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Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sotagliflozin (SAR439954)

Placebo

Metformin

Sulfonylurea

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 T2D treated with a Sulfonylurea (≥half the maximum recommended dose as per local label or maximum tolerated dose [documented]) as monotherapy or in combination with Metformin (≥1500 mg per day or maximum tolerated dose [documented]) each at a stable dose for at least 12 weeks without a dose adjustment before screening.
Signed written informed consent.

Exclusion criteria:

At the time of screening, age <18 years or < legal age of majority, whichever is greater.
Body Mass Index (BMI) ≤20 or >45 kilograms per meter square (kg/m^2) at Screening.
Hemoglobin A1c (HbA1c) <7% or HbA1c >10% via central lab test at screening.
Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
Women of childbearing potential with no effective contraceptive method.
Treated with an antidiabetic pharmacological regimen other than a Sulfonylurea at a stable dose with or without Metformin within 12 weeks preceding the screening visit.
Previous insulin use >1 month (at any time, aside from treatment of gestational diabetes).
History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit.
History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
History of severe hypoglycemia within 6 months prior to the Screening visit.
Systolic blood pressure (SBP) >180 millimeter per mercury (mmHg) or diastolic blood pressure (DBP) >100 mmHg or history of hypertensive emergency.
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).
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.
Pregnancy, breastfeeding.
Participants is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the participant's diary as required per protocol.

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

Placebo

Arm Description

Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 mg, orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.

Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.

Outcomes

Primary Outcome Measures

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

Missing data are imputed using the retrieved dropouts imputation method. An analysis of covariance (ANCOVA) model was used for the analysis.

Secondary Outcome Measures

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

Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.

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

Missing data are imputed using the washout imputation method under the missing, not at random framework. An ANCOVA model was used for the analysis.

Change From Baseline in SBP at Week 12 for All Participants

Missing data are imputed using washout imputation method under the missing not at random framework. An ANCOVA model was used for the analysis.

Change From Baseline in Body Weight at Week 26

Missing data are imputed using the retrieved dropouts imputation method. 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

NCT03066830

First Posted

February 24, 2017

Last Updated

April 16, 2021

Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03066830

Brief Title

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

Official Title

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea Alone or in Combination With Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or With Metformin

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

February 24, 2017 (Actual)

Primary Completion Date

April 17, 2019 (Actual)

Study Completion Date

April 30, 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 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin. Secondary Objectives: To compare Sotagliflozin 400 mg versus placebo based on: 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 (mm Hg). Change from baseline in SBP for all participants. Change from baseline in body weight. Percentage of participants with HbA1c <6.5% and <7.0%. To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.

Detailed Description

The duration per participants is up to 85 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, 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

ParticipantInvestigator

Allocation

Randomized

Enrollment

507 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sotagliflozin 400 mg

Arm Type

Experimental

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)

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

Intervention Type

Drug

Intervention Name(s)

Sulfonylurea

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

Missing data are imputed using the retrieved dropouts imputation method. An analysis of covariance (ANCOVA) model was used for the analysis.

Time Frame

Baseline to Week 26

Secondary Outcome Measure Information:

Title

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

Description

Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.

Time Frame

Baseline to Week 26

Title

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

Description

Missing data are imputed using the washout imputation method under the missing, not at random framework. An ANCOVA model was used for the analysis.

Time Frame

Baseline to Week 12

Title

Change From Baseline in SBP at Week 12 for All Participants

Description

Missing data are imputed using washout imputation method under the missing not at random framework. An ANCOVA model was used for the analysis.

Time Frame

Baseline to Week 12

Title

Change From Baseline in Body Weight at Week 26

Description

Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.

Time Frame

Baseline to Week 26

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 T2D treated with a Sulfonylurea (≥half the maximum recommended dose as per local label or maximum tolerated dose [documented]) as monotherapy or in combination with Metformin (≥1500 mg per day or maximum tolerated dose [documented]) each at a stable dose for at least 12 weeks without a dose adjustment before screening. Signed written informed consent. Exclusion criteria: At the time of screening, age <18 years or < legal age of majority, whichever is greater. Body Mass Index (BMI) ≤20 or >45 kilograms per meter square (kg/m^2) at Screening. Hemoglobin A1c (HbA1c) <7% or HbA1c >10% via central lab test at screening. Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization. Women of childbearing potential with no effective contraceptive method. Treated with an antidiabetic pharmacological regimen other than a Sulfonylurea at a stable dose with or without Metformin within 12 weeks preceding the screening visit. Previous insulin use >1 month (at any time, aside from treatment of gestational diabetes). History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit. History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit. History of severe hypoglycemia within 6 months prior to the Screening visit. Systolic blood pressure (SBP) >180 millimeter per mercury (mmHg) or diastolic blood pressure (DBP) >100 mmHg or history of hypertensive emergency. 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). 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. Pregnancy, breastfeeding. Participants is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the participant's diary as required per protocol. 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

Organizational Affiliation

Lexicon Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 8403003

City

Litchfield Park

State/Province

Arizona

ZIP/Postal Code

85340

Country

United States

Facility Name

Investigational Site Number 8403018

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Investigational Site Number 8403009

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Investigational Site Number 8403012

City

Huntington Park

State/Province

California

ZIP/Postal Code

90255

Country

United States

Facility Name

Investigational Site Number 8403019

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigational Site Number 8403034

City

Montclair

State/Province

California

ZIP/Postal Code

91763

Country

United States

Facility Name

Investigational Site Number 8403016

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Investigational Site Number 8403014

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Investigational Site Number 8403001

City

Northglenn

State/Province

Colorado

ZIP/Postal Code

80234

Country

United States

Facility Name

Investigational Site Number 8403029

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34201

Country

United States

Facility Name

Investigational Site Number 8403004

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Investigational Site Number 8403020

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33162

Country

United States

Facility Name

Investigational Site Number 8403026

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Investigational Site Number 8403032

City

Orlando

State/Province

Florida

ZIP/Postal Code

32810

Country

United States

Facility Name

Investigational Site Number 8403008

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Investigational Site Number 8403006

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026

Country

United States

Facility Name

Investigational Site Number 8403013

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Investigational Site Number 8403007

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83686

Country

United States

Facility Name

Investigational Site Number 8403011

City

Flint

State/Province

Michigan

ZIP/Postal Code

48532

Country

United States

Facility Name

Investigational Site Number 8403025

City

Richfield

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Investigational Site Number 8403021

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

Investigational Site Number 8403028

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Investigational Site Number 8403015

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Investigational Site Number 8403033

City

Hatboro

State/Province

Pennsylvania

ZIP/Postal Code

19040

Country

United States

Facility Name

Investigational Site Number 8403030

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

Investigational Site Number 8403002

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 8403022

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Investigational Site Number 8403005

City

Burke

State/Province

Virginia

ZIP/Postal Code

22015

Country

United States

Facility Name

Investigational Site Number 1003003

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Investigational Site Number 1003002

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Investigational Site Number 1003004

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Investigational Site Number 2333003

City

Parnu

ZIP/Postal Code

8001

Country

Estonia

Facility Name

Investigational Site Number 3483001

City

Balatonfüred

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Investigational Site Number 3483007

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Investigational Site Number 3483008

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 3483010

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 3483004

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Investigational Site Number 3483006

City

Budapest

ZIP/Postal Code

1213

Country

Hungary

Facility Name

Investigational Site Number 3483011

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Investigational Site Number 3483009

City

Hatvan

ZIP/Postal Code

3000

Country

Hungary

Facility Name

Investigational Site Number 3483005

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Investigational Site Number 3483003

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

Investigational Site Number 3483012

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Investigational Site Number 4103001

City

Goyang-Si, Gyeonggi-Do

ZIP/Postal Code

10380

Country

Korea, Republic of

Facility Name

Investigational Site Number 4103011

City

Guri-Si, Gyeonggi-Do

ZIP/Postal Code

11923

Country

Korea, Republic of

Facility Name

Investigational Site Number 4103003

City

Seongnam-Si, Gyeonggi-Do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Investigational Site Number 4103007

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Investigational Site Number 4103006

City

Seoul

ZIP/Postal Code

1830

Country

Korea, Republic of

Facility Name

Investigational Site Number 4103010

City

Seoul

ZIP/Postal Code

3722

Country

Korea, Republic of

Facility Name

Investigational Site Number 4103005

City

Seoul

ZIP/Postal Code

7345

Country

Korea, Republic of

Facility Name

Investigational Site Number 4103009

City

Wonju-Si, Gangwon-Do

ZIP/Postal Code

26426

Country

Korea, Republic of

Facility Name

Investigational Site Number 6163005

City

Gdansk

ZIP/Postal Code

80-382

Country

Poland

Facility Name

Investigational Site Number 6163006

City

Gdynia

ZIP/Postal Code

81-537

Country

Poland

Facility Name

Investigational Site Number 6163003

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Investigational Site Number 6163002

City

Poznan

ZIP/Postal Code

60702

Country

Poland

Facility Name

Investigational Site Number 6163001

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Investigational Site Number 6163004

City

Wroclaw

ZIP/Postal Code

50-381

Country

Poland

Facility Name

Investigational Site Number 6423004

City

Bucuresti

Country

Romania

Facility Name

Investigational Site Number 6423002

City

Iasi

ZIP/Postal Code

700732

Country

Romania

Facility Name

Investigational Site Number 7033006

City

Bratislava

ZIP/Postal Code

831 06

Country

Slovakia

Facility Name

Investigational Site Number 7033001

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

Investigational Site Number 7033002

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

Investigational Site Number 7033004

City

Malacky

ZIP/Postal Code

901 01

Country

Slovakia

Facility Name

Investigational Site Number 7033003

City

Sturovo

ZIP/Postal Code

943 01

Country

Slovakia

Facility Name

Investigational Site Number 7033007

City

Trencin

ZIP/Postal Code

911 01

Country

Slovakia

Facility Name

Investigational Site Number 8043001

City

Kyiv

ZIP/Postal Code

2002

Country

Ukraine

Facility Name

Investigational Site Number 8043003

City

Kyiv

ZIP/Postal Code

3037

Country

Ukraine

Facility Name

Investigational Site Number 8043002

City

Kyiv

ZIP/Postal Code

3049

Country

Ukraine

Facility Name

Investigational Site Number 8263012

City

Birmingham

ZIP/Postal Code

B15 2SQ

Country

United Kingdom

Facility Name

Investigational Site Number 8263009

City

Cardiff

ZIP/Postal Code

CF15 9SS

Country

United Kingdom

Facility Name

Investigational Site Number 8263007

City

Glasgow

ZIP/Postal Code

G20 0SP

Country

United Kingdom

Facility Name

Investigational Site Number 8263008

City

Hexham

ZIP/Postal Code

NE46 1QJ

Country

United Kingdom

Facility Name

Investigational Site Number 8263003

City

Inverness

ZIP/Postal Code

IV2 3JH

Country

United Kingdom

Facility Name

Investigational Site Number 8263014

City

Liverpool

ZIP/Postal Code

L22 0LG

Country

United Kingdom

Facility Name

Investigational Site Number 8263011

City

Manchester

ZIP/Postal Code

M15 6SE

Country

United Kingdom

Facility Name

Investigational Site Number 8263010

City

Reading

ZIP/Postal Code

RG2 0TG

Country

United Kingdom

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 Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

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Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With 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

Learn more about this trial