TOFO Insulin Combination Trial

October 10, 2017 updated by: Sanofi

A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus

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 over a period of 16 weeks in patients with type 2 diabetes mellitus.

To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.

Secondary Objectives:

To assess the effects of tofogliflozin in comparison to placebo on:

  • Body weight
  • Fasting plasma glucose (FPG)
  • Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.

Study Overview

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 open-labeled extension period of 36 weeks, and a follow-up period of 3 days.

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Adachi-ku, Japan
        • Investigational Site Number 392-028
      • Atsugi-shi, Japan
        • Investigational Site Number 392-007
      • Chuoh-ku, Japan
        • Investigational Site Number 392-026
      • Fukuoka-shi, Japan
        • Investigational Site Number 392-021
      • Ichihara-shi, Japan
        • Investigational Site Number 392-002
      • Iruma-shi, Japan
        • Investigational Site Number 392-012
      • Kawaguchi-shi, Japan
        • Investigational Site Number 392-003
      • Kitakyusyu-shi, Japan
        • Investigational Site Number 392-014
      • Kobe-shi, Japan
        • Investigational Site Number 392-027
      • Koga-shi, Japan
        • Investigational Site Number 392-004
      • Kunitachi-shi, Japan
        • Investigational Site Number 392-022
      • Kurume-shi, Japan
        • Investigational Site Number 392-019
      • Kyoto-shi, Japan
        • Investigational Site Number 392-001
      • Kyoto-shi, Japan
        • Investigational Site Number 392-024
      • Matsudo-shi, Japan
        • Investigational Site Number 392-006
      • Mito-shi, Japan
        • Investigational Site Number 392-008
      • Musashino-shi, Japan
        • Investigational Site Number 392-030
      • Okayama-shi, Japan
        • Investigational Site Number 392-029
      • Otsu-shi, Japan
        • Investigational Site Number 392-017
      • Sagamihara-shi, Japan
        • Investigational Site Number 392-011
      • Sakai-shi, Japan
        • Investigational Site Number 392-020
      • Sapporo-shi, Japan
        • Investigational Site Number 392-010
      • Sendai-shi, Japan
        • Investigational Site Number 392-016
      • Shinjuku-ku, Japan
        • Investigational Site Number 392-018
      • Shizuoka-shi, Japan
        • Investigational Site Number 392-005
      • Suita-shi, Japan
        • Investigational Site Number 392-031
      • Sumida-ku, Japan
        • Investigational Site Number 392-015
      • Sunto-gun, Japan
        • Investigational Site Number 392-023
      • Tokorozawa-shi, Japan
        • Investigational Site Number 392-013
      • Yokohama-shi, Japan
        • Investigational Site Number 392-025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tofogliflozin
Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.
Pharmaceutical form:tablet Route of administration: oral
Other Names:
  • Apleway
  • Deberza
Pharmaceutical form:solution Route of administration: subcutaneous
Placebo Comparator: placebo
Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.
Pharmaceutical form:tablet Route of administration: oral
Other Names:
  • Apleway
  • Deberza
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c from baseline
Time Frame: 16 weeks after first intake of investigational product
16 weeks after first intake of investigational product

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Body Weight (BW) from baseline
Time Frame: 16 weeks after first intake of investigational product
16 weeks after first intake of investigational product
Change of FPG from baseline
Time Frame: 16 weeks after first intake of investigational product
16 weeks after first intake of investigational product
Change of PPG from baseline
Time Frame: 16 weeks after first intake of investigational product
16 weeks after first intake of investigational product
Number of subjects with adverse events
Time Frame: Up to 52 weeks from the first intake of investigational medicinal product
Up to 52 weeks from the first intake of investigational medicinal product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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