Clinical Trial Details

NCT ID: NCT02926950
Date Last Changed: June 27, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Sotagliflozin (SAR439954), Placebo and Metformin to evaluate Type 2 Diabetes Mellitus

Research Study 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

Purpose

Primary 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 Objectives:

  • 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 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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Sanofi
Duration
28 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

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.

Site Locations (93)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35205 Investigational Site Number 8402003
United States Alabama Birmingham 35294 Investigational Site Number 8402017
United States Arizona Phoenix 85018-8313 Investigational Site Number 8402052
United States California Canoga Park 91303-1844 Investigational Site Number 8402056
United States California Escondido 92026-3923 Investigational Site Number 8402020
United States California Gold River 95670-4344 Investigational Site Number 8402028
United States California Greenbrae 94904 Investigational Site Number 8402067
United States California Huntington Park 90255 Investigational Site Number 8402025
United States California La Mirada 90638 Investigational Site Number 8402051
United States California Lincoln 95648-1839 Investigational Site Number 8402011
United States California Long Beach 90806 Investigational Site Number 8402014
United States California Long Beach 90806 Investigational Site Number 8402066
United States California Los Angeles 90022-4302 Investigational Site Number 8402029
United States California Los Angeles 90036-4664 Investigational Site Number 8402041
United States California Los Angeles 90057 Investigational Site Number 8402001
United States California National City 91950-7628 Investigational Site Number 8402042
United States California San Diego 92103-2209 Investigational Site Number 8402043
United States California San Ramon 94582-4826 Investigational Site Number 8402031
United States California Tarzana 91356-3551 Investigational Site Number 8402047
United States Florida Boynton Beach 33472 Investigational Site Number 8402009
United States Florida Daytona Beach 32117-5146 Investigational Site Number 8402016
United States Florida Hialeah 33012-3407 Investigational Site Number 8402035
United States Florida Hialeah 33012-7194 Investigational Site Number 8402044
United States Florida Hialeah 33012 Investigational Site Number 8402006
United States Florida Jacksonville 32256 Investigational Site Number 8402045
United States Florida Lauderdale Lakes 33319-5800 Investigational Site Number 8402063
United States Florida Miami Beach 33140-3608 Investigational Site Number 8402060
United States Florida Miami 33126 Investigational Site Number 8402026
United States Florida Miami 33175 Investigational Site Number 8402007
United States Florida Miami 33183-4825 Investigational Site Number 8402064
United States Florida Miami 33186-5863 Investigational Site Number 8402061
United States Florida Opa-locka 33054-3818 Investigational Site Number 8402033
United States Florida Orlando 32825-4454 Investigational Site Number 8402039
United States Florida South Miami 33143-5026 Investigational Site Number 8402036
United States Florida Winter Haven 33880-3053 Investigational Site Number 8402038
United States Georgia Macon 31210-1359 Investigational Site Number 8402008
United States Illinois Chicago 60827 Investigational Site Number 8402054
United States Iowa Des Moines 50314 Investigational Site Number 8402022
United States Iowa Newton 50208 Investigational Site Number 8402069
United States Kentucky Lexington 40503-2502 Investigational Site Number 8402059
United States Louisiana Baton Rouge 70808-4124 Investigational Site Number 8402068
United States Louisiana Metairie 70006-2930 Investigational Site Number 8402012
United States Louisiana New Orleans 70115 Investigational Site Number 8402053
United States Louisiana New Orleans 70119-6302 Investigational Site Number 8402037
United States Maryland Rockville 20852-4267 Investigational Site Number 8402021
United States Nebraska Omaha 68114-3755 Investigational Site Number 8402062
United States Nevada Las Vegas 89148 Investigational Site Number 8402005
United States North Carolina Greensboro 27401-1033 Investigational Site Number 8402018
United States North Carolina Morehead City 28557-3126 Investigational Site Number 8402002
United States Oklahoma Oklahoma City 73104 Investigational Site Number 8402019
United States Oregon Eugene 97404-3233 Investigational Site Number 8402015
United States Pennsylvania Lansdale 19446-1002 Investigational Site Number 8402058
United States Texas Dallas 75230-6885 Investigational Site Number 8402030
United States Texas DeSoto 75115 Investigational Site Number 8402050
United States Texas Fort Worth 76164 Investigational Site Number 8402010
United States Texas Houston 77008-2436 Investigational Site Number 8402040
United States Texas Houston 77058 Investigational Site Number 8402065
United States Texas Houston 77079-2212 Investigational Site Number 8402057
United States Texas Magnolia 77355 Investigational Site Number 8402049
United States Texas Odessa 79761-5133 Investigational Site Number 8402046
United States Texas San Antonio 78218 Investigational Site Number 8402013
United States Texas San Antonio 78229-3907 Investigational Site Number 8402004
United States Texas Schertz 78154-1403 Investigational Site Number 8402023
United States Utah Clinton 84015-8638 Investigational Site Number 8402027
United States Utah Salt Lake City 84107-2518 Investigational Site Number 8402032
United States Virginia Virginia Beach 23454-3075 Investigational Site Number 8402024
United States Washington Seattle 98105-6008 Investigational Site Number 8402034
Canada Brampton L6T 0G1 Investigational Site Number 1242005
Canada Calgary T2H 2G4 Investigational Site Number 1242001
Canada Calgary T2H 2G4 Investigational Site Number 1242002
Canada Calgary T2H 2G4 Investigational Site Number 1242003
Canada Calgary T2H 2G4 Investigational Site Number 1242004
Canada Calgary T2H 2G4 Investigational Site Number 1242007
Canada Calgary T2H 2G4 Investigational Site Number 1242013
Canada Calgary T2H 2G4 Investigational Site Number 1242014
Canada Montreal H3G 1L5 Investigational Site Number 1242008
Canada Newmarket L3Y 5G8 Investigational Site Number 1242012
Canada Saint-Romuald G6W 5M6 Investigational Site Number 1242010
Canada Toronto M3M 3E5 Investigational Site Number 1242015
Canada Toronto M9W 4L6 Investigational Site Number 1242006
Canada Toronto M9W 4L6 Investigational Site Number 1242011
Hungary Budapest 1033 Investigational Site Number 3482002
Hungary Budapest 1085 Investigational Site Number 3482003
Hungary Budapest 1213 Investigational Site Number 3482006
Hungary Debrecen 4025 Investigational Site Number 3482004
Hungary Esztergom 2500 Investigational Site Number 3482001
Hungary Nyíregyháza 4400 Investigational Site Number 3482007
Slovakia Bratislava 851 01 Investigational Site Number 7032001
Slovakia Bratislava 851 01 Investigational Site Number 7032005
Slovakia Malacky 901 01 Investigational Site Number 7032003
Slovakia Nitra 949 11 Investigational Site Number 7032002
Slovakia Sturovo 943 01 Investigational Site Number 7032004
Slovakia Trencin 911 01 Investigational Site Number 7032006

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