A Phase 4 interventional study of Ipragliflozin and Insulin in Type 2 Diabetes Mellitus, sponsored by Astellas Pharma Inc. Completed at 15 sites in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Astellas Pharma Inc · Phase 4, Interventional, and Treatment
The objective of this study is to assess the reduction in insulin dose from baseline at Week 24 while keeping the blood glucose levels controlled (maintaining HbA1c values) when ipragliflozin is administered once daily for 24 weeks in patients with type 2 diabetes mellitus receiving insulin therapy.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 103 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
If the subject is a female, she must satisfy the following criteria. The subject is not of childbearing potential and satisfies any of the following criteria.
The subject is of childbearing potential but satisfies all of the following criteria:
The subject has a negative pregnancy test. The subject agrees to use two of the established contraceptive methods listed below to 28 days after the last dose of the study drug when having heterosexual intercourse.
Exclusion Criteria:
Ipragliflozin will be administered orally for 24 weeks.
Drug: Ipragliflozin · Drug: Insulin
Oral administration, 50mg once daily
Also known as: ASP1941, Suglat
Patients are receiving insulin therapy from at least 12 weeks before Visit 1 (is allowed ±10% dose modification if clinically needed, and is reduced within a 20% to 40% range at Visit 1 and then is controlled up to Visit 8 based on criteria of this study).
Change from baseline in insulin dose
Time frame: Baseline and Week 24
Percent change from baseline in insulin dose
Time frame: Baseline and Week 24
Change from baseline in insulin dose
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and the last assessment during the treatment period (up to Week 24)
Percent change from baseline in insulin dose
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and the last assessment during the treatment period (up to Week 24)
Change from baseline in HbA1c
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in fasting plasma glucose
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in cholesterol
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in glycoalbumin
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in leptin
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in adiponectin
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in glucagon
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in C-peptide
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in body weight
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in waist circumference
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in blood pressure
Time frame: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)
Change from baseline in DTSQ
DTSQ: Diabetes treatment satisfaction questionnaire
Time frame: Baseline and Week 24 and the last assessment during the treatment period (up to Week 24)
Number of subjects achieving withdrawal of insulin therapy
Time frame: Up to Week 24
Percent of subjects achieving withdrawal of insulin therapy
Time frame: Up to Week 24
Safety assessed by incidence of Adverse events
Time frame: Up to Week 24
Safety assessed by blood pressure in a sitting position
Time frame: Up to Week 24
Safety assessed by pulse rate in a sitting position
Time frame: Up to Week 24
Safety assessed by Hematology
Time frame: Up to Week 24
Safety assessed by biochemistry
Time frame: Up to Week 24
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc