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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02926950
• Date of registration: 05/10/2016
• 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 Metformin
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
• Date of first enrolment: November 2016
• Target sample size: 518
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02926950
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Canada, Hungary, Slovakia, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria :

- Patients with Type 2 Diabetes currently treated with diet and exercise and on
metformin at a stable dose =1500 mg/day for at least 12 weeks. However, patients on
metformin at a dose <1500 mg/day at the time of enrollment (stable dose for at least
12 weeks before enrollment) may be eligible for screening if documentation of lack of
tolerance of a metformin dose =1500 mg/day can be provided.

- Signed written informed consent.

Exclusion criteria:

- Age <18 years at Screening or < legal age of majority, whichever is greater.

- Type 1 diabetes mellitus.

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

- Hemoglobin A1c <7% or >10% via central laboratory test at screening.

- Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory
at screening (Visit 1) and confirmed by a repeat test (>15 mmol/L [270 mg/dL]) before
randomization.

- Women of childbearing potential not willing to use highly effective method(s) of birth
control or who are unwilling or unable to be tested for pregnancy during the study.

- Treated with an antidiabetic pharmacological regimen other than metformin =1500 mg per
day (or maximum tolerated dose) within the 12 weeks preceding the Screening Visit.

- Previous use of any types of insulin for >1 month (at any time, aside from pregnancy
for treatment of gestational diabetes).

- History of prior gastric surgical procedure, including gastric banding, within 3 years
before the Screening Visit.

- History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior
to the Screening Visit.

- Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (diastolic
blood pressure [DBP]).

- History of hypertensive urgency or emergency within 12 weeks prior to Screening.

- Patients with severe anemia, severe cardiovascular (including congestive heart failure
New York Heart Association [NYHA] IV), respiratory, hepatic, neurological,
psychiatric, or active malignant tumor or other major systemic disease or patients
with short life expectancy making implementation of the protocol or interpretation of
the study results difficult.

- Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit
of the normal laboratory range.

- Total bilirubin: >1.5 times the upper limit of the normal laboratory range (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.

- Patient who has taken other investigational drugs or prohibited therapy for this study
within 12 weeks or 5 half-lives from screening or randomization, whichever is longer.

- Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.

- Patient is unwilling or unable to perform self-monitoring of blood glucose (SMBG),
complete the patient diary, or comply with study visits and other study procedures as
required per protocol.

- Contraindication to metformin as per local labeling.

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: Metformin

Drug: Placebo

Drug: Sotagliflozin (SAR439954)

Primary Outcome(s)

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

Secondary Outcome(s)

- Change from Baseline in SBP for all patients - Time Frame: Baseline to Week 12 - Safety issue: No [Time Frame: Baseline to Week 12]

- Change from Baseline in body weight - Time Frame: Baseline to Week 26 - Safety issue: No [Time Frame: Baseline to Week 26]

- Change from Baseline in 2-hour PPG following a mixed meal - Time Frame: Baseline to Week 26 - Safety issue: No [Time Frame: Baseline to Week 26]

- Percentage of patients with HbA1c <6.5% - Time Frame: At Week 26 - Safety issue: No [Time Frame: At Week 26]

- Percentage of patients with HbA1c <7.0% - Time Frame: At Week 26 - Safety issue: No [Time Frame: At Week 26]

- Change from Baseline in systolic blood pressure (SBP) for patients with baseline SBP =130 mmHg - Time Frame: Baseline to Week 12 - Safety issue: No [Time Frame: Baseline to Week 12]

- Change from Baseline in Fasting Plasma Glucose (FPG) - Time Frame: Baseline to Week 26 - Safety issue: No [Time Frame: Baseline to Week 26]

Secondary ID(s)

2016-001800-49

EFC14834

U1111-1181-6145

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi