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Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin

NCT03351478•Lexicon Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of the study is 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 on a DPP4(i) with or without metformin.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with Type 2 Diabetes on Dipeptidyl peptidase-4 inhibitors(DPP4(i)) with or without metformin at a stable dose for at least 12 weeks prior to Screening Visit. Metformin dose will be ≥1500 mg per day (or maximum tolerated dose \[documented\]). DPP4(i) dose must be the appropriate dose as per local label.
•Signed written informed consent.

Exclusion Criteria

•Body mass index (BMI) ≤20 kg/m\^2 or \>45 kg/m\^2 at Screening.
•Use of any antidiabetic drug other than DPP4 inhibitors and metformin within 12 weeks preceding the Screening Visit.
•Participants who have previously participated in any clinical trial of sotagliflozin/LX4211.
•Use of a selective sodium-glucose co-transporter type 2 (SGLT2) inhibitor (e.g., canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to the screening visit.
•Participants with severe anemia, severe cardiovascular disease (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or participants with a short life expectancy that, according to Investigator, will preclude their safe participation in this study, or will make the implementation of the protocol or interpretation of the study results difficult.
•Current diagnosis of chronic hepatitis and/or other clinically active liver disease requiring treatment.
•Participants with contraindication to empagliflozin as per local labelling.
•Participants with contraindication to metformin as per local labelling.
•Hemoglobin A1c \<7.0% or \>11.0% at Screening (central laboratory).
•Fasting plasma glucose \>270 mg/dL (\>15.0 mmol/L) measured by the central laboratory at Screening (Visit 1), and confirmed by a repeat test (\>270 mg/dL \[\>15.0 mmol/L\]) before Randomization.
+15 more criteria

Locations (160)

Investigational Site Number 8408035

Birmingham, Alabama, United States

Investigational Site Number 8408028

Sheffield, Alabama, United States

Investigational Site Number 8408047

Hawaiian Gardens, California, United States

Investigational Site Number 8408031

Spring Valley, California, United States

Investigational Site Number 8408067

Van Nuys, California, United States

Investigational Site Number 8408069

Northglenn, Colorado, United States

Investigational Site Number 8408009

Miami, Florida, United States

Investigational Site Number 8408049

Ocoee, Florida, United States

Investigational Site Number 8408005

Orlando, Florida, United States

Investigational Site Number 8408040

Orlando, Florida, United States

Key Dates

Start Date

November 27, 2017

Primary Completion Date

May 16, 2019

Completion Date

May 16, 2019

Last Updated

May 11, 2021

Enrollment

770

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Sotagliflozin

DRUG

Empagliflozin

DRUG

Placebo

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

Inclusion Criteria

Exclusion Criteria

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