Tofogliflozin GLP-1 Analogue Combination Trial

Kowa

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: GLP-1 analogue; Drug: Tofogliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537834

TOFOGL07279 (Other Identifier)

DEBT02

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Tofogliflozin ＋GLP-1 analogue

Experimental group

Description:

Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.

Treatment:

Drug: GLP-1 analogue

Drug: Tofogliflozin