Tofogliflozin GLP-1 Analogue Combination Trial

Study Overview
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Brief Summary
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An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.

Official Title
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An Open-Label, Multicenter Study to Evaluate 52-Week Long-Term Safety, Tolerability and Efficacy of Tofogliflozin With Glucagon-like Peptide-1(GLP-1) Analogue Treatment In Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Tofogliflozin
* Drug: GLP-1 analogue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject aged from 20 to 75 years old with type 2 diabetes mellitus(T2DM) The subject with hemoglobin A1c ≧7.5% - <10.5 % The subject who has been receiving a stable dose and regimen of GLP-1 analogue over 8 weeks before Screening test Exclusion Criteria: The subject with type 1 diabetes mellitus The subject with Pregnancy or lactation The subject with Fasting Plasma Glucose ≧ 270 mg/dl The subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening The subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months The subject with serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women The subject with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times the upper limit of the reference range at the central laboratory test facility The subject has received treatment with another investigational product or non-approved drug 3 months before screening The subject with history of Tofogliflozin therapy The subject with estimated glomerular filtration rate of <30 mL/min/1.73 m^2 The subject who frequently experiencing orthostatic hypotension The subject systolic blood pressure of ≧ 180 or mmHg of diastolic blood pressure of ≧ 100 mmHg The subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : Lipid-lowering drug , Antihypertensive drug, Thyroid hormone drug , Uric acid lowering drug

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tofogliflozin ＋GLP-1 analogue<br>Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment. | Drug: Tofogliflozin<br> <br> * Other names: APLEWAY;Drug: GLP-1 analogue<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction |  | baseline and Week 52 | 
| Change from Baseline in HbA1c at 52 weeks |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting plasma glucose |  | baseline and week 52 | 
| Change in Body Weight |  | baseline and week 52 | 
| Change in Blood pressure |  | baseline and week 52 | 
| Change in Uric Acid |  | baseline and week 52 | 
| Change in Total cholesterol |  | baseline and week 52 | 
| Change in HDL-C |  | baseline and week 52 | 
| Change in LDL-C |  | baseline and week 52 | 
| Change in non HDL-C |  | baseline and week 52 | 
| Change in Free Fatty Acid |  | baseline and week 52 |