Diabetes mellitus Diabetes mellitus
Conditions
Interventions
The protocol treatment period is from the start of switching from sitagliptin to ipragliflozin until the end of 24 weeks after the start of administration of ipraglifrozin.
The subjects should start a
sitagliptin, ipragliflozin, Diabetes
Sponsors
Ishihara Hisamitsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the requirements listed below must be met for inclusion in the study. 1) Outpatients aged 20 - 74 years with type 2 diabetes mellitus. 2) Patients who provided written informed consent. 3) Patients receiving sitagliptin 50 mg daily and a fixed dose of metformin for more than 16 weeks before registration/enrollment. 4) Patients with HbA1c equal to or more than 7.5% and equal to or less than 9.0% at registration/enrollment. 5) Patients whose difference in HbA1c levels between two visits (registration/enrollment and 4 weeks before registration/enrollment) is within 0.5%. 6) Patients with BMI equol or more than 25.0 kg/m2 at registration/enrollment.
Exclusion criteria
Exclusion criteria: If any of the following conditions applies, the individual will be excluded. 1) Patients with type 1 diabetes mellitus. 2) Patients who had used SGLT2 inhibitors, GLP-1 receptor agonists, sulfonylureas, glinide agents, alpha-glucosidase inhibitors, thiazolidinediones, DPP-4 inhibitors other than sitagliptin at a dose of 50 mg/day or insulin products within 18 weeks before registration/enrolment. 3) Patients with any symptoms of dysuria, anuria, oliguria, or urinary retention. 4) Patients with moderate or worse renal insufficiency (eGFR less than 60 mL/min/1.73 m2). 5) Patients with complications or a history of medically significant kidney disorders including renal vascular disorder, nephrectomy, or kidney transplantation, etc. 6) Patients with a history of recurrent urinary tract infections. 7) Patients with symptomatic urinary tract infections or symptomatic genital infections. 8) Patients with a history of an allergy to ipragliflozin, metformin or sitagliptin. 9) Patients with severe hepatic impairment. 10) Pregnant, possibly pregnant, or lactating women. 11) Male or premenopausal female patients who is unable or unwilling to use appropriate contraception. 12) Patients with severe infection or serious trauma, or perioperative patients. 13) Patients with drug addiction or alcohol abuse. 14) Patients judged by the principal investigator or sub-investigator to be unsuitable for participants in the study. to use appropriate contraception. 12) Patients with severe infection or serious trauma, or perioperative patients. 13) Patients with drug addiction or alcohol abuse. 14) Patients judged by the principal investigator or sub-investigator to be unsuitable for participants in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from the baseline in HbA1c at the end of administration or at the time of discontinuation after switching | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from the baseline in the following parameters at each time point (8, 16, and 24 weeks after switching or at the time of discontinuation). 1) glycemic parameters. HbA1c (except for 24 weeks after switching), fasting plasma glucose level, fasting serum insulin level, c-peptide level, HOMA-IR (homeostasis model assessment as an index of Insulin Resistance) index, HOMA-beta (homeostasis model assessment of beta cell function) index. 2) body weight. 3) Percentage of patients who achieved HbA1c < 7.0% and < 6.5%. | — |
Contacts
Public ContactHisamitsu Ishihara
Nihon University Itabashi Hospital
Outcome results
None listed