- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02201004
TOFO Insulin Combination Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Adachi-ku, Japan
- Investigational Site Number 392-028
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Atsugi-shi, Japan
- Investigational Site Number 392-007
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Chuoh-ku, Japan
- Investigational Site Number 392-026
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Fukuoka-shi, Japan
- Investigational Site Number 392-021
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Ichihara-shi, Japan
- Investigational Site Number 392-002
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Iruma-shi, Japan
- Investigational Site Number 392-012
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Kawaguchi-shi, Japan
- Investigational Site Number 392-003
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Kitakyusyu-shi, Japan
- Investigational Site Number 392-014
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Kobe-shi, Japan
- Investigational Site Number 392-027
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Koga-shi, Japan
- Investigational Site Number 392-004
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Kunitachi-shi, Japan
- Investigational Site Number 392-022
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Kurume-shi, Japan
- Investigational Site Number 392-019
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Kyoto-shi, Japan
- Investigational Site Number 392-001
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Kyoto-shi, Japan
- Investigational Site Number 392-024
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Matsudo-shi, Japan
- Investigational Site Number 392-006
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Mito-shi, Japan
- Investigational Site Number 392-008
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Musashino-shi, Japan
- Investigational Site Number 392-030
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Okayama-shi, Japan
- Investigational Site Number 392-029
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Otsu-shi, Japan
- Investigational Site Number 392-017
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Sagamihara-shi, Japan
- Investigational Site Number 392-011
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Sakai-shi, Japan
- Investigational Site Number 392-020
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Sapporo-shi, Japan
- Investigational Site Number 392-010
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Sendai-shi, Japan
- Investigational Site Number 392-016
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Shinjuku-ku, Japan
- Investigational Site Number 392-018
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Shizuoka-shi, Japan
- Investigational Site Number 392-005
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Suita-shi, Japan
- Investigational Site Number 392-031
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Sumida-ku, Japan
- Investigational Site Number 392-015
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Sunto-gun, Japan
- Investigational Site Number 392-023
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Tokorozawa-shi, Japan
- Investigational Site Number 392-013
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Yokohama-shi, Japan
- Investigational Site Number 392-025
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tofogliflozin
Tofogliflozin administered once daily for 52 weeks.
Insulin administered as base treatment.
|
Pharmaceutical form:tablet Route of administration: oral
Other Names:
Pharmaceutical form:solution Route of administration: subcutaneous
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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.
|
Pharmaceutical form:tablet Route of administration: oral
Other Names:
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HbA1c from baseline
Time Frame: 16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of Body Weight (BW) from baseline
Time Frame: 16 weeks after first intake of investigational product
|
16 weeks after first intake of investigational product
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Change of FPG from baseline
Time Frame: 16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
|
Change of PPG from baseline
Time Frame: 16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Number of subjects with adverse events
Time Frame: Up to 52 weeks from the first intake of investigational medicinal product
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Up to 52 weeks from the first intake of investigational medicinal product
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
Other Study ID Numbers
- TOFOGL07061
- U1111-1159-5316 (UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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