969 - Causal Mechanisms in Adolescent Arterial Stiffness Phase 2
Active, not recruiting NCT04221152 - A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 ) Phase 3