TOFO Insulin Combination Trial

NCT ID: NCT02201004

Last Updated: 2017-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-10-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tofogliflozin

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

Group Type: EXPERIMENTAL

TOFOGLIFLOZIN CSG452

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

insulin

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

placebo

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

Group Type: PLACEBO_COMPARATOR

TOFOGLIFLOZIN CSG452

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

insulin

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

placebo

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Interventions

TOFOGLIFLOZIN CSG452

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

insulin

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type: DRUG

placebo

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

Other Intervention Names

Apleway; Deberza

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kowa Company, Ltd.

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392-028

Adachi-ku, , Japan

Investigational Site Number 392-007

Atsugi-shi, , Japan

Investigational Site Number 392-026

Chuoh-ku, , Japan

Investigational Site Number 392-021

Fukuoka, , Japan

Investigational Site Number 392-002

Ichihara-shi, , Japan

Investigational Site Number 392-012

Iruma-shi, , Japan

Investigational Site Number 392-003

Kawaguchi-shi, , Japan

Investigational Site Number 392-014

Kitakyusyu-shi, , Japan

Investigational Site Number 392-027

Kobe, , Japan

Investigational Site Number 392-004

Koga-shi, , Japan

Investigational Site Number 392-022

Kunitachi-shi, , Japan

Investigational Site Number 392-019

Kurume-shi, , Japan

Investigational Site Number 392-001

Kyoto, , Japan

Investigational Site Number 392-024

Kyoto, , Japan

Investigational Site Number 392-006

Matsudo-shi, , Japan

Investigational Site Number 392-008

Mito, , Japan

Investigational Site Number 392-030

Musashino-shi, , Japan

Investigational Site Number 392-029

Okayama, , Japan

Investigational Site Number 392-017

Ōtsu, , Japan

Investigational Site Number 392-011

Sagamihara-shi, , Japan

Investigational Site Number 392-020

Sakaishi, , Japan

Investigational Site Number 392-010

Sapporo, , Japan

Investigational Site Number 392-016

Sendai, , Japan

Investigational Site Number 392-018

Shinjuku-ku, , Japan

Investigational Site Number 392-005

Shizuoka, , Japan

Investigational Site Number 392-031

Suita-shi, , Japan

Investigational Site Number 392-015

Sumida-ku, , Japan

Investigational Site Number 392-023

Sunto-gun, , Japan

Investigational Site Number 392-013

Tokorozawa-shi, , Japan

Investigational Site Number 392-025

Yokohama, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 28371205 (View on PubMed)

Other Identifiers

U1111-1159-5316

Identifier Type: -

Identifier Source: secondary_id

TOFOGL07061

Identifier Type: -

Identifier Source: org_study_id