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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sotagliflozin (SAR439954)

Glimepiride

Metformin

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Sotagliflozin 400 mg

Sotagliflozin 200 mg

Glimepiride

Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c at Week 52

An analysis of covariance (ANCOVA) model was used for the analysis.

Secondary Outcome Measures

Change From Baseline in Hemoglobin A1c at Week 26

An ANCOVA model was used for the analysis.

Change From Baseline in Body Weight at Week 26 and 52

An ANCOVA model was used for the analysis.

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.

Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12

An ANCOVA model was used for the analysis.

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).

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.

Full Information

NCT ID

NCT03332771

First Posted

November 2, 2017

Last Updated

April 16, 2021

Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03332771

Brief Title

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

Acronym

SOTA-GLIM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

August 6, 2019 (Actual)

Study Completion Date

September 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

954 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sotagliflozin 400 mg

Arm Type

Experimental

Arm Description

Arm Title

Sotagliflozin 200 mg

Arm Type

Experimental

Arm Description

Arm Title

Glimepiride

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sotagliflozin (SAR439954)

Intervention Description

Pharmaceutical form: tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

Glimepiride

Intervention Description

Pharmaceutical form: capsule Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Pharmaceutical form: tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical form: tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical form: capsule Route of administration: oral

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin A1c at Week 52

Description

An analysis of covariance (ANCOVA) model was used for the analysis.

Time Frame

Baseline, Week 52

Secondary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin A1c at Week 26

Description

An ANCOVA model was used for the analysis.

Time Frame

Baseline, Week 26

Title

Change From Baseline in Body Weight at Week 26 and 52

Description

An ANCOVA model was used for the analysis.

Time Frame

Baseline, Week 26, Week 52

Title

Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12

Description

An ANCOVA model was used for the analysis.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12

Description

An ANCOVA model was used for the analysis.

Time Frame

Baseline, Week 12

Title

Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event

Description

Time Frame

Up to Week 52

Title

Percentage of Participants With Adverse Events (AEs)

Description

Time Frame

Up to Week 52

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Hypoglycemic Events

Description

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].

Time Frame

Up to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suman Wason, MD

Organizational Affiliation

Lexicon Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 8407040

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Investigational Site Number 8407048

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233-2110

Country

United States

Facility Name

Investigational Site Number 8407035

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

Investigational Site Number 8407051

City

Anaheim

State/Province

California

ZIP/Postal Code

92801-2417

Country

United States

Facility Name

Investigational Site Number 8407065

City

Canoga Park

State/Province

California

ZIP/Postal Code

91301

Country

United States

Facility Name

Investigational Site Number 8407078

City

Carmichael

State/Province

California

ZIP/Postal Code

95608

Country

United States

Facility Name

Investigational Site Number 8407089

City

Downey

State/Province

California

ZIP/Postal Code

90242

Country

United States

Facility Name

Investigational Site Number 8407011

City

Gold River

State/Province

California

ZIP/Postal Code

95670

Country

United States

Facility Name

Investigational Site Number 8407044

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Investigational Site Number 8407006

City

Huntington Park

State/Province

California

ZIP/Postal Code

90255-2911

Country

United States

Facility Name

Investigational Site Number 8407037

City

Lemon Grove

State/Province

California

ZIP/Postal Code

91945

Country

United States

Facility Name

Investigational Site Number 8407100

City

Lomita

State/Province

California

ZIP/Postal Code

90717

Country

United States

Facility Name

Investigational Site Number 8407033

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Investigational Site Number 8407019

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057-3507

Country

United States

Facility Name

Investigational Site Number 8407098

City

Northridge

State/Province

California

ZIP/Postal Code

91325-5409

Country

United States

Facility Name

Investigational Site Number 8407094

City

Norwalk

State/Province

California

ZIP/Postal Code

90650

Country

United States

Facility Name

Investigational Site Number 8407106

City

Pomona

State/Province

California

ZIP/Postal Code

91766

Country

United States

Facility Name

Investigational Site Number 8407096

City

Rancho Cucamonga

State/Province

California

ZIP/Postal Code

91730

Country

United States

Facility Name

Investigational Site Number 8407036

City

Sacramento

State/Province

California

ZIP/Postal Code

95821

Country

United States

Facility Name

Investigational Site Number 8407084

City

Tarzana

State/Province

California

ZIP/Postal Code

91356-3551

Country

United States

Facility Name

Investigational Site Number 8407034

City

Upland

State/Province

California

ZIP/Postal Code

91786-4070

Country

United States

Facility Name

Investigational Site Number 8407032

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

Investigational Site Number 8407004

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Investigational Site Number 8407117

City

Wildomar

State/Province

California

ZIP/Postal Code

92595

Country

United States

Facility Name

Investigational Site Number 8407045

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80920-8075

Country

United States

Facility Name

Investigational Site Number 8407074

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34201

Country

United States

Facility Name

Investigational Site Number 8407027

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

Investigational Site Number 8407103

City

Cooper City

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Investigational Site Number 8407021

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Investigational Site Number 8407062

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33467

Country

United States

Facility Name

Investigational Site Number 8407121

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Investigational Site Number 8407024

City

Orlando

State/Province

Florida

ZIP/Postal Code

32825-4454

Country

United States

Facility Name

Investigational Site Number 8407038

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157-5503

Country

United States

Facility Name

Investigational Site Number 8407093

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026-3924

Country

United States

Facility Name

Investigational Site Number 8407107

City

Spring Hill

State/Province

Florida

ZIP/Postal Code

34609

Country

United States

Facility Name

Investigational Site Number 8407091

City

Tampa

State/Province

Florida

ZIP/Postal Code

33619

Country

United States

Facility Name

Investigational Site Number 8407113

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Facility Name

Investigational Site Number 8407092

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Investigational Site Number 8407115

City

Winter Haven

State/Province

Florida

ZIP/Postal Code

33880

Country

United States

Facility Name

Investigational Site Number 8407017

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Investigational Site Number 8407018

City

Elgin

State/Province

Illinois

ZIP/Postal Code

60124

Country

United States

Facility Name

Investigational Site Number 8407046

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

Facility Name

Investigational Site Number 8407119

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62711

Country

United States

Facility Name

Investigational Site Number 8407075

City

Waterloo

State/Province

Iowa

ZIP/Postal Code

50702

Country

United States

Facility Name

Investigational Site Number 8407120

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50265

Country

United States

Facility Name

Investigational Site Number 8407095

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606-2806

Country

United States

Facility Name

Investigational Site Number 8407083

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205-1138

Country

United States

Facility Name

Investigational Site Number 8407043

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503-2517

Country

United States

Facility Name

Investigational Site Number 8407087

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Investigational Site Number 8407060

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Investigational Site Number 8407058

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Name

Investigational Site Number 8407009

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70124

Country

United States

Facility Name

Investigational Site Number 8407079

City

Zachary

State/Province

Louisiana

ZIP/Postal Code

70791-4010

Country

United States

Facility Name

Investigational Site Number 8407085

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Investigational Site Number 8407001

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Investigational Site Number 8407069

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098-6334

Country

United States

Facility Name

Investigational Site Number 8407110

City

Olive Branch

State/Province

Mississippi

ZIP/Postal Code

38654

Country

United States

Facility Name

Investigational Site Number 8407054

City

Bridgeton

State/Province

Missouri

ZIP/Postal Code

63044

Country

United States

Facility Name

Investigational Site Number 8407049

City

Norfolk

State/Province

Nebraska

ZIP/Postal Code

68701

Country

United States

Facility Name

Investigational Site Number 8407039

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Investigational Site Number 8407061

City

Papillion

State/Province

Nebraska

ZIP/Postal Code

68046-3136

Country

United States

Facility Name

Investigational Site Number 8407108

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106-4132

Country

United States

Facility Name

Investigational Site Number 8407050

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Investigational Site Number 8407116

City

New York

State/Province

New York

ZIP/Postal Code

10016-6402

Country

United States

Facility Name

Investigational Site Number 8407086

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Investigational Site Number 8407122

City

New York

State/Province

New York

ZIP/Postal Code

10036

Country

United States

Facility Name

Investigational Site Number 8407123

City

West Seneca

State/Province

New York

ZIP/Postal Code

14224

Country

United States

Facility Name

Investigational Site Number 8407020

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Investigational Site Number 8407114

City

Lenoir

State/Province

North Carolina

ZIP/Postal Code

28645-8981

Country

United States

Facility Name

Investigational Site Number 8407015

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Investigational Site Number 8407030

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144-2742

Country

United States

Facility Name

Investigational Site Number 8407041

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401-6638

Country

United States

Facility Name

Investigational Site Number 8407101

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Investigational Site Number 8407099

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Investigational Site Number 8407081

City

Lyndhurst

State/Province

Ohio

ZIP/Postal Code

44124-2467

Country

United States

Facility Name

Investigational Site Number 8407057

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Investigational Site Number 8407073

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104-3252

Country

United States

Facility Name

Investigational Site Number 8407068

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97404

Country

United States

Facility Name

Investigational Site Number 8407104

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009-1957

Country

United States

Facility Name

Investigational Site Number 8407025

City

Hatboro

State/Province

Pennsylvania

ZIP/Postal Code

19040-2045

Country

United States

Facility Name

Investigational Site Number 8407053

City

Lansdale

State/Province

Pennsylvania

ZIP/Postal Code

19446-1002

Country

United States

Facility Name

Investigational Site Number 8407016

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Investigational Site Number 8407071

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651-1817

Country

United States

Facility Name

Investigational Site Number 8407022

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Investigational Site Number 8407031

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Investigational Site Number 8407014

City

Jefferson City

State/Province

Tennessee

ZIP/Postal Code

37760

Country

United States

Facility Name

Investigational Site Number 8407002

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37938

Country

United States

Facility Name

Investigational Site Number 8407056

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38163

Country

United States

Facility Name

Investigational Site Number 8407026

City

Austin

State/Province

Texas

ZIP/Postal Code

78735-8982

Country

United States

Facility Name

Investigational Site Number 8407029

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77702

Country

United States

Facility Name

Investigational Site Number 8407070

City

Carrollton

State/Province

Texas

ZIP/Postal Code

75010

Country

United States

Facility Name

Investigational Site Number 8407102

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78414-4173

Country

United States

Facility Name

Investigational Site Number 8407023

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 8407111

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Investigational Site Number 8407013

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76164

Country

United States

Facility Name

Investigational Site Number 8407080

City

Houston

State/Province

Texas

ZIP/Postal Code

77040

Country

United States

Facility Name

Investigational Site Number 8407088

City

Houston

State/Province

Texas

ZIP/Postal Code

77095-2856

Country

United States

Facility Name

Investigational Site Number 8407090

City

Katy

State/Province

Texas

ZIP/Postal Code

77450

Country

United States

Facility Name

Investigational Site Number 8407042

City

Lampasas

State/Province

Texas

ZIP/Postal Code

76550-1820

Country

United States

Facility Name

Investigational Site Number 8407067

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

Investigational Site Number 8407118

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

Investigational Site Number 8407059

City

McAllen

State/Province

Texas

ZIP/Postal Code

78504

Country

United States

Facility Name

Investigational Site Number 8407012

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75149

Country

United States

Facility Name

Investigational Site Number 8407007

City

Plano

State/Province

Texas

ZIP/Postal Code

75075

Country

United States

Facility Name

Investigational Site Number 8407005

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Investigational Site Number 8407064

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-3818

Country

United States

Facility Name

Investigational Site Number 8407010

City

Schertz

State/Province

Texas

ZIP/Postal Code

78154

Country

United States

Facility Name

Investigational Site Number 8407076

City

Splendora

State/Province

Texas

ZIP/Postal Code

77372

Country

United States

Facility Name

Investigational Site Number 8407063

City

Clinton

State/Province

Utah

ZIP/Postal Code

84015

Country

United States

Facility Name

Investigational Site Number 8407055

City

Holladay

State/Province

Utah

ZIP/Postal Code

84117-7054

Country

United States

Facility Name

Investigational Site Number 8407097

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

Investigational Site Number 8407072

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102-1553

Country

United States

Facility Name

Investigational Site Number 8407124

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110-4421

Country

United States

Facility Name

Investigational Site Number 8407105

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249-0001

Country

United States

Facility Name

Investigational Site Number 8407028

City

Renton

State/Province

Washington

ZIP/Postal Code

98055

Country

United States

Facility Name

Investigational Site Number 1007002

City

Gabrovo

ZIP/Postal Code

5300

Country

Bulgaria

Facility Name

Investigational Site Number 1007008

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Investigational Site Number 1007003

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Investigational Site Number 1007001

City

Ruse

ZIP/Postal Code

7003

Country

Bulgaria

Facility Name

Investigational Site Number 1007004

City

Smolyan

ZIP/Postal Code

4700

Country

Bulgaria

Facility Name

Investigational Site Number 1007009

City

Sofia

ZIP/Postal Code

1632

Country

Bulgaria

Facility Name

Investigational Site Number 1007005

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Investigational Site Number 1007006

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Investigational Site Number 1007007

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Investigational Site Number 3487005

City

Balatonfured

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Investigational Site Number 3487001

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Investigational Site Number 3487010

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Investigational Site Number 3487006

City

Debrecen

ZIP/Postal Code

4025

Country

Hungary

Facility Name

Investigational Site Number 3487008

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Investigational Site Number 3487002

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Investigational Site Number 3487007

City

Nyiregyhaza

ZIP/Postal Code

4405

Country

Hungary

Facility Name

Investigational Site Number 3487004

City

Nyíregyháza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Investigational Site Number 7037004

City

Bardejov

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Investigational Site Number 7037008

City

Bratislava

ZIP/Postal Code

831 06

Country

Slovakia

Facility Name

Investigational Site Number 7037007

City

Bratislava

ZIP/Postal Code

85101

Country

Slovakia

Facility Name

Investigational Site Number 7037005

City

Kosice

ZIP/Postal Code

4014

Country

Slovakia

Facility Name

Investigational Site Number 7037002

City

Levice

ZIP/Postal Code

934 01

Country

Slovakia

Facility Name

Investigational Site Number 7037010

City

Nitra

ZIP/Postal Code

94901

Country

Slovakia

Facility Name

Investigational Site Number 7037009

City

Roznava

ZIP/Postal Code

048 01

Country

Slovakia

Facility Name

Investigational Site Number 7037001

City

Sabinov

ZIP/Postal Code

08301

Country

Slovakia

Facility Name

Investigational Site Number 7037003

City

Trnava

ZIP/Postal Code

91701

Country

Slovakia

Facility Name

Investigational Site Number 7037006

City

Vrutky

ZIP/Postal Code

038 61

Country

Slovakia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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

Type 2 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial