NCT02201004 is a Phase 4 clinical trial of TOFOGLIFLOZIN CSG452 in Type 2 Diabetes Mellitus, sponsored by Sanofi.

Who is sponsoring NCT02201004?

NCT02201004 is sponsored by Sanofi.

What drugs are being tested in NCT02201004?

Interventions in NCT02201004: TOFOGLIFLOZIN CSG452, insulin, placebo.

What condition does NCT02201004 study?

NCT02201004 studies Type 2 Diabetes Mellitus.

Is NCT02201004 still recruiting?

NCT02201004 is currently completed. Last updated 10 October 2017.

Last reviewed 2017-10-10 · How we verify

NCT02201004

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 10 October 2017

What this trial tests

Phase 4 trial testing TOFOGLIFLOZIN CSG452 in Type 2 Diabetes Mellitus in 211 participants. Completed in 1 October 2016.

Timeline

1 June 2014

Primary endpoint
1 January 2016

1 October 2016

Quick facts

Lead sponsor	Sanofi
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	211
Start date	1 June 2014
Primary completion	1 January 2016
Estimated completion	1 October 2016
Sites	30 locations across Japan

Drugs / interventions tested

TOFOGLIFLOZIN CSG452 — full drug profile →
insulin (insulin) — full drug profile →
placebo

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Sanofi — full company profile →

Who can join

Adults 20 to 75, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in HbA1c from baseline
Time frame: 16 weeks after first intake of investigational product

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

SLC transporters as therapeutic targets: emerging opportunities.
Lin L, Yee SW, Kim RB, Giacomini KM. · · 2015 · cited 653× · PMID 26111766 · DOI 10.1038/nrd4626
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.
Terauchi Y, Tamura M, Senda M, Gunji R, et al · · 2017 · cited 36× · PMID 28371205 · DOI 10.1111/dom.12957
Long-term safety and efficacy of tofogliflozin as add-on to insulin in patients with type 2 diabetes: Results from a 52-week, multicentre, randomized, double-blind, open-label extension, Phase 4 study in Japan (J-STEP/INS).
Terauchi Y, Tamura M, Senda M, Gunji R, et al · · 2018 · cited 25× · PMID 29316236 · DOI 10.1111/dom.13213
Risk of diabetic ketoacidosis of SGLT2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials.
Yang S, Liu Y, Zhang S, Wu F, et al · · 2023 · cited 20× · PMID 37397500 · DOI 10.3389/fphar.2023.1145587
Risk of hypovolemia associated with sodium-glucose cotransporter-2 inhibitors treatment: A meta-analysis of randomized controlled trials.
Rong X, Zhu Y, Wen B, Liu K, et al · · 2022 · cited 14× · PMID 36451919 · DOI 10.3389/fcvm.2022.973129
Effects of sodium-glucose cotransporter-2 (SGLT-2) inhibitors on serum uric acid levels in patients with chronic kidney disease: a systematic review and network meta-analysis.
Zhang L, Zhang F, Bai Y, Huang L, et al · · 2024 · cited 10× · PMID 38238025 · DOI 10.1136/bmjdrc-2023-003836
Serum uric acid reduction through SGLT2 inhibitors: evidence from a systematic review and meta-analysis.
Yang S, Hu Q, Liu K, Xiao B, et al · · 2025 · cited 3× · PMID 40612743 · DOI 10.3389/fphar.2025.1551390
Sodium-glucose Cotransporter 2 Inhibitors' Rise to the Backbone of Heart Failure Management: A Clinical Review.
Rohant N, Kennedy JL. · · 2021 · PMID 36277321 · DOI 10.17925/hi.2021.15.1.42

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02201004 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 10 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02201004.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing