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Type 2 Diabetes MellitusPhase 3NCT03066830

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

A Phase 3 study testing Sotagliflozin (SAR439954), Metformin and Sulfonylurea in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 76 sites in 10 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 at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin. 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), Metformin and Sulfonylurea
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
507 participants
Where
76 sitesin 10 countries
Study dates
24 Feb 2017to 30 Apr 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 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

76 sites in 10 countries.

76 sites in 10 countries

United States28 sites

  • Investigational Site Number 8403029

    Bradenton, Florida, 34201

  • Investigational Site Number 8403005

    Burke, Virginia, 22015

  • Investigational Site Number 8403002

    Dallas, Texas, 75230

  • Investigational Site Number 8403011

    Flint, Michigan, 48532

  • Investigational Site Number 8403009

    Greenbrae, California, 94904

  • Investigational Site Number 8403028

    Greensboro, North Carolina, 27408

  • Investigational Site Number 8403033

    Hatboro, Pennsylvania, 19040

  • Investigational Site Number 8403021

    Henderson, Nevada, 89014

  • Investigational Site Number 8403022

    Houston, Texas, 77081

  • Investigational Site Number 8403012

    Huntington Park, California, 90255

  • Investigational Site Number 8403030

    Kingsport, Tennessee, 37660

  • Investigational Site Number 8403003

    Litchfield Park, Arizona, 85340

  • Investigational Site Number 8403019

    Los Angeles, California, 90057

  • Investigational Site Number 8403034

    Montclair, California, 91763

  • Investigational Site Number 8403007

    Nampa, Idaho, 83686

  • Investigational Site Number 8403004

    New Port Richey, Florida, 34652

  • Investigational Site Number 8403020

    North Miami Beach, Florida, 33162

  • Investigational Site Number 8403001

    Northglenn, Colorado, 80234

  • Investigational Site Number 8403026

    Ocoee, Florida, 34761

  • Investigational Site Number 8403032

    Orlando, Florida, 32810

  • Investigational Site Number 8403008

    Palm Harbor, Florida, 34684

  • Investigational Site Number 8403006

    Pembroke Pines, Florida, 33026

  • Investigational Site Number 8403018

    Peoria, Arizona, 85381

  • Investigational Site Number 8403013

    Port Charlotte, Florida, 33952

  • Investigational Site Number 8403025

    Richfield, Minnesota, 55432

  • Investigational Site Number 8403015

    Shelby, North Carolina, 28150

  • Investigational Site Number 8403016

    Spring Valley, California, 91978

  • Investigational Site Number 8403014

    Tustin, California, 92780

Other trials in United States

Hungary11 sites

  • Investigational Site Number 3483001

    Balatonfüred, 8230

  • Investigational Site Number 3483007

    Budapest, 1033

  • Investigational Site Number 3483008

    Budapest, 1036

  • Investigational Site Number 3483010

    Budapest, 1036

  • Investigational Site Number 3483004

    Budapest, 1106

  • Investigational Site Number 3483006

    Budapest, 1213

  • Investigational Site Number 3483011

    Gyula, 5700

  • Investigational Site Number 3483009

    Hatvan, 3000

  • Investigational Site Number 3483005

    Kecskemét, 6000

  • Investigational Site Number 3483003

    Pécs, 7623

  • Investigational Site Number 3483012

    Zalaegerszeg, 8900

Other trials in Hungary

South Korea8 sites

  • Investigational Site Number 4103001

    Goyang-Si, Gyeonggi-Do, 10380

  • Investigational Site Number 4103011

    Guri-Si, Gyeonggi-Do, 11923

  • Investigational Site Number 4103003

    Seongnam-Si, Gyeonggi-Do, 13620

  • Investigational Site Number 4103007

    Seoul, 06591

  • Investigational Site Number 4103006

    Seoul, 1830

  • Investigational Site Number 4103010

    Seoul, 3722

  • Investigational Site Number 4103005

    Seoul, 7345

  • Investigational Site Number 4103009

    Wonju-Si, Gangwon-Do, 26426

Other trials in South Korea

United Kingdom8 sites

  • Investigational Site Number 8263012

    Birmingham, B15 2SQ

  • Investigational Site Number 8263009

    Cardiff, CF15 9SS

  • Investigational Site Number 8263007

    Glasgow, G20 0SP

  • Investigational Site Number 8263008

    Hexham, NE46 1QJ

  • Investigational Site Number 8263003

    Inverness, IV2 3JH

  • Investigational Site Number 8263014

    Liverpool, L22 0LG

  • Investigational Site Number 8263011

    Manchester, M15 6SE

  • Investigational Site Number 8263010

    Reading, RG2 0TG

Other trials in United Kingdom

Poland6 sites

  • Investigational Site Number 6163005

    Gdansk, 80-382

  • Investigational Site Number 6163006

    Gdynia, 81-537

  • Investigational Site Number 6163003

    Katowice, 40-040

  • Investigational Site Number 6163002

    Poznan, 60702

  • Investigational Site Number 6163001

    Warsaw, 01-192

  • Investigational Site Number 6163004

    Wroclaw, 50-381

Other trials in Poland

Slovakia6 sites

  • Investigational Site Number 7033006

    Bratislava, 831 06

  • Investigational Site Number 7033001

    Bratislava, 851 01

  • Investigational Site Number 7033002

    Bratislava, 851 01

  • Investigational Site Number 7033004

    Malacky, 901 01

  • Investigational Site Number 7033003

    Štúrovo, 943 01

  • Investigational Site Number 7033007

    Trenčín, 911 01

Other trials in Slovakia

Bulgaria3 sites

  • Investigational Site Number 1003003

    Plovdiv, 4002

  • Investigational Site Number 1003002

    Rousse, 7002

  • Investigational Site Number 1003004

    Sofia, 1784

Other trials in Bulgaria

Ukraine3 sites

  • Investigational Site Number 8043001

    Kyiv, 2002

  • Investigational Site Number 8043003

    Kyiv, 3037

  • Investigational Site Number 8043002

    Kyiv, 3049

Other trials in Ukraine

Romania2 sites

  • Investigational Site Number 6423004

    Bucharest

  • Investigational Site Number 6423002

    Iași, 700732

Other trials in Romania

Estonia1 site

  • Investigational Site Number 2333003

    Pärnu, 8001

Other trials in Estonia

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 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

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.

Read more

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.
Read the 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.

Being tested
Sotagliflozin (SAR439954), Placebo, Metformin, Sulfonylurea
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

  • SulfonylureaDrug

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT03066830
Study groupRoleWhat they receive
Sotagliflozin 400 mgExperimentalFollowing 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.
Receives: Drug: Sotagliflozin (SAR439954)
PlaceboPlacebo comparatorFollowing 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.
Receives: Drug: Placebo; Drug: Metformin; Drug: Sulfonylurea

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

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

    Measured: Baseline to Week 26

Secondary outcomes (6)

  1. 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.

    Measured: Baseline to Week 26

  2. 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.

    Measured: Baseline to Week 12

  3. 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.

    Measured: Baseline to Week 12

  4. 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.

    Measured: Baseline to Week 26

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

    Measured: Week 26

  6. 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 posted28 Feb 2017
  2. Study start24 Feb 2017
  3. Primary completion17 Apr 2019
  4. Study completion30 Apr 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
507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03066830
Sponsor's protocol ID
EFC14835
Other IDs
2016-002826-35, U1111-1186-2612, 2016
Status last verified
Apr 2021
First submitted
24 Feb 2017
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 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin (SAR439954), Metformin and Sulfonylurea in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 76 sites in 10 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 17 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 76 sites in United States, Hungary, South Korea, United Kingdom, Poland and 5 more countries. 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 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 NCT03066830.

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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