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Type 2 Diabetes MellitusPhase 3NCT02926950

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

A Phase 3 study testing Sotagliflozin (SAR439954) and Metformin in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 93 sites in 4 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 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. 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) and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
518 participants
Where
93 sitesin 4 countries
Study dates
Nov 2016to 22 Mar 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 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.

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 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

93 sites in 4 countries.

93 sites in 4 countries

United States67 sites

  • Investigational Site Number 8402068

    Baton Rouge, Louisiana, 70808-4124

  • Investigational Site Number 8402003

    Birmingham, Alabama, 35205

  • Investigational Site Number 8402017

    Birmingham, Alabama, 35294

  • Investigational Site Number 8402009

    Boynton Beach, Florida, 33472

  • Investigational Site Number 8402056

    Canoga Park, California, 91303

  • Investigational Site Number 8402054

    Chicago, Illinois, 60607

  • Investigational Site Number 8402027

    Clinton, Utah, 84015

  • Investigational Site Number 8402030

    Dallas, Texas, 75230

  • Investigational Site Number 8402016

    Daytona Beach, Florida, 32117

  • Investigational Site Number 8402050

    DeSoto, Texas, 75115

  • Investigational Site Number 8402020

    Escondido, California, 92025

  • Investigational Site Number 8402015

    Eugene, Oregon, 97404-3233

  • Investigational Site Number 8402010

    Fort Worth, Texas, 76164

  • Investigational Site Number 8402028

    Gold River, California, 95670

  • Investigational Site Number 8402067

    Greenbrae, California, 94904

  • Investigational Site Number 8402018

    Greensboro, North Carolina, 27401

  • Investigational Site Number 8402006

    Hialeah, Florida, 33012

  • Investigational Site Number 8402035

    Hialeah, Florida, 33012

  • Investigational Site Number 8402044

    Hialeah, Florida, 33012

  • Investigational Site Number 8402040

    Houston, Texas, 77008

  • Investigational Site Number 8402065

    Houston, Texas, 77058

  • Investigational Site Number 8402057

    Houston, Texas, 77079

  • Investigational Site Number 8402025

    Huntington Park, California, 90255

  • Investigational Site Number 8402045

    Jacksonville, Florida, 32256

  • Investigational Site Number 8402051

    La Mirada, California, 90638

  • Investigational Site Number 8402058

    Lansdale, Pennsylvania, 19446-1002

  • Investigational Site Number 8402005

    Las Vegas, Nevada, 89148

  • Investigational Site Number 8402042

    Lemon Grove, California, 91945

  • Investigational Site Number 8402059

    Lexington, Kentucky, 40503

  • Investigational Site Number 8402011

    Lincoln, California, 95648

  • Investigational Site Number 8402014

    Long Beach, California, 90807

  • Investigational Site Number 8402066

    Long Beach, California, 90807

  • Investigational Site Number 8402029

    Los Angeles, California, 90022

  • Investigational Site Number 8402041

    Los Angeles, California, 90036

  • Investigational Site Number 8402001

    Los Angeles, California, 90057

  • Investigational Site Number 8402008

    Macon, Georgia, 31210

  • Investigational Site Number 8402049

    Magnolia, Texas, 77355

  • Investigational Site Number 8402012

    Metairie, Louisiana, 70006

  • Investigational Site Number 8402026

    Miami, Florida, 33126

  • Investigational Site Number 8402036

    Miami, Florida, 33143

  • Investigational Site Number 8402064

    Miami, Florida, 33183

  • Investigational Site Number 8402007

    Miami, Florida, 33185

  • Investigational Site Number 8402061

    Miami, Florida, 33186

  • Investigational Site Number 8402060

    Miami Beach, Florida, 33140-3608

  • Investigational Site Number 8402002

    Morehead City, North Carolina, 28557

  • Investigational Site Number 8402037

    New Orleans, Louisiana, 70119-6302

  • Investigational Site Number 8402053

    New Orleans, Louisiana, 70124

  • Investigational Site Number 8402069

    Newton, Iowa, 50208

  • Investigational Site Number 8402046

    Odessa, Texas, 79761

  • Investigational Site Number 8402019

    Oklahoma City, Oklahoma, 73104

  • Investigational Site Number 8402062

    Omaha, Nebraska, 68114-3755

  • Investigational Site Number 8402033

    Opa-locka, Florida, 33054

  • Investigational Site Number 8402039

    Orlando, Florida, 32825

  • Investigational Site Number 8402052

    Phoenix, Arizona, 85018

  • Investigational Site Number 8402021

    Rockville, Maryland, 20852

  • Investigational Site Number 8402032

    Salt Lake City, Utah, 84107

  • Investigational Site Number 8402013

    San Antonio, Texas, 78218

  • Investigational Site Number 8402004

    San Antonio, Texas, 78229

  • Investigational Site Number 8402043

    San Diego, California, 92103

  • Investigational Site Number 8402031

    San Ramon, California, 94582

  • Investigational Site Number 8402023

    Schertz, Texas, 78154

  • Investigational Site Number 8402034

    Seattle, Washington, 98105

  • Investigational Site Number 8402047

    Tarzana, California, 91356

  • Investigational Site Number 8402024

    Virginia Beach, Virginia, 23454

  • Investigational Site Number 8402022

    West Des Moines, Iowa, 50265

  • Investigational Site Number 8402063

    West Palm Beach, Florida, 33406-5854

  • Investigational Site Number 8402038

    Winter Haven, Florida, 33880

Other trials in United States

Canada14 sites

  • Investigational Site Number 1242014

    Barrie, L4M 7G1

  • Investigational Site Number 1242004

    Brampton, L6S 0C6

  • Investigational Site Number 1242005

    Brampton, L6T 0G1

  • Investigational Site Number 1242001

    Concord, L4K 4M2

  • Investigational Site Number 1242007

    Etobicoke, M9R 4E1

  • Investigational Site Number 1242010

    Lévis, G6W 0M5

  • Investigational Site Number 1242012

    Newmarket, L3Y 5G8

  • Investigational Site Number 1242013

    Oakville, L6M 1M1

  • Investigational Site Number 1242006

    Pointe-Claire, H9R 4S3

  • Investigational Site Number 1242008

    Sherbrooke, J1L 0H8

  • Investigational Site Number 1242015

    Toronto, M3M 3E5

  • Investigational Site Number 1242002

    Toronto, M4G 3E8

  • Investigational Site Number 1242003

    Toronto, M9W 4L6

  • Investigational Site Number 1242011

    Vancouver, V5X 0C4

Other trials in Canada

Hungary6 sites

  • Investigational Site Number 3482002

    Budapest, 1033

  • Investigational Site Number 3482003

    Budapest, 1088

  • Investigational Site Number 3482006

    Budapest, 1213

  • Investigational Site Number 3482004

    Debrecen, 4025

  • Investigational Site Number 3482001

    Esztergom, 2500

  • Investigational Site Number 3482007

    Nyíregyháza, 4400

Other trials in Hungary

Slovakia6 sites

  • Investigational Site Number 7032001

    Bratislava, 851 01

  • Investigational Site Number 7032005

    Bratislava, 851 01

  • Investigational Site Number 7032003

    Malacky, 901 01

  • Investigational Site Number 7032002

    Nitra, 949 11

  • Investigational Site Number 7032004

    Štúrovo, 943 01

  • Investigational Site Number 7032006

    Trenčín, 911 01

Other trials in Slovakia

About this study

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

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.

Read more

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.
Read the 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.

Being tested
Sotagliflozin (SAR439954), Placebo, Metformin
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.

  • MetforminDrug

    Pharmaceutical form: tablet. Route of administration: oral.

Study groups in NCT02926950
Study groupRoleWhat they receive
Sotagliflozin 400 mg + MetforminExperimentalFollowing 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.
Receives: Drug: Sotagliflozin (SAR439954); Drug: Metformin
Placebo + MetforminPlacebo comparatorFollowing 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.
Receives: Drug: Placebo; Drug: Metformin

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

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

    Measured: Baseline and Week 26

Secondary outcomes (7)

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline and Week 26

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline and Week 26

  3. Change From Baseline in Body Weight at Week 26

    An ANCOVA model was used for the analysis.

    Measured: Baseline and Week 26

  4. 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.

    Measured: Baseline and Week 12

  5. Change From Baseline in SBP at Week 12 for All Participants

    An ANCOVA model was used for the analysis.

    Measured: Baseline and Week 12

  6. Percentage of Participants With HbA1c <6.5% at Week 26

    Measured: Week 26

  7. Percentage of Participants With HbA1c <7.0% at Week 26

    Measured: 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 startNov 2016
  3. Primary completion26 Feb 2019
  4. Study completion22 Mar 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
518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02926950
Sponsor's protocol ID
EFC14834
Other IDs
2016-001800-49, U1111-1181-6145, 2016
Status last verified
Apr 2021
First submitted
5 Oct 2016
Last updated
11 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin (SAR439954) and Metformin in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 93 sites in 4 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 21 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Canada, Hungary, Slovakia. 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 11 May 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 (time frame: Baseline and 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 NCT02926950.

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 11 May 2021.

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