Study of Ipragliflozin in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Post-marketing Clinical Study of Ipragliflozin; Multicenter, Open-label Study to Assess the Efficacy of Ipragliflozin Add-on in Reducing Insulin Dose in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847091
• Other study ID #: 1941-MA-3054
• Status: Completed
• Phase: Phase 4
• Start date: July 29, 2016
• Est. completion date: November 9, 2017

Study information

• Verified date: December 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 9, 2017
• Est. primary completion date: November 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• The subject has been receiving insulin therapy for the treatment of diabetes mellitus.

• The subject has type 2 diabetes mellitus and has been receiving insulin monotherapy or insulin therapy in combination with one or two oral hypoglycemic agents.

• The subject has not modified diet or exercise therapies or dosage regimen of oral hypoglycemic agents, or has not switched to another pharmacotherapy for 12 weeks before Visit 1.

• The subject has an HbA1c value between 6.5% and <8.0%.

• The subject has a body mass index (BMI) of >23.0 kg/m2.

• 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 post-menopausal (absence of menses for at least 1 year).

• The subject is surgically sterile.

The subject is of childbearing potential but satisfies all of the following criteria:

• The subject agrees not to get pregnant to 28 days after the last dose of the study drug.

• 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.

• If the subject is a female, she must agree not to breastfeed to 28 days after the last dose of the study drug.

• If the subject is a female, she must agree not to donate their eggs during the period from the assessment to 28 days after the last dose of the study drug.

• In case a male subject's spouse or partner is of childbearing potential, the subject must agree to use two of the established contraceptive methods to 28 days after the last dose of the study drug.

• If the subject is a male, he must agree not to donate their sperm to 28 days after the last dose of the study drug.

Exclusion Criteria:

• The subject has type 1 diabetes mellitus.

• The subject has any symptom of dysuria, anuria, oliguria or urinary retention.

• The subject has proliferative retinopathy.

• The subject has diabetic ketoacidosis.

• The subject has a history or complication of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.

• The subject has a history of recurrent urinary tract infection.

• The subject has symptomatic urinary tract infection or symptomatic genital infection.

• The subject has chronic disease(s) that require the continuous use of corticosteroids, immunosuppressants, etc.

• The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and serious heart disease within 1 year (52 weeks) before signing of the informed consent.

• The subject has a complication or surgical history of serious gastrointestinal disorder.

• The subject has severe hepatic dysfunction.

• The subject has uncontrolled blood pressure.

• The subject has unstable psychiatric disorder.

• The subject has severe infection or serious trauma, or perioperative.

• The subject has drug addiction or alcohol abuse.

• The subject has a history of malignant tumors.

• The subject has a history of an allergy to ipragliflozin and/or similar drugs (drugs possessing SGLT2 inhibitory action).

• The subject has used SGLT2 inhibitors, GLP-1 receptor agonists, sulfonylureas (SU), glinide agents, or insulin products other than long-acting insulin within 12 weeks before signing of the informed consent.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Ipragliflozin
Oral administration, 50mg once daily
• Insulin
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).

Locations

Country	Name	City	State
Japan	Site JP00007	Gunma
Japan	Site JP00008	Hiroshima
Japan	Site JP00009	Hyogo
Japan	Site JP00010	Kanagawa
Japan	Site JP00003	Mie
Japan	Site JP00004	Osaka
Japan	Site JP00015	Shiga
Japan	Site JP00002	Tochigi
Japan	Site JP00005	Tochigi
Japan	Site JP00013	Tochigi
Japan	Site JP00001	Tokyo
Japan	Site JP00006	Tokyo
Japan	Site JP00011	Tokyo
Japan	Site JP00012	Tokyo
Japan	Site JP00014	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in insulin dose		Baseline and Week 24
Primary	Percent change from baseline in insulin dose		Baseline and Week 24
Secondary	Change from baseline in insulin dose		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)
Secondary	Percent change from baseline in insulin dose		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)
Secondary	Change from baseline in HbA1c		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)
Secondary	Change from baseline in fasting plasma glucose		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)
Secondary	Change from baseline in cholesterol		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)
Secondary	Change from baseline in glycoalbumin		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)
Secondary	Change from baseline in leptin		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)
Secondary	Change from baseline in adiponectin		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)
Secondary	Change from baseline in glucagon		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)
Secondary	Change from baseline in C-peptide		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)
Secondary	Change from baseline in body weight		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)
Secondary	Change from baseline in waist circumference		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)
Secondary	Change from baseline in blood pressure		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)
Secondary	Change from baseline in DTSQ	DTSQ: Diabetes treatment satisfaction questionnaire	Baseline and Week 24 and the last assessment during the treatment period (up to Week 24)
Secondary	Number of subjects achieving withdrawal of insulin therapy		Up to Week 24
Secondary	Percent of subjects achieving withdrawal of insulin therapy		Up to Week 24
Secondary	Safety assessed by incidence of Adverse events		Up to Week 24
Secondary	Safety assessed by blood pressure in a sitting position		Up to Week 24
Secondary	Safety assessed by pulse rate in a sitting position		Up to Week 24
Secondary	Safety assessed by Hematology		Up to Week 24
Secondary	Safety assessed by biochemistry		Up to Week 24

External Links

•   Link to results on the Astellas Clinical Study Results website