Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

NCT02926937 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: EFC148332016-001799-31U1111-1180-6169
• Study Type: interventional
• Target: 399
• Locations: 3 countries
• Sites: 70

Brief Summary

Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise. Secondary Objectives:

• To compare Sotagliflozin 400 mg versus placebo based on:
• 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 per mercury (mmHg).
• Change from baseline in SBP for all participants.
• Change from baseline in body weight.
• Proportion of participants with HbA1c \<6.5%, \<7.0%.
• To compare Sotagliflozin 200 mg versus placebo based on:
• Change from baseline in HbA1c.
• Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
• Change from baseline in body weight.
• Change from baseline in SBP for all participants.
• To evaluate the safety of Sotagliflozin 400 and 200 mg versus placebo.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo)

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

  Baseline to Week 26

Secondary Outcomes (11)

• Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo)

  Baseline to Week 26

• Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo)

  Baseline to Week 26

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo)

  Baseline to Week 26

• Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo)

  Baseline to Week 12

• Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo)

  Baseline to Week 12

Other Outcomes (2)

• Percentage of Participants With Hypoglycemic Events (Sotagliflozin 400 mg Versus Placebo)

  Week 26

• Percentage of Participants With Hypoglycemic Events (Sotagliflozin 200 mg Versus Placebo)

  Week 26

Study Arms (3)

Sotagliflozin 400 mg

EXPERIMENTAL

Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 milligrams (mg) administered as two 200 mg tablets, once daily (QD), before the first meal of the day in the double-blind treatment period for up to 26 weeks.

Drug: Sotagliflozin (SAR439954)

Sotagliflozin 200 mg

EXPERIMENTAL

Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 Sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.

Drug: Sotagliflozin (SAR439954); Drug: Placebo

Placebo

PLACEBO COMPARATOR

Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.

Drug: Placebo

Interventions

Sotagliflozin (SAR439954) DRUG

Pharmaceutical form: tablet; Route of administration: oral

Sotagliflozin 200 mg; Sotagliflozin 400 mg

Placebo DRUG

Pharmaceutical form: tablet; Route of administration: oral

Placebo; Sotagliflozin 200 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants (male and female) with T2D, who are treated with diet and exercise only during the 12 weeks prior to screening.
• Signed written informed consent.

You may not qualify if:

• Age \<18 years at Screening or \< legal age of majority, whichever is greater.
• Type 1 diabetes mellitus.
• Body Mass Index (BMI) ≤20 or \>45 kilogram per meter square (kg/m\^2) at Screening.
• Hemoglobin A1c (HbA1c) \<7% or \>10% via central laboratory test at Screening.
• Fasting plasma glucose (FPG) \>15 millimole 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.
• Women of childbearing potential not willing to use highly effective contraceptive 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 during the study.
• Treated with an antidiabetic pharmacological agent within the 12 weeks prior to the Screening Visit.
• Previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes).
• History of 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 millimeter of mercury (mmHg) (systolic) or \>100 mmHg (diastolic).
• History of hypertensive 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 that, according to the 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.
• Total bilirubin: \>1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome).

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (70)

Investigational Site Number 8401049

Tucson, Arizona, 85741, United States

Location

Investigational Site Number 8401026

Tucson, Arizona, 85745, United States

Location

Investigational Site Number 8401028

Anaheim, California, 92801, United States

Location

Investigational Site Number 8401057

Canoga Park, California, 91303, United States

Location

Investigational Site Number 8401058

Garden Grove, California, 92844-2751, United States

Location

Investigational Site Number 8401029

Hawaiian Gardens, California, 90716, United States

Location

Investigational Site Number 8401017

Huntington Park, California, 90255, United States

Location

Investigational Site Number 8401056

Long Beach, California, 90806, United States

Location

Investigational Site Number 8401013

Long Beach, California, 90807, United States

Location

Investigational Site Number 8401063

Los Angeles, California, 90036, United States

Location

Investigational Site Number 8401011

Los Angeles, California, 90057, United States

Location

Investigational Site Number 8401022

Montclair, California, 91763, United States

Location

Investigational Site Number 8401039

Norwalk, California, 90650, United States

Location

Investigational Site Number 8401035

San Dimas, California, 91713, United States

Location

Investigational Site Number 8401025

Tustin, California, 92780, United States

Location

Investigational Site Number 8401015

Van Nuys, California, 91405, United States

Location

Investigational Site Number 8401031

Denver, Colorado, 80220, United States

Location

Investigational Site Number 8401060

Northglenn, Colorado, 80234, United States

Location

Investigational Site Number 8401024

Bradenton, Florida, 34201, United States

Location

Investigational Site Number 8401040

Clearwater, Florida, 33756, United States

Location

Investigational Site Number 8401014

Daytona Beach, Florida, 32117, United States

Location

Investigational Site Number 8401007

Hialeah, Florida, 33012, United States

Location

Investigational Site Number 8401046

Homestead, Florida, 33030, United States

Location

Investigational Site Number 8401018

Miami, Florida, 33135, United States

Location

Investigational Site Number 8401008

Miami, Florida, 33185, United States

Location

Investigational Site Number 8401053

Orlando, Florida, 32825, United States

Location

Investigational Site Number 8401062

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 8401061

West Palm Beach, Florida, 33406-5854, United States

Location

Investigational Site Number 8401033

Atlanta, Georgia, 30303, United States

Location

Investigational Site Number 8401044

Chicago, Illinois, 60602, United States

Location

Investigational Site Number 8401052

Newton, Iowa, 50208, United States

Location

Investigational Site Number 8401016

West Des Moines, Iowa, 50265, United States

Location

Investigational Site Number 8401034

Wichita, Kansas, 67205-1138, United States

Location

Investigational Site Number 8401038

Lake Charles, Louisiana, 70601, United States

Location

Investigational Site Number 8401042

Fayetteville, North Carolina, 28314, United States

Location

Investigational Site Number 8401012

Greensboro, North Carolina, 27401, United States

Location

Investigational Site Number 8401048

Akron, Ohio, 44311, United States

Location

Investigational Site Number 8401003

Marion, Ohio, 43302, United States

Location

Investigational Site Number 8401020

Corvallis, Oregon, 97330, United States

Location

Investigational Site Number 8401006

Eugene, Oregon, 97404, United States

Location

Investigational Site Number 8401041

Levittown, Pennsylvania, 19056, United States

Location

Investigational Site Number 8401051

Anderson, South Carolina, 29621, United States

Location

Investigational Site Number 8401002

Greer, South Carolina, 29651, United States

Location

Investigational Site Number 8401005

Fort Worth, Texas, 76164, United States

Location

Investigational Site Number 8401019

Houston, Texas, 77081, United States

Location

Investigational Site Number 8401050

Houston, Texas, 77099, United States

Location

Investigational Site Number 8401037

Katy, Texas, 77450, United States

Location

Investigational Site Number 8401043

McAllen, Texas, 78504, United States

Location

Investigational Site Number 8401059

North Richland Hills, Texas, 76180, United States

Location

Investigational Site Number 8401004

San Antonio, Texas, 78218, United States

Location

Investigational Site Number 8401054

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 8401001

San Antonio, Texas, 78231, United States

Location

Investigational Site Number 8401055

Schertz, Texas, 78154, United States

Location

Investigational Site Number 8401023

Sugar Land, Texas, 77478, United States

Location

Investigational Site Number 8401032

Chesapeake, Virginia, 23321-5205, United States

Location

Investigational Site Number 8401010

Suffolk, Virginia, 23435-3763, United States

Location

Investigational Site Number 1241002

Sherbrooke, J1L 0H8, Canada

Location

Investigational Site Number 1241005

Toronto, M3M 3E5, Canada

Location

Investigational Site Number 1241001

Toronto, M9W 4L6, Canada

Location

Investigational Site Number 1241006

Vancouver, V5X 0C4, Canada

Location

Investigational Site Number 4841006

Aguascalientes, 20230, Mexico

Location

Investigational Site Number 4841010

Aguascalientes, 20230, Mexico

Location

Investigational Site Number 4841003

Cd. México, México, 11410, Mexico

Location

Investigational Site Number 4841004

Chihuahua City, 31200, Mexico

Location

Investigational Site Number 4841001

Culiacán, 80230, Mexico

Location

Investigational Site Number 4841005

Durango, Durango, 34080, Mexico

Location

Investigational Site Number 4841009

Guadalajara, 44600, Mexico

Location

Investigational Site Number 4841007

México, 11850, Mexico

Location

Investigational Site Number 4841008

Monterrey, 64020, Mexico

Location

Investigational Site Number 4841002

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Affairs
• Organization: Lexicon Pharmaceuticals, Inc,

medical-information@lexpharma.com

338-6064

Study Officials

• Suman Wason, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 6, 2016
• Study Start: November 11, 2016
• Primary Completion: April 22, 2019
• Study Completion: May 17, 2019
• Last Updated: June 21, 2021
• Results First Posted: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); ME (10); US (56)