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TOFO Insulin Combination Trial

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
TOFOGLIFLOZIN CSG452
insulin
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 392-028
  • Investigational Site Number 392-007
  • Investigational Site Number 392-026
  • Investigational Site Number 392-021
  • Investigational Site Number 392-002
  • Investigational Site Number 392-012
  • Investigational Site Number 392-003
  • Investigational Site Number 392-014
  • Investigational Site Number 392-027
  • Investigational Site Number 392-004
  • Investigational Site Number 392-022
  • Investigational Site Number 392-019
  • Investigational Site Number 392-001
  • Investigational Site Number 392-024
  • Investigational Site Number 392-006
  • Investigational Site Number 392-008
  • Investigational Site Number 392-030
  • Investigational Site Number 392-029
  • Investigational Site Number 392-017
  • Investigational Site Number 392-011
  • Investigational Site Number 392-020
  • Investigational Site Number 392-010
  • Investigational Site Number 392-016
  • Investigational Site Number 392-018
  • Investigational Site Number 392-005
  • Investigational Site Number 392-031
  • Investigational Site Number 392-015
  • Investigational Site Number 392-023
  • Investigational Site Number 392-013
  • Investigational Site Number 392-025

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tofogliflozin

placebo

Arm Description

Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.

Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline

Secondary Outcome Measures

Change of Body Weight (BW) from baseline
Change of FPG from baseline
Change of PPG from baseline
Number of subjects with adverse events

Full Information

First Posted
July 23, 2014
Last Updated
October 10, 2017
Sponsor
Sanofi
Collaborators
Kowa Company, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02201004
Brief Title
TOFO Insulin Combination Trial
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Kowa Company, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tofogliflozin
Arm Type
Experimental
Arm Description
Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.
Intervention Type
Drug
Intervention Name(s)
TOFOGLIFLOZIN CSG452
Other Intervention Name(s)
Apleway, Deberza
Intervention Description
Pharmaceutical form:tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
insulin
Intervention Description
Pharmaceutical form:solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Pharmaceutical form:tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline
Time Frame
16 weeks after first intake of investigational product
Secondary Outcome Measure Information:
Title
Change of Body Weight (BW) from baseline
Time Frame
16 weeks after first intake of investigational product
Title
Change of FPG from baseline
Time Frame
16 weeks after first intake of investigational product
Title
Change of PPG from baseline
Time Frame
16 weeks after first intake of investigational product
Title
Number of subjects with adverse events
Time Frame
Up to 52 weeks from the first intake of investigational medicinal product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 392-028
City
Adachi-ku
Country
Japan
Facility Name
Investigational Site Number 392-007
City
Atsugi-shi
Country
Japan
Facility Name
Investigational Site Number 392-026
City
Chuoh-ku
Country
Japan
Facility Name
Investigational Site Number 392-021
City
Fukuoka-shi
Country
Japan
Facility Name
Investigational Site Number 392-002
City
Ichihara-shi
Country
Japan
Facility Name
Investigational Site Number 392-012
City
Iruma-shi
Country
Japan
Facility Name
Investigational Site Number 392-003
City
Kawaguchi-shi
Country
Japan
Facility Name
Investigational Site Number 392-014
City
Kitakyusyu-shi
Country
Japan
Facility Name
Investigational Site Number 392-027
City
Kobe-shi
Country
Japan
Facility Name
Investigational Site Number 392-004
City
Koga-shi
Country
Japan
Facility Name
Investigational Site Number 392-022
City
Kunitachi-shi
Country
Japan
Facility Name
Investigational Site Number 392-019
City
Kurume-shi
Country
Japan
Facility Name
Investigational Site Number 392-001
City
Kyoto-shi
Country
Japan
Facility Name
Investigational Site Number 392-024
City
Kyoto-shi
Country
Japan
Facility Name
Investigational Site Number 392-006
City
Matsudo-shi
Country
Japan
Facility Name
Investigational Site Number 392-008
City
Mito-shi
Country
Japan
Facility Name
Investigational Site Number 392-030
City
Musashino-shi
Country
Japan
Facility Name
Investigational Site Number 392-029
City
Okayama-shi
Country
Japan
Facility Name
Investigational Site Number 392-017
City
Otsu-shi
Country
Japan
Facility Name
Investigational Site Number 392-011
City
Sagamihara-shi
Country
Japan
Facility Name
Investigational Site Number 392-020
City
Sakai-shi
Country
Japan
Facility Name
Investigational Site Number 392-010
City
Sapporo-shi
Country
Japan
Facility Name
Investigational Site Number 392-016
City
Sendai-shi
Country
Japan
Facility Name
Investigational Site Number 392-018
City
Shinjuku-ku
Country
Japan
Facility Name
Investigational Site Number 392-005
City
Shizuoka-shi
Country
Japan
Facility Name
Investigational Site Number 392-031
City
Suita-shi
Country
Japan
Facility Name
Investigational Site Number 392-015
City
Sumida-ku
Country
Japan
Facility Name
Investigational Site Number 392-023
City
Sunto-gun
Country
Japan
Facility Name
Investigational Site Number 392-013
City
Tokorozawa-shi
Country
Japan
Facility Name
Investigational Site Number 392-025
City
Yokohama-shi
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28371205
Citation
Terauchi Y, Tamura M, Senda M, Gunji R, Kaku K. Efficacy and safety of tofogliflozin in Japanese patients with type 2 diabetes mellitus with inadequate glycaemic control on insulin therapy (J-STEP/INS): Results of a 16-week randomized, double-blind, placebo-controlled multicentre trial. Diabetes Obes Metab. 2017 Oct;19(10):1397-1407. doi: 10.1111/dom.12957. Epub 2017 Jul 13.
Results Reference
result

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TOFO Insulin Combination Trial

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