Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy (SOTA-GLIM)

A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Glimepiride or Placebo Added to Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy

Primary Objective:

To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin.

Secondary Objectives:

To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter [mg/dL]).

• To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants.
• To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c.
• To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
• To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
• To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Sotagliflozin (SAR439954); Drug: Metformin; Drug: Placebo; Drug: Placebo; Drug: Glimepiride

Detailed Description

Up to 58 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period, and a 2-week post-treatment Follow-up period to collect safety information.

• Study Type: Interventional
• Enrollment (Actual): 954
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • Investigational Site Number 1007002
  • Plovdiv, Bulgaria, 4000
    • Investigational Site Number 1007008
  • Plovdiv, Bulgaria, 4002
    • Investigational Site Number 1007003
  • Ruse, Bulgaria, 7003
    • Investigational Site Number 1007001
  • Smolyan, Bulgaria, 4700
    • Investigational Site Number 1007004
  • Sofia, Bulgaria, 1632
    • Investigational Site Number 1007009
  • Stara Zagora, Bulgaria, 6000
    • Investigational Site Number 1007005
  • Stara Zagora, Bulgaria, 6000
    • Investigational Site Number 1007006
  • Varna, Bulgaria, 9000
    • Investigational Site Number 1007007
• Hungary
  • Balatonfured, Hungary, 8230
    • Investigational Site Number 3487005
  • Budapest, Hungary, 1033
    • Investigational Site Number 3487001
  • Budapest, Hungary, 1134
    • Investigational Site Number 3487010
  • Debrecen, Hungary, 4025
    • Investigational Site Number 3487006
  • Debrecen, Hungary, 4032
    • Investigational Site Number 3487008
  • Kecskemet, Hungary, 6000
    • Investigational Site Number 3487002
  • Nyiregyhaza, Hungary, 4405
    • Investigational Site Number 3487007
  • Nyíregyháza, Hungary, 4400
    • Investigational Site Number 3487004
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Investigational Site Number 7037004
  • Bratislava, Slovakia, 831 06
    • Investigational Site Number 7037008
  • Bratislava, Slovakia, 85101
    • Investigational Site Number 7037007
  • Kosice, Slovakia, 4014
    • Investigational Site Number 7037005
  • Levice, Slovakia, 934 01
    • Investigational Site Number 7037002
  • Nitra, Slovakia, 94901
    • Investigational Site Number 7037010
  • Roznava, Slovakia, 048 01
    • Investigational Site Number 7037009
  • Sabinov, Slovakia, 08301
    • Investigational Site Number 7037001
  • Trnava, Slovakia, 91701
    • Investigational Site Number 7037003
  • Vrutky, Slovakia, 038 61
    • Investigational Site Number 7037006
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Investigational Site Number 8407040
    • Birmingham, Alabama, United States, 35233-2110
      • Investigational Site Number 8407048
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Investigational Site Number 8407035
  • California
    • Anaheim, California, United States, 92801-2417
      • Investigational Site Number 8407051
    • Canoga Park, California, United States, 91301
      • Investigational Site Number 8407065
    • Carmichael, California, United States, 95608
      • Investigational Site Number 8407078
    • Downey, California, United States, 90242
      • Investigational Site Number 8407089
    • Gold River, California, United States, 95670
      • Investigational Site Number 8407011
    • Greenbrae, California, United States, 94904
      • Investigational Site Number 8407044
    • Huntington Park, California, United States, 90255-2911
      • Investigational Site Number 8407006
    • Lemon Grove, California, United States, 91945
      • Investigational Site Number 8407037
    • Lomita, California, United States, 90717
      • Investigational Site Number 8407100
    • Long Beach, California, United States, 90806
      • Investigational Site Number 8407033
    • Los Angeles, California, United States, 90057-3507
      • Investigational Site Number 8407019
    • Northridge, California, United States, 91325-5409
      • Investigational Site Number 8407098
    • Norwalk, California, United States, 90650
      • Investigational Site Number 8407094
    • Pomona, California, United States, 91766
      • Investigational Site Number 8407106
    • Rancho Cucamonga, California, United States, 91730
      • Investigational Site Number 8407096
    • Sacramento, California, United States, 95821
      • Investigational Site Number 8407036
    • Tarzana, California, United States, 91356-3551
      • Investigational Site Number 8407084
    • Upland, California, United States, 91786-4070
      • Investigational Site Number 8407034
    • Van Nuys, California, United States, 91405
      • Investigational Site Number 8407032
    • Walnut Creek, California, United States, 94598
      • Investigational Site Number 8407004
    • Wildomar, California, United States, 92595
      • Investigational Site Number 8407117
  • Colorado
    • Colorado Springs, Colorado, United States, 80920-8075
      • Investigational Site Number 8407045
  • Florida
    • Bradenton, Florida, United States, 34201
      • Investigational Site Number 8407074
    • Clearwater, Florida, United States, 33761
      • Investigational Site Number 8407027
    • Cooper City, Florida, United States, 33024
      • Investigational Site Number 8407103
    • Coral Gables, Florida, United States, 33134
      • Investigational Site Number 8407021
    • Lake Worth, Florida, United States, 33467
      • Investigational Site Number 8407062
    • Ocoee, Florida, United States, 34761
      • Investigational Site Number 8407121
    • Orlando, Florida, United States, 32825-4454
      • Investigational Site Number 8407024
    • Palmetto Bay, Florida, United States, 33157-5503
      • Investigational Site Number 8407038
    • Pembroke Pines, Florida, United States, 33026-3924
      • Investigational Site Number 8407093
    • Spring Hill, Florida, United States, 34609
      • Investigational Site Number 8407107
    • Tampa, Florida, United States, 33619
      • Investigational Site Number 8407091
    • Tampa, Florida, United States, 33634
      • Investigational Site Number 8407113
    • West Palm Beach, Florida, United States, 33401
      • Investigational Site Number 8407092
    • Winter Haven, Florida, United States, 33880
      • Investigational Site Number 8407115
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Investigational Site Number 8407017
    • Elgin, Illinois, United States, 60124
      • Investigational Site Number 8407018
    • Gurnee, Illinois, United States, 60031
      • Investigational Site Number 8407046
    • Springfield, Illinois, United States, 62711
      • Investigational Site Number 8407119
  • Iowa
    • Waterloo, Iowa, United States, 50702
      • Investigational Site Number 8407075
    • West Des Moines, Iowa, United States, 50265
      • Investigational Site Number 8407120
  • Kansas
    • Topeka, Kansas, United States, 66606-2806
      • Investigational Site Number 8407095
    • Wichita, Kansas, United States, 67205-1138
      • Investigational Site Number 8407083
  • Kentucky
    • Lexington, Kentucky, United States, 40503-2517
      • Investigational Site Number 8407043
    • Lexington, Kentucky, United States, 40503
      • Investigational Site Number 8407087
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Investigational Site Number 8407060
    • New Orleans, Louisiana, United States, 70119
      • Investigational Site Number 8407058
    • New Orleans, Louisiana, United States, 70124
      • Investigational Site Number 8407009
    • Zachary, Louisiana, United States, 70791-4010
      • Investigational Site Number 8407079
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Investigational Site Number 8407085
    • Rockville, Maryland, United States, 20852
      • Investigational Site Number 8407001
  • Michigan
    • Troy, Michigan, United States, 48098-6334
      • Investigational Site Number 8407069
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Investigational Site Number 8407110
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Investigational Site Number 8407054
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Investigational Site Number 8407049
    • Omaha, Nebraska, United States, 68114
      • Investigational Site Number 8407039
    • Papillion, Nebraska, United States, 68046-3136
      • Investigational Site Number 8407061
  • Nevada
    • Las Vegas, Nevada, United States, 89106-4132
      • Investigational Site Number 8407108
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Investigational Site Number 8407050
  • New York
    • New York, New York, United States, 10016-6402
      • Investigational Site Number 8407116
    • New York, New York, United States, 10029
      • Investigational Site Number 8407086
    • New York, New York, United States, 10036
      • Investigational Site Number 8407122
    • West Seneca, New York, United States, 14224
      • Investigational Site Number 8407123
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Investigational Site Number 8407020
    • Lenoir, North Carolina, United States, 28645-8981
      • Investigational Site Number 8407114
    • Morehead City, North Carolina, United States, 28557
      • Investigational Site Number 8407015
    • Salisbury, North Carolina, United States, 28144-2742
      • Investigational Site Number 8407030
    • Wilmington, North Carolina, United States, 28401-6638
      • Investigational Site Number 8407041
    • Winston-Salem, North Carolina, United States, 27103
      • Investigational Site Number 8407101
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Investigational Site Number 8407099
    • Lyndhurst, Ohio, United States, 44124-2467
      • Investigational Site Number 8407081
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Investigational Site Number 8407057
    • Oklahoma City, Oklahoma, United States, 73104-3252
      • Investigational Site Number 8407073
  • Oregon
    • Eugene, Oregon, United States, 97404
      • Investigational Site Number 8407068
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009-1957
      • Investigational Site Number 8407104
    • Hatboro, Pennsylvania, United States, 19040-2045
      • Investigational Site Number 8407025
    • Lansdale, Pennsylvania, United States, 19446-1002
      • Investigational Site Number 8407053
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Investigational Site Number 8407016
    • Greer, South Carolina, United States, 29651-1817
      • Investigational Site Number 8407071
    • Mount Pleasant, South Carolina, United States, 29464
      • Investigational Site Number 8407022
    • Mount Pleasant, South Carolina, United States, 29464
      • Investigational Site Number 8407031
  • Tennessee
    • Jefferson City, Tennessee, United States, 37760
      • Investigational Site Number 8407014
    • Knoxville, Tennessee, United States, 37938
      • Investigational Site Number 8407002
    • Memphis, Tennessee, United States, 38163
      • Investigational Site Number 8407056
  • Texas
    • Austin, Texas, United States, 78735-8982
      • Investigational Site Number 8407026
    • Beaumont, Texas, United States, 77702
      • Investigational Site Number 8407029
    • Carrollton, Texas, United States, 75010
      • Investigational Site Number 8407070
    • Corpus Christi, Texas, United States, 78414-4173
      • Investigational Site Number 8407102
    • Dallas, Texas, United States, 75230
      • Investigational Site Number 8407023
    • Dallas, Texas, United States, 75231
      • Investigational Site Number 8407111
    • Fort Worth, Texas, United States, 76164
      • Investigational Site Number 8407013
    • Houston, Texas, United States, 77040
      • Investigational Site Number 8407080
    • Houston, Texas, United States, 77095-2856
      • Investigational Site Number 8407088
    • Katy, Texas, United States, 77450
      • Investigational Site Number 8407090
    • Lampasas, Texas, United States, 76550-1820
      • Investigational Site Number 8407042
    • Lufkin, Texas, United States, 75904
      • Investigational Site Number 8407067
    • Lufkin, Texas, United States, 75904
      • Investigational Site Number 8407118
    • McAllen, Texas, United States, 78504
      • Investigational Site Number 8407059
    • Mesquite, Texas, United States, 75149
      • Investigational Site Number 8407012
    • Plano, Texas, United States, 75075
      • Investigational Site Number 8407007
    • San Antonio, Texas, United States, 78218
      • Investigational Site Number 8407005
    • San Antonio, Texas, United States, 78229-3818
      • Investigational Site Number 8407064
    • Schertz, Texas, United States, 78154
      • Investigational Site Number 8407010
    • Splendora, Texas, United States, 77372
      • Investigational Site Number 8407076
  • Utah
    • Clinton, Utah, United States, 84015
      • Investigational Site Number 8407063
    • Holladay, Utah, United States, 84117-7054
      • Investigational Site Number 8407055
    • Ogden, Utah, United States, 84405
      • Investigational Site Number 8407097
    • Salt Lake City, Utah, United States, 84102-1553
      • Investigational Site Number 8407072
  • Virginia
    • Manassas, Virginia, United States, 20110-4421
      • Investigational Site Number 8407124
    • Richmond, Virginia, United States, 23249-0001
      • Investigational Site Number 8407105
  • Washington
    • Renton, Washington, United States, 98055
      • Investigational Site Number 8407028

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• Participants with Type 2 Diabetes (T2D) treated with metformin at a stable dose ≥1500 milligrams per day (mg/day) or maximum tolerated dose (documented) for at least 12 weeks prior to Screening Visit; in case of documented lack of tolerance, metformin dose <1500 mg/day is acceptable, and the dose should be stable for at least 12 weeks prior to Screening Visit.
• Participants has given written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

• Age <18 years at the Screening Visit or <legal age of majority, whichever is greater.
• Type 1 diabetes mellitus.
• HbA1c, HbA1c <7.0% or HbA1c >10% at Screening.
• Fasting Plasma Glucose (FPG) >15 millimoles per liter (mmol/L) (>270 milligram per deciliter [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.
• Body mass index ≤20 or >45 kilogram per meter square (kg/m^2) at Screening.
• Pregnant (confirmed by pregnancy test at the Screening) or breast-feeding women.
• Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy (see Appendix A) during the study.
• Previous use of any antidiabetic drug other than Metformin within 12 weeks preceding the Screening Visit.
• Use of a selective Sodium-glucose co-transporter-2 (SGLT2) inhibitor (e.g., Canagliflozin, Dapagliflozin, or Empagliflozin) within 3 months prior to the Screening visit.
• Use of systemic glucocorticoids (excluding topical, or ophthalmic application, intra-articular, nasal spray or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
• Previous insulin use >1 month (at any time, except for treatment of gestational diabetes).
• History of prior gastric surgical procedure, including gastric banding, or inflammatory bowel disease within 3 years prior to the Screening Visit.
• Difficulty swallowing such that the participants cannot take the investigational medicinal product (IMP).
• History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
• Mean of 3 separate blood pressure measurements >180 millimeter of mercury (mmHg) (SBP) or >100 mmHg (DBP).
• History of hypertensive emergency within 12 weeks prior to Screening.
• Participants who have previously been randomized in any clinical trial of Sotagliflozin/LX4211.
• Participants with severe renal disease as defined by an estimated glomerular filtration rate (eGFR) of <30 milliliter per minute per meter square (mL/min/1.73 m^2) at Screening, based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation (or according to the renal function restrictions of metformin use defined in the local approved label).
• Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease that, according to Investigator, will preclude their safe participation in this study, or will make 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 (ULN).
• Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome).
• Participants who have taken other investigational drugs within 12 weeks or 5 half-lives from Screening whichever is longer.
• Participants unwilling or unable to perform self-monitoring blood glucose (SMBG), complete the participant diary, or comply with study visits and other study procedures as required per protocol.
• Participants with contraindication to glimepiride as per local labelling.
• Participants with contraindication to metformin as per local labelling.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sotagliflozin 400 mg; Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Drug: Sotagliflozin (SAR439954); Pharmaceutical form: tablet Route of administration: oral; Drug: Metformin; Pharmaceutical form: tablet Route of administration: oral; Drug: Placebo; Pharmaceutical form: tablet Route of administration: oral; Drug: Placebo; Pharmaceutical form: capsule Route of administration: oral
Experimental: Sotagliflozin 200 mg; Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Drug: Sotagliflozin (SAR439954); Pharmaceutical form: tablet Route of administration: oral; Drug: Metformin; Pharmaceutical form: tablet Route of administration: oral; Drug: Placebo; Pharmaceutical form: tablet Route of administration: oral; Drug: Placebo; Pharmaceutical form: capsule Route of administration: oral
Active Comparator: Glimepiride; Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Drug: Metformin; Pharmaceutical form: tablet Route of administration: oral; Drug: Placebo; Pharmaceutical form: tablet Route of administration: oral; Drug: Placebo; Pharmaceutical form: capsule Route of administration: oral; Drug: Glimepiride; Pharmaceutical form: capsule Route of administration: oral
Placebo Comparator: Placebo; Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Drug: Metformin; Pharmaceutical form: tablet Route of administration: oral; Drug: Placebo; Pharmaceutical form: tablet Route of administration: oral; Drug: Placebo; Pharmaceutical form: capsule Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c at Week 52	An analysis of covariance (ANCOVA) model was used for the analysis.	Baseline, Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c at Week 26	An ANCOVA model was used for the analysis.	Baseline, Week 26
Change From Baseline in Body Weight at Week 26 and 52	An ANCOVA model was used for the analysis.	Baseline, Week 26, Week 52
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12	An ANCOVA model was used for the analysis.	Baseline, Week 12
Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12	An ANCOVA model was used for the analysis.	Baseline, Week 12
Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event	Documented symptomatic hypoglycemia includes the typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L).	Up to Week 52
Percentage of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.	Up to Week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Hypoglycemic Events	Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].	Up to Week 52

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): September 6, 2019

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Sodium-Glucose Transporter 2 Inhibitors; Metformin; Glimepiride; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
• Other Study ID Numbers: EFC14838; 2016-001801-17 (EudraCT Number); U1111-1190-7596 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No