Type 2 Diabetes Mellitus
Conditions
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.
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.
Interventions
DRUGTOFOGLIFLOZIN CSG452
Pharmaceutical form:tablet Route of administration: oral
DRUGinsulin
Pharmaceutical form:solution Route of administration: subcutaneous
DRUGplacebo
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Kowa Company, Ltd.
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline | 16 weeks after first intake of investigational product |
Secondary
| Measure | Time frame |
|---|---|
| Change of Body Weight (BW) from baseline | 16 weeks after first intake of investigational product |
| Change of FPG from baseline | 16 weeks after first intake of investigational product |
| Change of PPG from baseline | 16 weeks after first intake of investigational product |
| Number of subjects with adverse events | Up to 52 weeks from the first intake of investigational medicinal product |
Countries
Japan
Outcome results
None listed