Phase 3
Completed N=507
Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
Source: ClinicalTrials.gov NCT03066830 ↗Enrolled (actual)
507
Serious AEs
14.2%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 — 0.06; -0.70 percentage HbA1c — p=< 0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Primary Objective:
To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin.
Secondary Objectives:
* 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 participants with baseline SBP ≥130 millimeter of mercury (mm Hg).
* Change from baseline in SBP for all participants.
* Change from baseline in body weight.
* Percentage of participants with HbA1c <6.5% and <7.0%.
* To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 |
0.06; -0.70 | < 0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
0.277; -1.331 | < 0.0001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg |
-3.58; -4.41 | 0.5172 |
| SECONDARY Change From Baseline in SBP at Week 12 for All Participants |
-0.69; -1.71 | 0.2994 |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
-0.29; -1.70 | < 0.0001 sig |
| SECONDARY Percentage of Participants With HbA1c <6.5% at Week 26 |
1.6; 8.3 | 0.0004 sig |
| SECONDARY Percentage of Participants With HbA1c <7.0% at Week 26 |
8.7; 26.1 | < 0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Participants 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 screening.
- Signed written informed consent.
Exclusion criteria
- At the time of screening, age 45 kilograms per meter square (kg/m^2) at Screening.
- Hemoglobin A1c (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 millimeter per mercury (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.
- Participants is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the participant's diary as required per protocol.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03066830). 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.