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TOFO Insulin Combination Trial

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ClinicalTrials.gov Identifier: NCT02201004
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
Kowa Company, Ltd.
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: TOFOGLIFLOZIN CSG452 Drug: insulin Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tofogliflozin
Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.
Drug: TOFOGLIFLOZIN CSG452
Pharmaceutical form:tablet Route of administration: oral
Other Names:
  • Apleway
  • Deberza

Drug: insulin
Pharmaceutical form:solution Route of administration: subcutaneous

Placebo Comparator: placebo
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
Pharmaceutical form:tablet Route of administration: oral
Other Names:
  • Apleway
  • Deberza

Drug: insulin
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: placebo
Pharmaceutical form:tablet Route of administration: oral




Primary Outcome Measures :
  1. Change in HbA1c from baseline [ Time Frame: 16 weeks after first intake of investigational product ]

Secondary Outcome Measures :
  1. Change of Body Weight (BW) from baseline [ Time Frame: 16 weeks after first intake of investigational product ]
  2. Change of FPG from baseline [ Time Frame: 16 weeks after first intake of investigational product ]
  3. Change of PPG from baseline [ Time Frame: 16 weeks after first intake of investigational product ]
  4. Number of subjects with adverse events [ Time Frame: Up to 52 weeks from the first intake of investigational medicinal product ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201004


Locations
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Japan
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-shi, 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-shi, 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-shi, Japan
Investigational Site Number 392-024
Kyoto-shi, Japan
Investigational Site Number 392-006
Matsudo-shi, Japan
Investigational Site Number 392-008
Mito-shi, Japan
Investigational Site Number 392-030
Musashino-shi, Japan
Investigational Site Number 392-029
Okayama-shi, Japan
Investigational Site Number 392-017
Otsu-shi, Japan
Investigational Site Number 392-011
Sagamihara-shi, Japan
Investigational Site Number 392-020
Sakai-shi, Japan
Investigational Site Number 392-010
Sapporo-shi, Japan
Investigational Site Number 392-016
Sendai-shi, Japan
Investigational Site Number 392-018
Shinjuku-ku, Japan
Investigational Site Number 392-005
Shizuoka-shi, 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-shi, Japan
Sponsors and Collaborators
Sanofi
Kowa Company, Ltd.
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications of Results:
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02201004     History of Changes
Other Study ID Numbers: TOFOGL07061
U1111-1159-5316 ( UTN )
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action