UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public 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
Acronym
Suglat-AID
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
Scientific Title:Acronym
Suglat-AID
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in fasting glucagon levels and glucagon responses to ingestion of a mixed meal between baseline and 12 weeks after the administration of ipragliflozin
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Abiru |
Organization
Nagasaki University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto Nagasaki, Japan
TEL
095-819-7262
abirun@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto Nagasaki, Japan
TEL
095-819-7262
Homepage URL
horie@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical Research Review Board in Nagasaki University
Address
1-7-1 Sakamoto Nagasaki-shi, Nagasaki-ken
Tel
095-819-7905
gaibushikin@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
(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
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045194
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