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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2016-001800-49-HU
• Date of registration: 07/10/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi-aventis Recherche & Développement
• 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 - SOTA-MET
• Date of first enrolment: 29/11/2016
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001800-49
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Brazil, Canada, Hungary, Mexico, Slovakia, United States

Contacts

• Name: NA.
• Affiliation: sanofi-aventis Zrt.

• Name: NA.
• Affiliation: sanofi-aventis Zrt.

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.
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 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus
MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: Sotagliflozin
Product Code: SAR439954
Pharmaceutical Form: Tablet
INN or Proposed INN: SOTAGLIFLOZIN
Current Sponsor code: SAR439954
Other descriptive name: LX4211, LX-4211, LP-802034
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Change from Baseline in HbA1c

Main Objective: To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control with metformin.

Secondary Objective: -To compare sotagliflozin versus placebo for:
-Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
-Change from baseline in fasting plasma glucose (FPG);
-Change from Baseline in systolic blood pressure (SBP) for patients with baseline SBP =130 mmHg;
-Change from baseline in systolic blood pressure (SBP) for all patients;
-Change from baseline in body weight;
-Proportion of patients with HbA1c <6.5% and <7.0%.
-To evaluate the safety of sotagliflozin versus placebo.

Timepoint(s) of evaluation of this end point: Baseline to Week 26

Secondary Outcome(s)

Secondary end point(s): 1 - Change from Baseline in 2-hour PPG following a mixed meal
2- Change from Baseline in FPG
3 - Change from Baseline in SBP for patients with baseline SBP =130 mmHg
4 - Change from Baseline in SBP for all patients
5 - Change from Baseline in body weight
6 - Percentage of patients with HbA1c <6.5%
7 - Percentage of patients with HbA1c <7.0%

Timepoint(s) of evaluation of this end point: 1 - Change from Baseline in 2-hour PPG following a mixed meal : Baseline to Week 26
2- Change from Baseline in FPG : Baseline to Week 26
3 - Change from Baseline in SBP for patients with baseline SBP =130 mmHg : Baseline to Week 12
4 - Change from Baseline in SBP for all patients : Baseline to Week 12
5 - Change from Baseline in body weight : Baseline to Week 26
6 - Percentage of patients with HbA1c <6.5% : At Week 26
7 - Percentage of patients with HbA1c <7.0% : At Week 26

Secondary ID(s)

EFC14834

Source(s) of Monetary Support

Sanofi-aventis Recherche & Développement

Ethics review

Status: Approved
Approval date:
Contact: