CompletedPhase 4

Tofogliflozin GLP-1 Analogue Combination Trial

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

Lead sponsor

Kowa Company, Ltd.

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•HbA1c 7.5-10.5%

Primary endpoints

•Safety and Tolerability•HbA1c

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02537834

Org study IDDEBT02

Secondary IDTOFOGL07279Sanofi

Timeline

Milestones

Study first posted2015-09-02estimated

Last update posted2020-11-17actual

Study start2015-08 (month precision)

Primary completion2017-07actual (month precision)

Study completion2017-10actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight

Time frame:baseline and week 52