Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Treatment
N/AClinical Study ID
Ages > 55 All Genders
Study Summary
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
Study Description
Connect with a study center
Investigational Site Number 0369003
Fremantle, 6160
AustraliaSite Not Available
Investigational Site Number 0369001
Keswick, 5035
AustraliaSite Not Available
Investigational Site Number 0369002
Merewether, 2291
AustraliaSite Not Available
Investigational Site Number 0369004
Parkville, 3050
AustraliaSite Not Available
Investigational Site Number 1249003
Brampton, L6S 0C6
CanadaSite Not Available
Investigational Site Number 1249008
Etobicoke, M9R 4E1
CanadaSite Not Available
Investigational Site Number 1249005
Pointe-Claire, H9R 4S3
CanadaSite Not Available
Investigational Site Number 1249004
Thornhill, L4J 8L7
CanadaSite Not Available
Investigational Site Number 1249006
Thornhill, L4J 1W3
CanadaSite Not Available
Investigational Site Number 1249007
Vancouver, V5Y 3W2
CanadaSite Not Available
Investigational Site Number 1249002
Victoriaville, G6P 6P6
CanadaSite Not Available
Investigational Site Number 4109006
Daejeon, 35233
Korea, Republic ofSite Not Available
Investigational Site Number 4109005
Guri-Si, Gyeonggi-Do, 11923
Korea, Republic ofSite Not Available
Investigational Site Number 4109003
Gyeonggi-Do, 13620
Korea, Republic ofSite Not Available
Investigational Site Number 4109001
Seoul, 1830
Korea, Republic ofSite Not Available
Investigational Site Number 4109004
Seoul, 03722
Korea, Republic ofSite Not Available
Investigational Site Number 4849001
Aguascalientes, 20129
MexicoSite Not Available
Investigational Site Number 4849006
Aguascalientes, Aguascalientes, 20230
MexicoSite Not Available
Investigational Site Number 4849003
Cuernavaca, 62250
MexicoSite Not Available
Investigational Site Number 4849002
Guadalajara Jalisco, 44130
MexicoSite Not Available
Investigational Site Number 4849004
Monterrey, 64460
MexicoSite Not Available
Investigational Site Number 4849005
Xalapa, 91020
MexicoSite Not Available
Investigational Site Number 5549004
Auckland, 1309
New ZealandSite Not Available
Investigational Site Number 5549003
Christchurch, 8011
New ZealandSite Not Available
Investigational Site Number 5549001
Rotorua, 3010
New ZealandSite Not Available
Investigational Site Number 5549002
Wellington, 6021
New ZealandSite Not Available
Investigational Site Number 6439007
Kemerovo, 650002
Russian FederationSite Not Available
Investigational Site Number 6439006
Moscow,
Russian FederationSite Not Available
Investigational Site Number 6439005
Novosibirsk, 630091
Russian FederationSite Not Available
Investigational Site Number 6439002
Saint-Petersburg, 195213
Russian FederationSite Not Available
Investigational Site Number 6439003
Saint-Petersburg, 196601
Russian FederationSite Not Available
Investigational Site Number 6439001
St. Petersburg, 194358
Russian FederationSite Not Available
Investigational Site Number 6439006
Yaroslavl, 150003
Russian FederationSite Not Available
Investigational Site Number 1589005
Changhua, 500
TaiwanSite Not Available
Investigational Site Number 1589008
New Taipei City, 220
TaiwanSite Not Available
Investigational Site Number 1589006
Taichung, 402
TaiwanSite Not Available
Investigational Site Number 1589007
Taichung, 43303
TaiwanSite Not Available
Investigational Site Number 1589001
Tainan, 710
TaiwanSite Not Available
Investigational Site Number 1589002
Tainan,
TaiwanSite Not Available
Investigational Site Number 1589003
Taipei, 11217
TaiwanSite Not Available
Investigational Site Number 1589004
Taipei, 100
TaiwanSite Not Available
Investigational Site Number 1589001
Taiwan,
TaiwanSite Not Available
Investigational Site Number 8409009
Escondido, California 92025
United StatesSite Not Available
Investigational Site Number 8409010
Greenbrae, California 94904
United StatesSite Not Available
Investigational Site Number 8409005
Pleasanton, California 94588
United StatesSite Not Available
Investigational Site Number 8409005
Walnut Creek, California 94598
United StatesSite Not Available
Investigational Site Number 8409012
Columbus, Georgia 31904
United StatesSite Not Available
Investigational Site Number 8409011
Evansville, Indiana 47714-8011
United StatesSite Not Available
Investigational Site Number 8409014
Wichita, Kansas 67205-1138
United StatesSite Not Available
Investigational Site Number 8409008
Lutherville, Maryland 21093
United StatesSite Not Available
Investigational Site Number 8409015
Albuquerque, New Mexico 87106
United StatesSite Not Available
Investigational Site Number 8409002
Chapel Hill, North Carolina 27517
United StatesSite Not Available
Investigational Site Number 8409001
Wilmington, North Carolina 28401-6638
United StatesSite Not Available
Investigational Site Number 8409008
Dayton, Ohio 45419-4336
United StatesSite Not Available
Investigational Site Number 8409004
Chattanooga, Tennessee 37404
United StatesSite Not Available
Investigational Site Number 8409013
Austin, Texas 78749
United StatesSite Not Available
Investigational Site Number 8409003
Dallas, Texas 75230
United StatesSite Not Available
Investigational Site Number 8409007
Houston, Texas 77055
United StatesSite Not Available
Investigational Site Number 8409007
Katy, Texas 77450
United StatesSite Not Available
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