Clincosm LogoSign in Get a demo

Tofogliflozin GLP-1 Analogue Combination Trial

Sponsor
Kowa Company, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02537834
Collaborator
Sanofi (Industry)
65
Enrollment
11
Locations
1
Arm
26
Duration (Months)
5.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tofogliflozin ＋GLP-1 analogue

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

Drug: Tofogliflozin
Other Names:
  • DEBERZA
  • APLEWAY

    • Drug: GLP-1 analogue

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction [baseline and Week 52]

    2. Change from Baseline in HbA1c at 52 weeks [Week 52]

    Secondary Outcome Measures

    1. Change in Fasting plasma glucose [baseline and week 52]

    2. Change in Body Weight [baseline and week 52]

    3. Change in Blood pressure [baseline and week 52]

    4. Change in Uric Acid [baseline and week 52]

    5. Change in Total cholesterol [baseline and week 52]

    6. Change in HDL-C [baseline and week 52]

    7. Change in LDL-C [baseline and week 52]

    8. Change in non HDL-C [baseline and week 52]

    9. Change in Free Fatty Acid [baseline and week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atsuta-ku Aichi Japan 456-0058
    2 Minato-ku Aichi Japan 455-0018
    3 Kisarazu Chiba Japan 292-0038
    4 Annaka Gunma Japan 379-0116
    5 Naka Ibaraki Japan 311-0113
    6 Sagamihara Kanagawa Japan 252-0302
    7 Kasaoka Okayama Japan 714-0043
    8 Shimono Tochigi Japan 329-0433
    9 Adachi-ku Tokyo Japan 123-0845
    10 Chuo-ku Tokyo Japan 103-0027
    11 Mitaka Tokyo Japan 181-0013

    Sponsors and Collaborators

    • Kowa Company, Ltd.
    • Sanofi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kowa Company, Ltd.
    ClinicalTrials.gov Identifier:
    NCT02537834
    Other Study ID Numbers:
    • DEBT02
    • TOFOGL07279
    First Posted:
    Sep 2, 2015
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Nov 1, 2020
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol

    Study Results

    No Results Posted as of Nov 17, 2020