type 1 diabetes
Conditions
Interventions
None listed
Sponsors
Nagasaki University Hospital
Metabolic Signal Research Center, Institute for Molecular and Cellular Regulation, Gunma University Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Hyogo College of Medicine Division of Diabetes and Endocrinology, Kumamoto Central Hospital The Department of Internal Medicine Division of Diabetes Endocrinology, Showa University Hospital Department of Interanl Medicine, Division of Diabetes and Endocrinology, Kobe University Graduate School of Medicine Min
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be required to meet all of the following inclusion criteria: (1) Diagnosed with T1D by diabetologists based on the criteria of T1D defined by the Japan Diabetes Society. (2) Indicated for ipragliflozin as an adjunctive to insulin therapy due to an inability to achieve a good level of glycemic control (HbA1c >7.5%) despite receiving intensive insulin therapy with the use of isCGM. (3) Confirmed to have absolute insulin deficiency as defined by a fasting C-peptide concentration <0.6 ng/mL and/or an increment of C-peptide levels <0.6 ng/mL during the glucagon challenge test. (4) Using an isCGM system with FreeStyle Libre. (5) Outpatients. (6) Willingness to provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients with any of the following will be excluded: (1) Use of any SGLT2 inhibitors within 12 months before enrollment. (2) A previous history of ketoacidosis within 12 months before enrollment. (3) An eating disorder. (4) Regular consumption of a low-carbohydrate diet. (5) Alcohol abuse or alcohol consumption >20 g/day. (6) Severe renal dysfunction defined as an estimated glomerular filtration rate <30 mL/min/1.73m2. (7) Severe anemia defined as a hemoglobin level <10 g/dL. (8) Hypersensitivity or allergy to SGLT2 inhibitors including ipragliflozin. (9) Body mass index (BMI) <20.0 kg/m2. (10) Previous history of repeated severe hypoglycemia, urinary tract infection or genital infection. (11) Pregnancy or breastfeeding. (12) HbA1c levels >11% at enrollment. (13) Judged inappropriate to participate by the study investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting glucagon levels and glucagon responses to ingestion of a mixed meal between baseline and 12 weeks after the administration of ipragliflozin | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the following items from baseline to 12 weeks after the administration of ipragliflozin; body weight, glycated hemoglobin (HbA1c), glycated albumin (GA), the required daily dose of insulin, values obtained from the mixed meal tolerance test (MMTT), albuminuria, advanced glycation end products (AGEs), diacron-reactive oxygen metabolites (d-ROMs), the glucose values (mean amplitude of glycemic excursions (MAGE) and the percentage of time in the targeted range (TIR; glucose levels 70-180 mg/dL), time below range (TBR; glucose levels <70 mg/dL), time above range (TAR; glucose levels >180 mg/dL)) obtained from the intermittently scanned continuous glucose monitoring (isCGM) system with FreeStyle Libre, the levels of serum beta-hydroxybutyrate, frequency of development of ketosis, all adverse events | — |
Countries
Japan
Contacts
Public ContactIchiro Horie
Nagasaki University Hospital Department of Endocrinology and Metabolism
Outcome results
None listed