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Type 2 Diabetes MellitusPhase 4NCT02201004

TOFO Insulin Combination Trial

A Phase 4 study testing TOFOGLIFLOZIN CSG452 and insulin in people with Type 2 Diabetes Mellitus, run by Sanofi at 30 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
TOFOGLIFLOZIN CSG452 and insulin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
211 participants
Where
30 sitesJapan
Study dates
Jun 2014to Oct 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Japan30 sites

  • Investigational Site Number 392-028

    Adachi-ku

  • Investigational Site Number 392-007

    Atsugi-shi

  • Investigational Site Number 392-026

    Chuoh-ku

  • Investigational Site Number 392-021

    Fukuoka

  • Investigational Site Number 392-002

    Ichihara-shi

  • Investigational Site Number 392-012

    Iruma-shi

  • Investigational Site Number 392-003

    Kawaguchi-shi

  • Investigational Site Number 392-014

    Kitakyusyu-shi

  • Investigational Site Number 392-027

    Kobe

  • Investigational Site Number 392-004

    Koga-shi

  • Investigational Site Number 392-022

    Kunitachi-shi

  • Investigational Site Number 392-019

    Kurume-shi

  • Investigational Site Number 392-001

    Kyoto

  • Investigational Site Number 392-024

    Kyoto

  • Investigational Site Number 392-006

    Matsudo-shi

  • Investigational Site Number 392-008

    Mito

  • Investigational Site Number 392-030

    Musashino-shi

  • Investigational Site Number 392-029

    Okayama

  • Investigational Site Number 392-017

    Ōtsu

  • Investigational Site Number 392-011

    Sagamihara-shi

  • Investigational Site Number 392-020

    Sakaishi

  • Investigational Site Number 392-010

    Sapporo

  • Investigational Site Number 392-016

    Sendai

  • Investigational Site Number 392-018

    Shinjuku-ku

  • Investigational Site Number 392-005

    Shizuoka

  • Investigational Site Number 392-031

    Suita-shi

  • Investigational Site Number 392-015

    Sumida-ku

  • Investigational Site Number 392-023

    Sunto-gun

  • Investigational Site Number 392-013

    Tokorozawa-shi

  • Investigational Site Number 392-025

    Yokohama

Other trials in Japan

About this study

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

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.
Read the 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.

Being tested
TOFOGLIFLOZIN CSG452, insulin, placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOFOGLIFLOZIN CSG452Drug

    Also called Apleway, Deberza

    Pharmaceutical form:tablet Route of administration: oral

  • insulinDrug

    Pharmaceutical form:solution Route of administration: subcutaneous

  • placeboDrug

    Pharmaceutical form:tablet Route of administration: oral

Study groups in NCT02201004
Study groupRoleWhat they receive
tofogliflozinExperimentalTofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.
Receives: Drug: TOFOGLIFLOZIN CSG452; Drug: insulin
placeboPlacebo comparatorPlacebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.
Receives: Drug: TOFOGLIFLOZIN CSG452; Drug: insulin; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c from baseline

    Measured: 16 weeks after first intake of investigational product

Secondary outcomes (4)

  1. Change of Body Weight (BW) from baseline

    Measured: 16 weeks after first intake of investigational product

  2. Change of FPG from baseline

    Measured: 16 weeks after first intake of investigational product

  3. Change of PPG from baseline

    Measured: 16 weeks after first intake of investigational product

  4. Number of subjects with adverse events

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJan 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02201004
Sponsor's protocol ID
TOFOGL07061
Other IDs
U1111-1159-5316
Status last verified
Oct 2017
First submitted
23 Jul 2014
Last updated
11 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28371205

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TOFOGLIFLOZIN CSG452 and insulin in people with Type 2 Diabetes Mellitus, run by Sanofi at 30 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c from baseline (time frame: 16 weeks after first intake of investigational product). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02201004, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.

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