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Type 2 Diabetes MellitusPhase 3NCT02926937

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

A Phase 3 study testing Sotagliflozin (SAR439954) in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 70 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Sotagliflozin (SAR439954)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
399 participants
Where
70 sitesin 3 countries
Study dates
11 Nov 2016to 17 May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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).
  • 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. Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research.
  • Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.
  • Severe renal disease as defined by estimated glomerular filtration rate (eGFR) of <30 millimeter per minute (mL/min)/1.73 meter square (m^2)² at screening by the 4 variable Modification of Diet in Renal Disease (MDRD) equation.
  • Participant 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.
  • Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.
  • The above information is not intended to contain all considerations relevant to a Participant potential participation in a clinical trial.

Trial locations and contacts

70 sites in 3 countries.

70 sites in 3 countries

United States56 sites

  • Investigational Site Number 8401048

    Akron, Ohio, 44311

  • Investigational Site Number 8401028

    Anaheim, California, 92801

  • Investigational Site Number 8401051

    Anderson, South Carolina, 29621

  • Investigational Site Number 8401033

    Atlanta, Georgia, 30303

  • Investigational Site Number 8401024

    Bradenton, Florida, 34201

  • Investigational Site Number 8401057

    Canoga Park, California, 91303

  • Investigational Site Number 8401032

    Chesapeake, Virginia, 23321-5205

  • Investigational Site Number 8401044

    Chicago, Illinois, 60602

  • Investigational Site Number 8401040

    Clearwater, Florida, 33756

  • Investigational Site Number 8401020

    Corvallis, Oregon, 97330

  • Investigational Site Number 8401014

    Daytona Beach, Florida, 32117

  • Investigational Site Number 8401031

    Denver, Colorado, 80220

  • Investigational Site Number 8401006

    Eugene, Oregon, 97404

  • Investigational Site Number 8401042

    Fayetteville, North Carolina, 28314

  • Investigational Site Number 8401005

    Fort Worth, Texas, 76164

  • Investigational Site Number 8401058

    Garden Grove, California, 92844-2751

  • Investigational Site Number 8401012

    Greensboro, North Carolina, 27401

  • Investigational Site Number 8401002

    Greer, South Carolina, 29651

  • Investigational Site Number 8401029

    Hawaiian Gardens, California, 90716

  • Investigational Site Number 8401007

    Hialeah, Florida, 33012

  • Investigational Site Number 8401046

    Homestead, Florida, 33030

  • Investigational Site Number 8401019

    Houston, Texas, 77081

  • Investigational Site Number 8401050

    Houston, Texas, 77099

  • Investigational Site Number 8401017

    Huntington Park, California, 90255

  • Investigational Site Number 8401037

    Katy, Texas, 77450

  • Investigational Site Number 8401038

    Lake Charles, Louisiana, 70601

  • Investigational Site Number 8401041

    Levittown, Pennsylvania, 19056

  • Investigational Site Number 8401056

    Long Beach, California, 90806

  • Investigational Site Number 8401013

    Long Beach, California, 90807

  • Investigational Site Number 8401063

    Los Angeles, California, 90036

  • Investigational Site Number 8401011

    Los Angeles, California, 90057

  • Investigational Site Number 8401003

    Marion, Ohio, 43302

  • Investigational Site Number 8401043

    McAllen, Texas, 78504

  • Investigational Site Number 8401018

    Miami, Florida, 33135

  • Investigational Site Number 8401008

    Miami, Florida, 33185

  • Investigational Site Number 8401022

    Montclair, California, 91763

  • Investigational Site Number 8401052

    Newton, Iowa, 50208

  • Investigational Site Number 8401059

    North Richland Hills, Texas, 76180

  • Investigational Site Number 8401060

    Northglenn, Colorado, 80234

  • Investigational Site Number 8401039

    Norwalk, California, 90650

  • Investigational Site Number 8401053

    Orlando, Florida, 32825

  • Investigational Site Number 8401062

    Palm Harbor, Florida, 34684

  • Investigational Site Number 8401004

    San Antonio, Texas, 78218

  • Investigational Site Number 8401054

    San Antonio, Texas, 78229

  • Investigational Site Number 8401001

    San Antonio, Texas, 78231

  • Investigational Site Number 8401035

    San Dimas, California, 91713

  • Investigational Site Number 8401055

    Schertz, Texas, 78154

  • Investigational Site Number 8401010

    Suffolk, Virginia, 23435-3763

  • Investigational Site Number 8401023

    Sugar Land, Texas, 77478

  • Investigational Site Number 8401049

    Tucson, Arizona, 85741

  • Investigational Site Number 8401026

    Tucson, Arizona, 85745

  • Investigational Site Number 8401025

    Tustin, California, 92780

  • Investigational Site Number 8401015

    Van Nuys, California, 91405

  • Investigational Site Number 8401016

    West Des Moines, Iowa, 50265

  • Investigational Site Number 8401061

    West Palm Beach, Florida, 33406-5854

  • Investigational Site Number 8401034

    Wichita, Kansas, 67205-1138

Other trials in United States

Mexico10 sites

  • Investigational Site Number 4841006

    Aguascalientes, 20230

  • Investigational Site Number 4841010

    Aguascalientes, 20230

  • Investigational Site Number 4841003

    Cd. México, México, 11410

  • Investigational Site Number 4841004

    Chihuahua City, 31200

  • Investigational Site Number 4841001

    Culiacán, 80230

  • Investigational Site Number 4841005

    Durango, Durango, 34080

  • Investigational Site Number 4841009

    Guadalajara, 44600

  • Investigational Site Number 4841007

    México, 11850

  • Investigational Site Number 4841008

    Monterrey, 64020

  • Investigational Site Number 4841002

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Canada4 sites

  • Investigational Site Number 1241002

    Sherbrooke, J1L 0H8

  • Investigational Site Number 1241005

    Toronto, M3M 3E5

  • Investigational Site Number 1241001

    Toronto, M9W 4L6

  • Investigational Site Number 1241006

    Vancouver, V5X 0C4

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin as Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

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.

Read more

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.
Read the detailed description

Up to 34 weeks, including a Screening Period consisting of a Screening Phase of up to 2 weeks and a 2-week single-blind placebo Run-in Phase, a 26-week double-blind Treatment Period, and a 4-week post-treatment Follow-up visit to collect safety information.

Being tested
Sotagliflozin (SAR439954), Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sotagliflozin (SAR439954)Drug

    Pharmaceutical form: tablet;

    Route of administration: oral

  • PlaceboDrug

    Pharmaceutical form: tablet;

    Route of administration: oral

Study groups in NCT02926937
Study groupRoleWhat they receive
Sotagliflozin 400 mgExperimentalFollowing 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.
Receives: Drug: Sotagliflozin (SAR439954)
Sotagliflozin 200 mgExperimentalFollowing 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.
Receives: Drug: Sotagliflozin (SAR439954); Drug: Placebo
PlaceboPlacebo comparatorFollowing 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 26

Secondary outcomes (11)

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 26

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 26

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 26

  4. 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)

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 12

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 12

  6. Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo)

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 12

  7. Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo)

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 26

  8. Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo)

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 26

  9. Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo)

    Measured: Week 26

  10. Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo)

    Measured: Week 26

  11. Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo)

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study start11 Nov 2016
  3. Primary completion22 Apr 2019
  4. Study completion17 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02926937
Sponsor's protocol ID
EFC14833
Other IDs
2016-001799-31, U1111-1180-6169, 2016
Status last verified
Jun 2021
First submitted
5 Oct 2016
Last updated
21 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin (SAR439954) in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 70 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Mexico, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo) (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02926937.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.

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