Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

TOFO Insulin Combination Trial

Lead Sponsor:

Sanofi

Collaborating Sponsors:

Kowa Company, Ltd.

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

20-75 years

Phase:

PHASE4

Brief Summary

Primary Objectives: To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction o...

Detailed Description

The total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an ope...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM).
  • Hemoglobin A1c ≥7.5% - ≤10.5% and FPG ≤220 mg/dL.
  • Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening.
  • Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening.
  • Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen.
  • Body mass index (BMI) ≥18.5 kg/m\^2 and \<35.0 kg/m\^2.
  • No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.
  • Exclusion criteria:
  • Type 1 diabetes mellitus.
  • Pregnancy or lactation.
  • Severely uncontrolled glycemic situation.
  • History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening.
  • History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months.
  • A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of the reference range at the central laboratory test facility.
  • Has previously received treatment with the investigational product.
  • Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment.
  • Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical \[skin\] application, eye drops and sprays).
  • Patients who are frequently experiencing orthostatic hypotension.
  • Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment:
  • Lipid-lowering drug
  • Antihypertensive drug
  • Thyroid hormone preparation
  • Uric acid lowering drug
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    June 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2016

    Estimated Enrollment :

    211 Patients enrolled

    Trial Details

    Trial ID

    NCT02201004

    Start Date

    June 1 2014

    End Date

    October 1 2016

    Last Update

    October 11 2017

    Active Locations (30)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (30 locations)

    1

    Investigational Site Number 392-028

    Adachi-ku, Japan

    2

    Investigational Site Number 392-007

    Atsugi-shi, Japan

    3

    Investigational Site Number 392-026

    Chuoh-ku, Japan

    4

    Investigational Site Number 392-021

    Fukuoka, Japan