Phase 2
Completed N=87
Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
Source: ClinicalTrials.gov NCT02383940 ↗Enrolled (actual)
87
Serious AEs
5.9%
Results posted
Oct 2019
Primary outcomePrimary: Change From Baseline in Hemoglobin A1C (A1C) at Week 12 — -0.99; -1.33 percentage of A1C — p=0.10
Summary
This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1C (A1C) at Week 12 |
-0.99; -1.33 | 0.10 |
| SECONDARY Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12 |
-2.96; -4.89; 3.26; 2.03 | — |
| SECONDARY Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12 |
0.2; -56.4 | — |
| SECONDARY Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12 |
-5.035; -27.338; 0.221; 0.428 | — |
| SECONDARY Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12 |
-0.042; -0.001 | — |
Eligibility Criteria
Inclusion Criteria
- Participant had given written informed consent.
- Young adult participants >=18 to = 9.0%.
- Must be willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary.
- Females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test.
Exclusion Criteria
- Any prior use of LX4211/sotagliflozin.
- Use of antidiabetic agent other than insulin or insulin analogue at the time of screening.
- Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of the placebo Run-in Period.
- Chronic systemic corticosteroid use.
- Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the Investigator.
- History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6 months prior to the Screening Visit.
- History of severe hypoglycemic event within 1 month prior to the Screening Visit.
Data sourced from ClinicalTrials.gov (NCT02383940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.