A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea alone or in combination with Metformin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or with Metformin

Sanofi-aventis Recherche & Développement0 sites625 target enrollmentMarch 21, 2017

Overview

No summary available.

Registry

who.int

Start Date

March 21, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\-Patients with T2D treated with a sulfonylurea (\=half the maximum recommended dose as per local label or maximum tolerated dose \[documented]) as monotherapy or in combination with metformin (\=1500 mg per day or maximum tolerated dose\[documented]) each at a stable dose for at least 12 weeks without a dose adjustment before enrollment.
•\-Signed written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 469
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 156

•\-At the time of screening age \<18 years.
•\-Hemoglobin A1c (HbA1c) \<7% or HbA1c \>10% via central lab test at screening.
•\-Fasting plasma glucose (FPG) \>15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1\), and confirmed (\>15 mmol/L \[270 mg/dL]) by a repeat test before randomization.
•\-Women of childbearing potential with no effective contraceptive method.
•\-Treated with an antidiabetic pharmacological regimen other than a sulfonylurea at a stable dose with or without metformin within 12 weeks preceding the screening visit.
•\-Previous insulin use \>1 month (at any time, aside from treatment of gestational diabetes).
•\-History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit.
•\-History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
•\-History of severe hypoglycemia within 6 months prior to the Screening visit.
•\-Systolic blood pressure (SBP) \>180 mmHg or diastolic blood pressure (DBP) \>100 mmHg or history of hypertensive emergency