Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03066830
• Date of registration: 24/02/2017
• Prospective Registration: Yes
• Primary sponsor: Lexicon Pharmaceuticals
• Public title: Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea Alone or in Combination With Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or With Metformin
• Date of first enrolment: February 24, 2017
• Target sample size: 507
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03066830
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Estonia, Hungary, Korea, Republic of, Poland, Romania, Slovakia, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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
screening.

- Signed written informed consent.

Exclusion criteria:

- At the time of screening, age <18 years or < legal age of majority, whichever is
greater.

- Body Mass Index (BMI) =20 or >45 kg/m² at Screening

- 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.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Sotagliflozin (SAR439954)

Drug: placebo

Drug: Sulfonylurea

Drug: Metformin

Primary Outcome(s)

Change from baseline in HbA1c [Time Frame: Baseline to Week 26]

Secondary Outcome(s)

Change from baseline in Systolic Blood Pressure (SBP) for patients with baseline SBP =130 mmHg [Time Frame: Baseline to Week 12]

Change from baseline in SBP for all patients [Time Frame: Baseline to Week 12]

Percentage of patients with HbA1c <7.0% [Time Frame: At Week 26]

Change from baseline in body weight [Time Frame: Baseline to Week 26]

Change from baseline in Fasting Plasma Glucose [Time Frame: Baseline to Week 26]

Percentage of patients with HbA1c <6.5% [Time Frame: At Week 26]

Secondary ID(s)

2016-002826-35

U1111-1186-2612

EFC14835

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi