Efficacy and Safety of Sotagliflozin versus Placebo in Patients with Type 2 Diabetes Mellitus on Background of Sulfonylurea alone or with Metformi
- Conditions
- Type 2 diabetes mellitusMedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-002826-35-PL
- Lead Sponsor
- Sanofi-aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 625
-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
-Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range (ULN)
-Total bilirubin: >1.5 times ULN (except in case of Gilbert’s syndrome).
-Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
-Pregnancy, breastfeeding.
-Patient is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the patient’s diary as required per protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the superiority of sotagliflozin 400 mg versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in patients with type 2 diabetes (T2D) who have inadequate glycemic control with a sulfonylurea alone or in combination with metformin;<br> Secondary Objective: -To compare sotagliflozin 400 mg versus placebo based on:<br> -Change from baseline in fasting plasma glucose (FPG).<br> -Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP =130 mm Hg.<br> -Change from baseline in SBP for all patients.<br> -Change from baseline in body weight.<br> -Proportion of patients with HbA1c <6.5% and <7.0%.<br> -To evaluate the safety of sotagliflozin 400 mg versus placebo throughout the 79 -week trial.<br> ;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: Baseline to Week 26
- Secondary Outcome Measures
Name Time Method