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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: GLP-1 analogue; Drug: Tofogliflozin

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Atsuta-ku, Aichi, Japan, 456-0058
    • Minato-ku, Aichi, Japan, 455-0018
  • Chiba
    • Kisarazu, Chiba, Japan, 292-0038
  • Gunma
    • Annaka, Gunma, Japan, 379-0116
  • Ibaraki
    • Naka, Ibaraki, Japan, 311-0113
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0302
  • Okayama
    • Kasaoka, Okayama, Japan, 714-0043
  • Tochigi
    • Shimono, Tochigi, Japan, 329-0433
  • Tokyo
    • Adachi-ku, Tokyo, Japan, 123-0845
    • Chuo-ku, Tokyo, Japan, 103-0027
    • Mitaka, Tokyo, Japan, 181-0013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tofogliflozin ＋GLP-1 analogue; Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.	Drug: GLP-1 analogue; Drug: Tofogliflozin; Other Names: DEBERZA; APLEWAY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Kowa Company, Ltd.
• Collaborators: Sanofi

Publications and helpful links

General Publications

• Terauchi Y, Fujiwara H, Kurihara Y, Suganami H, Tamura M, Senda M, Gunji R, Kaku K. Long-term safety and efficacy of the sodium-glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week open-label, multicenter, post-marketing clinical study. J Diabetes Investig. 2019 Nov;10(6):1518-1526. doi: 10.1111/jdi.13066. Epub 2019 May 28.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): October 1, 2017

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (ESTIMATE): September 2, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 15, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
• Other Study ID Numbers: DEBT02; TOFOGL07279 (OTHER: Sanofi)