Tofogliflozin GLP-1 Analogue Combination Trial

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Tofogliflozin; Drug: GLP-1 analogue

• Registration Number: NCT02537834
• Lead Sponsor: Kowa Company, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Primary Completion: 2017-07
• Study Completion: 2017-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-15
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tofogliflozin ＋GLP-1 analogue	GLP-1 analogue	Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.
Tofogliflozin ＋GLP-1 analogue	Tofogliflozin	Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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