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

Last updated: June 3, 2021
Sponsor: Lexicon Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT03386344
EFC15294
U1111-1195-6371
2017-002041-30
  • Ages > 55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria :

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

Exclusion

Exclusion criteria:

  • 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 thatexceeds 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 orthiazolidinedione within 24 months.
  • Bone mineral density (BMD) T- score <-2.0 at any site (ie, lumbar spine, total hip, orfemoral 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 fractureswithin 36 months (eg, bisphosphonates, selective estrogen receptor modulators,calcitonin, teriparatide, denosumab, strontium ranelate, growth hormone, aromataseinhibitors, androgen deprivation therapy, carbamazepine, phenytoin, andphenobarbital). Use of hormonal replacement that includes systemic or transdermalestrogen or testosterone is excluded unless is stable for at least 24 months prior toScreening.
  • Lower extremity complications (such as skin ulcers, infection, osteomyelitis andgangrene) identified during the Screening period, and still requiring treatment atrandomization.
  • Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, suchas heart failure, active cancer, or other conditions that the Investigator believeswith result in a short life expectancy.
  • Renal disease as defined by an estimated glomerular filtration rate (eGFR) <30milliliter per minute (mL/min)/1.73 meter square (m^2) at the Screening Visit by the 4variable Modification of Diet in Renal Disease equation. The above information is not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.

Study Design

Total Participants: 376
Study Start date:
February 19, 2018
Estimated Completion Date:
May 30, 2020

Study 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.

Connect with a study center

  • Investigational Site Number 0369003

    Fremantle, 6160
    Australia

    Site Not Available

  • Investigational Site Number 0369001

    Keswick, 5035
    Australia

    Site Not Available

  • Investigational Site Number 0369002

    Merewether, 2291
    Australia

    Site Not Available

  • Investigational Site Number 0369004

    Parkville, 3050
    Australia

    Site Not Available

  • Investigational Site Number 1249003

    Brampton, L6S 0C6
    Canada

    Site Not Available

  • Investigational Site Number 1249008

    Etobicoke, M9R 4E1
    Canada

    Site Not Available

  • Investigational Site Number 1249005

    Pointe-Claire, H9R 4S3
    Canada

    Site Not Available

  • Investigational Site Number 1249004

    Thornhill, L4J 8L7
    Canada

    Site Not Available

  • Investigational Site Number 1249006

    Thornhill, L4J 1W3
    Canada

    Site Not Available

  • Investigational Site Number 1249007

    Vancouver, V5Y 3W2
    Canada

    Site Not Available

  • Investigational Site Number 1249002

    Victoriaville, G6P 6P6
    Canada

    Site Not Available

  • Investigational Site Number 4109006

    Daejeon, 35233
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4109005

    Guri-Si, Gyeonggi-Do, 11923
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4109003

    Gyeonggi-Do, 13620
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4109001

    Seoul, 1830
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4109004

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4849001

    Aguascalientes, 20129
    Mexico

    Site Not Available

  • Investigational Site Number 4849006

    Aguascalientes, Aguascalientes, 20230
    Mexico

    Site Not Available

  • Investigational Site Number 4849003

    Cuernavaca, 62250
    Mexico

    Site Not Available

  • Investigational Site Number 4849002

    Guadalajara Jalisco, 44130
    Mexico

    Site Not Available

  • Investigational Site Number 4849004

    Monterrey, 64460
    Mexico

    Site Not Available

  • Investigational Site Number 4849005

    Xalapa, 91020
    Mexico

    Site Not Available

  • Investigational Site Number 5549004

    Auckland, 1309
    New Zealand

    Site Not Available

  • Investigational Site Number 5549003

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Investigational Site Number 5549001

    Rotorua, 3010
    New Zealand

    Site Not Available

  • Investigational Site Number 5549002

    Wellington, 6021
    New Zealand

    Site Not Available

  • Investigational Site Number 6439007

    Kemerovo, 650002
    Russian Federation

    Site Not Available

  • Investigational Site Number 6439006

    Moscow,
    Russian Federation

    Site Not Available

  • Investigational Site Number 6439005

    Novosibirsk, 630091
    Russian Federation

    Site Not Available

  • Investigational Site Number 6439002

    Saint-Petersburg, 195213
    Russian Federation

    Site Not Available

  • Investigational Site Number 6439003

    Saint-Petersburg, 196601
    Russian Federation

    Site Not Available

  • Investigational Site Number 6439001

    St. Petersburg, 194358
    Russian Federation

    Site Not Available

  • Investigational Site Number 6439006

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Investigational Site Number 1589005

    Changhua, 500
    Taiwan

    Site Not Available

  • Investigational Site Number 1589008

    New Taipei City, 220
    Taiwan

    Site Not Available

  • Investigational Site Number 1589006

    Taichung, 402
    Taiwan

    Site Not Available

  • Investigational Site Number 1589007

    Taichung, 43303
    Taiwan

    Site Not Available

  • Investigational Site Number 1589001

    Tainan, 710
    Taiwan

    Site Not Available

  • Investigational Site Number 1589002

    Tainan,
    Taiwan

    Site Not Available

  • Investigational Site Number 1589003

    Taipei, 11217
    Taiwan

    Site Not Available

  • Investigational Site Number 1589004

    Taipei, 100
    Taiwan

    Site Not Available

  • Investigational Site Number 1589001

    Taiwan,
    Taiwan

    Site Not Available

  • Investigational Site Number 8409009

    Escondido, California 92025
    United States

    Site Not Available

  • Investigational Site Number 8409010

    Greenbrae, California 94904
    United States

    Site Not Available

  • Investigational Site Number 8409005

    Pleasanton, California 94588
    United States

    Site Not Available

  • Investigational Site Number 8409005

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Investigational Site Number 8409012

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Investigational Site Number 8409011

    Evansville, Indiana 47714-8011
    United States

    Site Not Available

  • Investigational Site Number 8409014

    Wichita, Kansas 67205-1138
    United States

    Site Not Available

  • Investigational Site Number 8409008

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • Investigational Site Number 8409015

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Investigational Site Number 8409002

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Investigational Site Number 8409001

    Wilmington, North Carolina 28401-6638
    United States

    Site Not Available

  • Investigational Site Number 8409008

    Dayton, Ohio 45419-4336
    United States

    Site Not Available

  • Investigational Site Number 8409004

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Investigational Site Number 8409013

    Austin, Texas 78749
    United States

    Site Not Available

  • Investigational Site Number 8409003

    Dallas, Texas 75230
    United States

    Site Not Available

  • Investigational Site Number 8409007

    Houston, Texas 77055
    United States

    Site Not Available

  • Investigational Site Number 8409007

    Katy, Texas 77450
    United States

    Site Not Available

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