TOFO Insulin Combination Trial

NCT02201004 | Completed Phase 4

• 2 other identifiers: TOFOGL07061U1111-1159-5316
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 30

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline

  16 weeks after first intake of investigational product

Secondary Outcomes (4)

• Change of Body Weight (BW) from baseline

  16 weeks after first intake of investigational product

• Change of FPG from baseline

  16 weeks after first intake of investigational product

• Change of PPG from baseline

  16 weeks after first intake of investigational product

• Number of subjects with adverse events

  Up to 52 weeks from the first intake of investigational medicinal product

Study Arms (2)

tofogliflozin

EXPERIMENTAL

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

Drug: TOFOGLIFLOZIN CSG452; Drug: insulin

placebo

PLACEBO COMPARATOR

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

Drug: TOFOGLIFLOZIN CSG452; Drug: insulin; Drug: placebo

Interventions

TOFOGLIFLOZIN CSG452 DRUG

Pharmaceutical form:tablet Route of administration: oral

Also known as: Apleway, Deberza

placebo; tofogliflozin

insulin DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

placebo; tofogliflozin

placebo DRUG

Pharmaceutical form:tablet Route of administration: oral

placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead
• Kowa Company, Ltd.: collaborator

Study Sites (30)

Investigational Site Number 392-028

Adachi-ku, Japan

Location

Investigational Site Number 392-007

Atsugi-shi, Japan

Location

Investigational Site Number 392-026

Chuoh-ku, Japan

Location

Investigational Site Number 392-021

Fukuoka, Japan

Location

Investigational Site Number 392-002

Ichihara-shi, Japan

Location

Investigational Site Number 392-012

Iruma-shi, Japan

Location

Investigational Site Number 392-003

Kawaguchi-shi, Japan

Location

Investigational Site Number 392-014

Kitakyusyu-shi, Japan

Location

Investigational Site Number 392-027

Kobe, Japan

Location

Investigational Site Number 392-004

Koga-shi, Japan

Location

Investigational Site Number 392-022

Kunitachi-shi, Japan

Location

Investigational Site Number 392-019

Kurume-shi, Japan

Location

Investigational Site Number 392-001

Kyoto, Japan

Location

Investigational Site Number 392-024

Kyoto, Japan

Location

Investigational Site Number 392-006

Matsudo-shi, Japan

Location

Investigational Site Number 392-008

Mito, Japan

Location

Investigational Site Number 392-030

Musashino-shi, Japan

Location

Investigational Site Number 392-029

Okayama, Japan

Location

Investigational Site Number 392-017

Ōtsu, Japan

Location

Investigational Site Number 392-011

Sagamihara-shi, Japan

Location

Investigational Site Number 392-020

Sakaishi, Japan

Location

Investigational Site Number 392-010

Sapporo, Japan

Location

Investigational Site Number 392-016

Sendai, Japan

Location

Investigational Site Number 392-018

Shinjuku-ku, Japan

Location

Investigational Site Number 392-005

Shizuoka, Japan

Location

Investigational Site Number 392-031

Suita-shi, Japan

Location

Investigational Site Number 392-015

Sumida-ku, Japan

Location

Investigational Site Number 392-023

Sunto-gun, Japan

Location

Investigational Site Number 392-013

Tokorozawa-shi, Japan

Location

Investigational Site Number 392-025

Yokohama, Japan

Location

Related Publications (1)

• 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.

  PMID: 28371205 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

JP (30)