Type 2 diabetes mellitus MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Sotagliflozin
Product Code: SAR439954
Pharmaceutical Form: Tablet
INN or Proposed INN: SOTAGLIFLOZIN
Current Sponsor code:
Sponsors
Lexicon Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -At the time of screening age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: Baseline to Week 26;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; Secondary Objective: -To compare sotagliflozin 400 mg versus placebo based on: -Change from baseline in fasting plasma glucose (FPG). -Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP =130 mm Hg. -Change from baseline in SBP for all patients. -Change from baseline in body weight. -Proportion of patients with HbA1c <6.5% and <7.0%. -To evaluate the safety of sotagliflozin 400 mg versus placebo throughout the 79 -week trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Change from baseline in FPG 2- Change from baseline in SBP for patients with baseline SBP =130 mmHg 3- Change from baseline in SBP for all patients 4- Change from baseline in body weight 5- Percentage of patients with HbA1c <6.5% 6- Percentage of patients with HbA1c <7.0% 7- Measurement of bone metabolism markers 8- Measurement of calcium metabolism markers 9- Measurement of intestinal transit markers 10- Measurement of intestinal absorption markers ; Timepoint(s) of evaluation of this end point: 1- Change from baseline in FPG : Baseline to Week 26 2- Change from baseline in SBP for patients with baseline SBP =130 mmHg : Baseline to Week 12 3- Change from baseline in SBP for all patients : Baseline to Week 12 4- Change from baseline in body weight : Baseline to Week 26 5- Percentage of patients with HbA1c <6.5% : At Week 26 6- Percentage of patients with HbA1c <7.0% : At Week 26 7- Measurement of bone metabolism markers : Baseline to Week 79 8- Measurement of calcium metabolism markers : Baseline to Week 79 9- Measurement of intestinal transit markers : Baseline to Week 79 10- Measurement of intestinal absorption markers : Baseline to Week 79 | — |
Countries
Bulgaria, Estonia, Hungary, Korea, Republic of, Poland, Romania, Slovakia, Ukraine, United Kingdom, United States
Contacts
Public ContactExecutive Director, Clinical Ops
Lexicon Pharmaceuticals, Inc.
Outcome results
None listed