Unique ID issued by UMIN | UMIN000039635 |
---|---|
Receipt number | R000045194 |
Scientific Title | 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 |
Date of disclosure of the study information | 2020/03/24 |
Last modified on | 2021/06/08 16:19:11 |
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
Suglat-AID
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
Suglat-AID
Japan |
type 1 diabetes
Endocrinology and Metabolism |
Others
NO
This study aims to determine whether the fasting glucagon levels and the glucagon response to ingestion of a mixed meal are altered after administration of ipragliflozin as an adjunctive therapy to insulin treatment in patients with T1D. We will also investigate whether the glucagon responses under ipragliflozin treatment are associated with amelioration/deterioration in glycemic control and variability.
Safety,Efficacy
Exploratory
Not applicable
Change in fasting glucagon levels and glucagon responses to ingestion of a mixed meal between baseline and 12 weeks after the administration of ipragliflozin
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
24
1st name | Norio |
Middle name | |
Last name | Abiru |
Nagasaki University Hospital
Department of Endocrinology and Metabolism
852-8501
1-7-1 Sakamoto Nagasaki, Japan
095-819-7262
abirun@nagasaki-u.ac.jp
1st name | Ichiro |
Middle name | |
Last name | Horie |
Nagasaki University Hospital
Department of Endocrinology and Metabolism
852-8501
1-7-1 Sakamoto Nagasaki, Japan
095-819-7262
horie@nagasaki-u.ac.jp
Nagasaki University Hospital
Astellas Pharma Inc.
Profit organization
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
Minami Diabetes Clinical Research Center
Department of Pathophysiology and Therapeutics of Diabetic Vascular Complications, Kurume University School of Medicine
The Clinical Research Review Board in Nagasaki University
1-7-1 Sakamoto Nagasaki-shi, Nagasaki-ken
095-819-7905
gaibushikin@ml.nagasaki-u.ac.jp
NO
2020 | Year | 03 | Month | 24 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 03 | Month | 23 | Day |
2020 | Year | 03 | Month | 24 | Day |
2020 | Year | 06 | Month | 01 | Day |
2022 | Year | 06 | Month | 30 | Day |
2022 | Year | 07 | Month | 31 | Day |
2022 | Year | 12 | Month | 31 | Day |
(1) Patient background:inital of patient, diagnosis of T1DM(Type 1A or Type 1B), sex, DoB, hight, body weight, diabetic complications(retinopathy, nephropathy,neuropathy), past histry, duration of diabetes, mediacal history of daibetes
(2) Meal tolerant test(4weeks before and 12weeks after ipragliflozin treatment): Plasma level of glucose, C-peptide, glucagon, IRI, total ketone body, beta-hydroxybutyrate, AGE-related proteins, insulin antobody
(3)Every visits: body weight, CBC, biochemical test(including HbA1c), urine test(including keton body), beta-hydroxybutyrate, %time in range and %time below range for last 4weeks by isCGM, self-monitoring of beta-hydroxybutyrate, adverse events
2020 | Year | 02 | Month | 28 | Day |
2021 | Year | 06 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045194