Study of glucagon response and its association with glycemic control and variability after administration of ipragliflozin as an adjunctive to insulin treatment in patients with type 1 diabetes (Suglat-AID): a single-arm, multicenter, open-label,prospective exploratory trial
- Conditions
- type 1 diabetes
- Registration Number
- JPRN-UMIN000039635
- Lead Sponsor
- agasaki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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