A Multicenter, Open-label, Single-arm, Extension Study With Regard to the Safety and Efficacy of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance (EMPIRE-02)
Overview
- Phase
- Phase 3
- Intervention
- Empagliflozin Tablets
- Conditions
- Insulin Resistance - Type A
- Sponsor
- Kobe University
- Enrollment
- 8
- Locations
- 5
- Primary Endpoint
- Adverse events, Adverse drug reactions, and Presence/absence of the use of rescue treatment drugs
- Last Updated
- 4 years ago
Overview
Brief Summary
A multicenter, open-label, single-arm, extension study with regard to the safety and efficacy of empagliflozin in patients with refractory diabetes mellitus with insulin resistance.
Detailed Description
To determine the safety and efficacy of oral administration of empagliflozin 10 mg or 25 mg once daily for 28 weeks (52 weeks of the EMPIRE-01 study) in subjects who participated in the EMPIRE-01 study, which was conducted on refractory diabetes mellitus patients with insulin resistance (insulin resistance syndrome, lipoatrophic diabetes mellitus) in a multicenter, open-label, single-arm, extension study.
Investigators
Wataru Ogawa
Professor, Division of Diabetes and Endocrinology
Kobe University
Eligibility Criteria
Inclusion Criteria
- •A patient who completed the preceding EMPIRE-01 study and does not meet any discontinuation criteria
- •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 is exceeding 3-fold of upper limit of normal range prior to starting extension study treatment (Day 0)
- •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 study period and would not agree to receive regular pregnancy tests during the study 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 prior to starting extension study treatment (Day 0)
Arms & Interventions
Treatment of empagliflozin
The study treatment shall be started from the next day of the Week 24 visit of the EMPIRE-01 study after enrollment. The investigational drug shall be administered at the same dosage as that of the empagliflozin tablet administered from Week 12 to Week 24 of the treatment period in the EMPIRE-01 study. The administration is oral administration with water once daily before or after breakfast.
Intervention: Empagliflozin Tablets
Outcomes
Primary Outcomes
Adverse events, Adverse drug reactions, and Presence/absence of the use of rescue treatment drugs
Time Frame: until Week 28 (Week 52 of the EMPIRE-01 study)
Presence/absence of adverse events, adverse drug reactions, and use of rescue treatment drugs
Secondary Outcomes
- HbA1c change rate at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline(at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline)
- HbA1c change at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline(at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline)
- HbA1c at each time point(at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.)
- Fasting plasma glucose (FPG) at each time point(at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.)
- Fasting plasma glucose (FPG) change at Week 28 (52) of the treatment from baseline(between Week 28 (52) and baseline of the EMPIRE-01 study.)
- Insulin dose at each time point (TDD, TBD)(at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.)
- Postprandial glucose for 2 hours over time(for 14 days starting from Week 12 (36))