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TOFO Insulin Combination Trial

NCT02201004 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2017-10-11

No results posted yet for this study

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

Interventions

DRUG

TOFOGLIFLOZIN CSG452

Pharmaceutical form:tablet Route of administration: oral

DRUG

insulin

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

placebo

Pharmaceutical form:tablet Route of administration: oral

Sponsors & Collaborators

  • Kowa Company, Ltd.

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-01-31
Completion
2016-10-31

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02201004 on ClinicalTrials.gov