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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sotagliflozin (SAR439954)

Placebo

Metformin

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 currently treated with diet and exercise and on metformin at a stable dose ≥1500 milligrams per day (mg/day) for at least 12 weeks. However, participants 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 kilograms per meter square (kg/m^2) at Screening
Hemoglobin A1c <7% or >10% via central laboratory test at screening.
Fasting plasma glucose (FPG) >15 millimole per liter (mmol/L) (270 milligrams 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.
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.
Participants 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 participants 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.
Participants 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.
Participants is unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the participants diary, or comply with study visits and other study procedures as required per protocol.
Contraindication to metformin as per local labelling.

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sotagliflozin 400 mg + Metformin

Placebo + Metformin

Arm Description

Following a 2-week run-in period, sotagliflozin 400 mg was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.

Following a 2-week run-in period, matching placebo was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26

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

Secondary Outcome Measures

Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26

An ANCOVA model was used for the analysis.

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

An ANCOVA model was used for the analysis.

Change From Baseline in Body Weight at Week 26

An ANCOVA model was used for the analysis.

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

An ANCOVA model was used for the analysis.

Change From Baseline in SBP at Week 12 for All Participants

An ANCOVA model was used for the analysis.

Percentage of Participants With HbA1c <6.5% at Week 26

Percentage of Participants With HbA1c <7.0% at Week 26

Full Information

NCT ID

NCT02926950

First Posted

October 5, 2016

Last Updated

April 16, 2021

Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02926950

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

February 26, 2019 (Actual)

Study Completion Date

March 22, 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 superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants 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 participants with baseline SBP ≥130 millimeter of mercury (mmHg). Change from baseline in SBP for all participants. Change from baseline in body weight. Proportion of participants with HbA1c <6.5% and <7.0%. To evaluate the safety of Sotagliflozin versus placebo.

Detailed Description

The duration of the study period is up to 87 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks and a 2 week single blind Run-in phase, a 26 week double-blind Core Treatment Period, a 53-week double-blind Extension Period, a 4 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

ParticipantInvestigator

Allocation

Randomized

Enrollment

518 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sotagliflozin 400 mg + Metformin

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Metformin

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)

Placebo

Intervention Description

Pharmaceutical form: tablet. Route of administration: oral.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Pharmaceutical form: tablet. Route of administration: oral.

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26

Description

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

Time Frame

Baseline and Week 26

Secondary Outcome Measure Information:

Title

Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26

Description

An ANCOVA model was used for the analysis.

Time Frame

Baseline and Week 26

Title

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Description

An ANCOVA model was used for the analysis.

Time Frame

Baseline and Week 26

Title

Change From Baseline in Body Weight at Week 26

Description

An ANCOVA model was used for the analysis.

Time Frame

Baseline and Week 26

Title

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

Description

An ANCOVA model was used for the analysis.

Time Frame

Baseline and Week 12

Title

Change From Baseline in SBP at Week 12 for All Participants

Description

An ANCOVA model was used for the analysis.

Time Frame

Baseline and Week 12

Title

Percentage of Participants With HbA1c <6.5% at Week 26

Time Frame

Week 26

Title

Percentage of Participants With HbA1c <7.0% at Week 26

Time Frame

Week 26

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]. Participants may be reported in more than one category.

Time Frame

Up to 79 weeks in the treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Participants with Type 2 Diabetes currently treated with diet and exercise and on metformin at a stable dose ≥1500 milligrams per day (mg/day) for at least 12 weeks. However, participants 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 kilograms per meter square (kg/m^2) at Screening Hemoglobin A1c <7% or >10% via central laboratory test at screening. Fasting plasma glucose (FPG) >15 millimole per liter (mmol/L) (270 milligrams 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. 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. Participants 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 participants 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. Participants 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. Participants is unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the participants diary, or comply with study visits and other study procedures as required per protocol. Contraindication to metformin as per local labelling. The above information is not intended to contain all considerations relevant to a participant's 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 8402003

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Investigational Site Number 8402017

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Investigational Site Number 8402052

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Investigational Site Number 8402056

City

Canoga Park

State/Province

California

ZIP/Postal Code

91303

Country

United States

Facility Name

Investigational Site Number 8402020

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Investigational Site Number 8402028

City

Gold River

State/Province

California

ZIP/Postal Code

95670

Country

United States

Facility Name

Investigational Site Number 8402067

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Investigational Site Number 8402025

City

Huntington Park

State/Province

California

ZIP/Postal Code

90255

Country

United States

Facility Name

Investigational Site Number 8402051

City

La Mirada

State/Province

California

ZIP/Postal Code

90638

Country

United States

Facility Name

Investigational Site Number 8402042

City

Lemon Grove

State/Province

California

ZIP/Postal Code

91945

Country

United States

Facility Name

Investigational Site Number 8402011

City

Lincoln

State/Province

California

ZIP/Postal Code

95648

Country

United States

Facility Name

Investigational Site Number 8402014

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

Investigational Site Number 8402066

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

Investigational Site Number 8402029

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

Investigational Site Number 8402041

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Investigational Site Number 8402001

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigational Site Number 8402043

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Investigational Site Number 8402031

City

San Ramon

State/Province

California

ZIP/Postal Code

94582

Country

United States

Facility Name

Investigational Site Number 8402047

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Investigational Site Number 8402009

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33472

Country

United States

Facility Name

Investigational Site Number 8402016

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Investigational Site Number 8402006

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Investigational Site Number 8402035

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Investigational Site Number 8402044

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Investigational Site Number 8402045

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Investigational Site Number 8402060

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140-3608

Country

United States

Facility Name

Investigational Site Number 8402026

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Investigational Site Number 8402036

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Investigational Site Number 8402064

City

Miami

State/Province

Florida

ZIP/Postal Code

33183

Country

United States

Facility Name

Investigational Site Number 8402007

City

Miami

State/Province

Florida

ZIP/Postal Code

33185

Country

United States

Facility Name

Investigational Site Number 8402061

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Investigational Site Number 8402033

City

Opa-locka

State/Province

Florida

ZIP/Postal Code

33054

Country

United States

Facility Name

Investigational Site Number 8402039

City

Orlando

State/Province

Florida

ZIP/Postal Code

32825

Country

United States

Facility Name

Investigational Site Number 8402063

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33406-5854

Country

United States

Facility Name

Investigational Site Number 8402038

City

Winter Haven

State/Province

Florida

ZIP/Postal Code

33880

Country

United States

Facility Name

Investigational Site Number 8402008

City

Macon

State/Province

Georgia

ZIP/Postal Code

31210

Country

United States

Facility Name

Investigational Site Number 8402054

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Investigational Site Number 8402069

City

Newton

State/Province

Iowa

ZIP/Postal Code

50208

Country

United States

Facility Name

Investigational Site Number 8402022

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50265

Country

United States

Facility Name

Investigational Site Number 8402059

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Investigational Site Number 8402068

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808-4124

Country

United States

Facility Name

Investigational Site Number 8402012

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Investigational Site Number 8402037

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119-6302

Country

United States

Facility Name

Investigational Site Number 8402053

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70124

Country

United States

Facility Name

Investigational Site Number 8402021

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Investigational Site Number 8402062

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114-3755

Country

United States

Facility Name

Investigational Site Number 8402005

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Investigational Site Number 8402018

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

Investigational Site Number 8402002

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Investigational Site Number 8402019

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Investigational Site Number 8402015

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97404-3233

Country

United States

Facility Name

Investigational Site Number 8402058

City

Lansdale

State/Province

Pennsylvania

ZIP/Postal Code

19446-1002

Country

United States

Facility Name

Investigational Site Number 8402030

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 8402050

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

Investigational Site Number 8402010

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76164

Country

United States

Facility Name

Investigational Site Number 8402040

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

Investigational Site Number 8402065

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Investigational Site Number 8402057

City

Houston

State/Province

Texas

ZIP/Postal Code

77079

Country

United States

Facility Name

Investigational Site Number 8402049

City

Magnolia

State/Province

Texas

ZIP/Postal Code

77355

Country

United States

Facility Name

Investigational Site Number 8402046

City

Odessa

State/Province

Texas

ZIP/Postal Code

79761

Country

United States

Facility Name

Investigational Site Number 8402013

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Investigational Site Number 8402004

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Investigational Site Number 8402023

City

Schertz

State/Province

Texas

ZIP/Postal Code

78154

Country

United States

Facility Name

Investigational Site Number 8402027

City

Clinton

State/Province

Utah

ZIP/Postal Code

84015

Country

United States

Facility Name

Investigational Site Number 8402032

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Investigational Site Number 8402024

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Investigational Site Number 8402034

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Investigational Site Number 1242014

City

Barrie

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

Investigational Site Number 1242004

City

Brampton

ZIP/Postal Code

L6S 0C6

Country

Canada

Facility Name

Investigational Site Number 1242005

City

Brampton

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

Investigational Site Number 1242001

City

Concord

ZIP/Postal Code

L4K 4M2

Country

Canada

Facility Name

Investigational Site Number 1242007

City

Etobicoke

ZIP/Postal Code

M9R 4E1

Country

Canada

Facility Name

Investigational Site Number 1242010

City

Levis

ZIP/Postal Code

G6W 0M5

Country

Canada

Facility Name

Investigational Site Number 1242012

City

Newmarket

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

Investigational Site Number 1242013

City

Oakville

ZIP/Postal Code

L6M 1M1

Country

Canada

Facility Name

Investigational Site Number 1242006

City

Pointe Claire

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

Investigational Site Number 1242008

City

Sherbrooke

ZIP/Postal Code

J1L 0H8

Country

Canada

Facility Name

Investigational Site Number 1242015

City

Toronto

ZIP/Postal Code

M3M 3E5

Country

Canada

Facility Name

Investigational Site Number 1242002

City

Toronto

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Investigational Site Number 1242003

City

Toronto

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

Investigational Site Number 1242011

City

Vancouver

ZIP/Postal Code

V5X 0C4

Country

Canada

Facility Name

Investigational Site Number 3482002

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Investigational Site Number 3482003

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

Investigational Site Number 3482006

City

Budapest

ZIP/Postal Code

1213

Country

Hungary

Facility Name

Investigational Site Number 3482004

City

Debrecen

ZIP/Postal Code

4025

Country

Hungary

Facility Name

Investigational Site Number 3482001

City

Esztergom

ZIP/Postal Code

2500

Country

Hungary

Facility Name

Investigational Site Number 3482007

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Investigational Site Number 7032001

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

Investigational Site Number 7032005

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

Investigational Site Number 7032003

City

Malacky

ZIP/Postal Code

901 01

Country

Slovakia

Facility Name

Investigational Site Number 7032002

City

Nitra

ZIP/Postal Code

949 11

Country

Slovakia

Facility Name

Investigational Site Number 7032004

City

Sturovo

ZIP/Postal Code

943 01

Country

Slovakia

Facility Name

Investigational Site Number 7032006

City

Trencin

ZIP/Postal Code

911 01

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 we continue to protect the privacy of the participants in our 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

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

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

Type 2 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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

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