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Type 2 Diabetes MellitusPhase 3SOTA-BONENCT03386344

Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

A Phase 3 study testing Sotagliflozin in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 53 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Sotagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
376 participants
Where
53 sitesin 8 countries
Study dates
19 Feb 2018to 30 May 2020
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with T2D managed with diet and exercise only or with a stable antidiabetes regimen (in monotherapy or combination therapy that can include oral antidiabetes medications, insulin, or glucagon-like peptide-1 agonists) for more than 12 weeks.
  • Participants has given written informed consent to participate in the study in accordance with local regulations.

Who cannot join

  • Age <55 years.
  • Women who have been postmenopausal (or undergone bilateral oophorectomy) for less than 5 years.
  • Type 1 diabetes mellitus.
  • Body mass index (BMI) ≤20 or >45 kilogram per meter square kg/m^2 or bodyweight that exceeds the weight limits of the DXA scanner.
  • Hemoglobin A1C (HbA1c) <7.0% or HbA1c >11.0%.
  • Use of a selective sodium-glucose cotransporter type 2 (SGLT2) inhibitor or thiazolidinedione within 24 months.
Show all 13Show fewer
  • Bone mineral density (BMD) T- score <-2.0 at any site (ie, lumbar spine, total hip, or femoral neck).
  • History of fracture within 12 months (except for fractures of the hand/fingers, foot/toes, facial bones, and skull).
  • Treatment with medications known to affect bone mass or modify the risk of fractures within 36 months (eg, bisphosphonates, selective estrogen receptor modulators, calcitonin, teriparatide, denosumab, strontium ranelate, growth hormone, aromatase inhibitors, androgen deprivation therapy, carbamazepine, phenytoin, and phenobarbital). Use of hormonal replacement that includes systemic or transdermal estrogen or testosterone is excluded unless is stable for at least 24 months prior to Screening.
  • Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at randomization.
  • Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy.
  • Renal disease as defined by an estimated glomerular filtration rate (eGFR) <30 milliliter per minute (mL/min)/1.73 meter square (m^2) at the Screening Visit by the 4 variable Modification of Diet in Renal Disease equation.
  • 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

53 sites in 8 countries.

53 sites in 8 countries

United States14 sites

  • Investigational Site Number 8409015

    Albuquerque, New Mexico, 87106

  • Investigational Site Number 8409013

    Austin, Texas, 78749

  • Investigational Site Number 8409002

    Chapel Hill, North Carolina, 27517

  • Investigational Site Number 8409004

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 8409012

    Columbus, Georgia, 31904

  • Investigational Site Number 8409003

    Dallas, Texas, 75230

  • Investigational Site Number 8409008

    Dayton, Ohio, 45419-4336

  • Investigational Site Number 8409009

    Escondido, California, 92025

  • Investigational Site Number 8409011

    Evansville, Indiana, 47714-8011

  • Investigational Site Number 8409010

    Greenbrae, California, 94904

  • Investigational Site Number 8409007

    Katy, Texas, 77450

  • Investigational Site Number 8409005

    Walnut Creek, California, 94598

  • Investigational Site Number 8409014

    Wichita, Kansas, 67205-1138

  • Investigational Site Number 8409001

    Wilmington, North Carolina, 28401-6638

Other trials in United States

Taiwan8 sites

  • Investigational Site Number 1589005

    Changhua, 500

  • Investigational Site Number 1589008

    New Taipei City, 220

  • Investigational Site Number 1589006

    Taichung, 402

  • Investigational Site Number 1589007

    Taichung, 43303

  • Investigational Site Number 1589001

    Tainan, 710

  • Investigational Site Number 1589002

    Tainan

  • Investigational Site Number 1589004

    Taipei, 100

  • Investigational Site Number 1589003

    Taipei, 11217

Other trials in Taiwan

Canada7 sites

  • Investigational Site Number 1249003

    Brampton, L6S 0C6

  • Investigational Site Number 1249008

    Etobicoke, M9R 4E1

  • Investigational Site Number 1249005

    Pointe-Claire, H9R 4S3

  • Investigational Site Number 1249006

    Thornhill, L4J 1W3

  • Investigational Site Number 1249004

    Thornhill, L4J 8L7

  • Investigational Site Number 1249007

    Vancouver, V5Y 3W2

  • Investigational Site Number 1249002

    Victoriaville, G6P 6P6

Other trials in Canada

Mexico6 sites

  • Investigational Site Number 4849001

    Aguascalientes, 20129

  • Investigational Site Number 4849006

    Aguascalientes, Aguascalientes, 20230

  • Investigational Site Number 4849003

    Cuernavaca, 62250

  • Investigational Site Number 4849002

    Guadalajara Jalisco, 44130

  • Investigational Site Number 4849004

    Monterrey, 64460

  • Investigational Site Number 4849005

    Xalapa, 91020

Other trials in Mexico

Russia6 sites

  • Investigational Site Number 6439007

    Kemerovo, 650002

  • Investigational Site Number 6439005

    Novosibirsk, 630091

  • Investigational Site Number 6439001

    Saint Petersburg, 194358

  • Investigational Site Number 6439002

    Saint Petersburg, 195213

  • Investigational Site Number 6439003

    Saint Petersburg, 196601

  • Investigational Site Number 6439006

    Yaroslavl, 150003

Other trials in Russia

South Korea5 sites

  • Investigational Site Number 4109006

    Daejeon, 35233

  • Investigational Site Number 4109005

    Guri-Si, Gyeonggi-Do, 11923

  • Investigational Site Number 4109003

    Gyeonggi-do, 13620

  • Investigational Site Number 4109004

    Seoul, 03722

  • Investigational Site Number 4109001

    Seoul, 1830

Other trials in South Korea

New Zealand4 sites

  • Investigational Site Number 5549004

    Auckland, 1309

  • Investigational Site Number 5549003

    Christchurch, 8011

  • Investigational Site Number 5549001

    Rotorua, 3010

  • Investigational Site Number 5549002

    Wellington, 6021

Other trials in New Zealand

Australia3 sites

  • Investigational Site Number 0369003

    Fremantle, 6160

  • Investigational Site Number 0369002

    Merewether, 2291

  • Investigational Site Number 0369004

    Parkville, 3050

Other trials in Australia

About this study

Official title: A 26-week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study With a 78-week Extension Period to Evaluate the Efficacy and Bone Safety of Sotagliflozin in Patients 55 Years or Older With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.

Read the detailed description

Study duration per participant is approximately 110 weeks (Screening period of up to 2 weeks, 2 week single-blind run-in period), a 26-week double-blind core treatment period, a 78-week double-blind extension period, and a 2- week post treatment follow up period.

Dual-energy X-ray absorptiometry (DXA) scans will be performed to assess Bone Mineral Density and Fat vs. Lean body mass at baseline and Weeks 26, 52, and 104.

Being tested
Sotagliflozin, 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.

  • SotagliflozinDrug

    Also called SAR439954

    Pharmaceutical form: Tablet; Route of administration: Oral

  • PlaceboDrug

    Pharmaceutical form: Tablet; Route of administration: Oral

Study groups in NCT03386344
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFollowing a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, 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 106 weeks.
Receives: Drug: Placebo
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, once daily, before the first meal of the day, 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 104 weeks.
Receives: Drug: Sotagliflozin; Drug: Placebo
Sotagliflozin 400 mgExperimentalFollowing a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, 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 104 weeks.
Receives: Drug: Sotagliflozin

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 is used for analysis.

    Measured: Baseline to Week 26

Secondary outcomes (8)

  1. Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26

    An ANCOVA model is used for analysis.

    Measured: Baseline to Week 26

  2. Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26

    An ANCOVA model is used for analysis.

    Measured: Baseline to Week 26

  3. Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26

    An ANCOVA model is used for analysis.

    Measured: Baseline to Week 26

  4. Change From Baseline in Body Weight at Week 26

    An ANCOVA model is used for analysis.

    Measured: Baseline to Week 26

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

    An ANCOVA model is used for analysis.

    Measured: Baseline to Week 26

  6. Change From Baseline in Systolic Blood Pressure (SBP) at Week 12

    An ANCOVA model is used for analysis.

    Measured: Baseline to Week 12

  7. Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26

    Measured: Week 26

  8. Percentage of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

    Measured: up to 106 weeks

Timeline

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

  1. First posted29 Dec 2017
  2. Study start19 Feb 2018
  3. Primary completion22 May 2019
  4. Study completion30 May 2020

Why it stopped: Study terminated prematurely for financial reasons and Covid-19 pandemic.

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03386344
Sponsor's protocol ID
EFC15294
Other IDs
2017-002041-30, U1111-1195-6371, 2017
Acronym
SOTA-BONE
Status last verified
Jun 2021
First submitted
21 Dec 2017
Last updated
25 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 in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 53 sites in 8 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 13 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: stopped early, as of the sponsor's last update on 25 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 53 sites in United States, Taiwan, Canada, Mexico, Russia and 3 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 25 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 (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 NCT03386344.

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 25 Jun 2021.

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