Type 1 Diabetes Mellitus MedDRA version: 19.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Sotagliflozin
Product Code: LX4211
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Sotagliflozin
CAS Number: 1018899-04-1
Current Sponsor code: LX4211
Other descriptive name: LX-
Sponsors
Lexicon Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient has given written informed consent to participate in the study in accordance with local regulations 2) Adult patients 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent 3) Patients are being treated with insulin(s) or insulin analog(s) 4) Non-fast acting insulin dose is stable (±20%) for 2 weeks prior to the Screening Visit 5) At the Screening Visit, A1C must be between 7.0% and 11.0%, inclusive 6) BMI =18.5 kg/m2 7) Must be willing and able to perform SMBG and complete the study diary as required per protocol 8) Females of childbearing potential must use an adequate method of contraception to avoid pregnancy throughout the duration of the study and for 30 days after the last dose of study drug. Females of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Postmenopause is defined as no menses for =12 months without another cause. For females with questionable menopausal history (eg, irregular menstrual periods and age >40 years) a documented serum follicle-stimulating hormone (FSH) level must be =30 mIU/mL. 9) Females of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug. In the case of positive urine pregnancy testing, a negative serum sample for pregnancy testing, to confirm that the patient is not pregnant, must be obtained prior to start of study. 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 1050 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 1) Therapies and/or medications: a) Use of antidiabetic agent other than insulin(s) or insulin analog(s) at the time of screening (any medication other than insulin or insulin analog used for treatment of T1D must be washed out for at least 8 weeks prior to the Screening Visit) b) Any prior exposure to sotagliflozin c) Use of SGLT inhibitors within 8 weeks prior to Screening. d) Chronic systemic corticosteroid use, defined as any dose of systemic corticosteroid taken for more than 4 consecutive weeks within the 6 months prior to the Screening Visit. 2) Diabetes-related conditions: a) Type 2 diabetes mellitus, or severely uncontrolled T1D as determined by the Investigator b) History of severe hypoglycemic event within 1 month prior to the Screening Visitc) History of DKA or nonketotic hyperosmolar state within 1 month of Screening OR =2 episodes of DKA or nonketotic hyperosmolar state within 6 months of Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of sotagliflozin 400 mg versus placebo in the proportion of patients with glycosylated A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis (DKA) after randomization.;Secondary Objective: To evaluate the change from Baseline of sotagliflozin versus placebo in hierarchical order on the following: • A1C • Body weight • Systolic blood pressure (SBP) • Bolus insulin dose;Primary end point(s): 1) To demonstrate the superiority of sotagliflozin 400 mg versus placebo in the proportion of patients with A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of DKA after randomization when used as an adjunct in normal weight and overweight/obese adult patients with T1D who have inadequate glycemic control with insulin therapy.;Timepoint(s) of evaluation of this end point: 1) At Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To be measured as change from Baseline in sotagliflozin 400 mg compared to placebo for each of the following: 2) A1C at Week 24 3) Body weight at Week 24 (absolute and percent change) 4) SBP at Week 16 in the subset of patients with Baseline SBP =130 mm Hg 5) Bolus insulin dose at Week 24 (as an average over the 3-5 days prior to the visit);Timepoint(s) of evaluation of this end point: 2) At week 24 3) At week 24 4) At week 16 5) At week 24 | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, France, Germany, Hungary, Israel, Italy, New Zealand, Peru, Poland, Slovakia, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactSenior Medical Director
Lexicon Pharmaceuticals, Inc.
Outcome results
None listed