A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.

Detailed Description
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This study consists of two parts. First part is a placebo-controlled multicenter, double-blind, parallel group study, in which subjects will receive ipragliflozin or placebo once daily in combination with an insulin preparation for 16 weeks. Second part is a multicenter, open-label period (36 weeks) with no placebo group. The dose of ipragliflozin can be doubled in combination with an insulin preparation during the second part.

Official Title
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Postmarketing Clinical Study of Ipragliflozin - Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: ipragliflozin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been diagnosed with type 2 diabetes mellitus for at least 12 weeks (84 days) at signing of informed consent. Subject takes constant dosage and administration of insulin preparation for more than 6 weeks (42 days) Subject has an HbA1C value between 7.5 and 10.0% at Visit 2 and the difference of HbA1C value within ± 1.0% between Visit 1 and Visit 2 Subject has a body mass index (BMI) 20.0 - 45.0 kg/m2 Exclusion Criteria: Subject has type 1 diabetes mellitus Subject has proliferative diabetic retinopathy Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant Subject has a history of recurrent urinary tract infection (more than three times within before 24 weeks of obtaining informed consent) Subject has a symptomatic urinary tract infection or symptomatic genital infection Subject has chronic disease which requires the continuous use of adrenocortical steroids and immunosuppressant (oral medication, injection, or inhalation) Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1 Subject has unstable psychiatric disorder Female subject who is currently pregnant or lactating, or who is possibly pregnant Male and pre-menopausal female subject who cannot use an appropriate contraception during the study Subject has severe infection, perioperative, or serious trauma Subject has drug addiction or alcohol abuse Subject has a history of malignant tumors (except for those who have not received treatment for malignant tumors for at least 5 years before informed consent acquisition and was not considered to have recurrence) Subject has a history of an allergy with ipragliflozin and/or similar drugs (study drugs possessing SGLT 2 inhibitory action) Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies Subject is unable, unwilling to adhere to compliances such as hospital visits and dose instruction specified in this study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ipragliflozin group<br>oral | Drug: ipragliflozin<br>* oral<br>* Other names: Suglat;|
| Experimental: placebo group<br>oral | Drug: placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C from baseline |  | Baseline and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  | Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | 
| Leptin concentration |  | Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52 | 
| Fructosamine concentration |  | Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52 | 
| Adiponectin concentration |  | Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52 | 
| Body weight |  | Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | 
| Waist circumference |  | Baseline, Week 16, 24, 52 | 
| Blood glucose values of self monitoring | written in a diary | Baseline, Week 8, 16, 24, 52 | 
| Safety assessed by the adverse events, vital signs. and laboratory tests |  | Up to 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose, insulin, ipragliflozin, SGLT2 inhibitor