NCT02537834
Completed
Phase 4
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
ConditionsType 2 Diabetes Mellitus
Overview
- Phase
- Phase 4
- Intervention
- Tofogliflozin
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Kowa Company, Ltd.
- Enrollment
- 65
- Primary Endpoint
- Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Tofogliflozin ＋GLP-1 analogue
Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.
Intervention: Tofogliflozin
Tofogliflozin ＋GLP-1 analogue
Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.
Intervention: GLP-1 analogue
Outcomes
Primary Outcomes
Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction
Time Frame: baseline and Week 52
Change from Baseline in HbA1c at 52 weeks
Time Frame: Week 52
Secondary Outcomes
- Change in Fasting plasma glucose(baseline and week 52)
- Change in Blood pressure(baseline and week 52)
- Change in Uric Acid(baseline and week 52)
- Change in LDL-C(baseline and week 52)
- Change in Total cholesterol(baseline and week 52)
- Change in non HDL-C(baseline and week 52)
- Change in Free Fatty Acid(baseline and week 52)
- Change in Body Weight(baseline and week 52)
- Change in HDL-C(baseline and week 52)
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