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

Type 2 Diabetes Mellitus Clinical Trial

— SOTA-BONE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03386344
• Other study ID #: EFC15294
• Secondary ID: 2017-002041-30U1
• Status: Terminated
• Phase: Phase 3
• Start date: February 19, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2021
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 376
• Est. completion date: May 30, 2020
• Est. primary completion date: May 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion criteria :

• 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.

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 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.
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sotagliflozin
Pharmaceutical form: Tablet; Route of administration: Oral
• Placebo
Pharmaceutical form: Tablet; Route of administration: Oral

Locations

Country	Name	City	State
Australia	Investigational Site Number 0369003	Fremantle
Australia	Investigational Site Number 0369002	Merewether
Australia	Investigational Site Number 0369004	Parkville
Canada	Investigational Site Number 1249003	Brampton
Canada	Investigational Site Number 1249008	Etobicoke
Canada	Investigational Site Number 1249005	Pointe-Claire
Canada	Investigational Site Number 1249004	Thornhill
Canada	Investigational Site Number 1249006	Thornhill
Canada	Investigational Site Number 1249007	Vancouver
Canada	Investigational Site Number 1249002	Victoriaville
Korea, Republic of	Investigational Site Number 4109006	Daejeon
Korea, Republic of	Investigational Site Number 4109005	Guri-Si, Gyeonggi-Do
Korea, Republic of	Investigational Site Number 4109003	Gyeonggi-Do
Korea, Republic of	Investigational Site Number 4109001	Seoul
Korea, Republic of	Investigational Site Number 4109004	Seoul
Mexico	Investigational Site Number 4849001	Aguascalientes
Mexico	Investigational Site Number 4849006	Aguascalientes, Aguascalientes
Mexico	Investigational Site Number 4849003	Cuernavaca
Mexico	Investigational Site Number 4849002	Guadalajara Jalisco
Mexico	Investigational Site Number 4849004	Monterrey
Mexico	Investigational Site Number 4849005	Xalapa
New Zealand	Investigational Site Number 5549004	Auckland
New Zealand	Investigational Site Number 5549003	Christchurch
New Zealand	Investigational Site Number 5549001	Rotorua
New Zealand	Investigational Site Number 5549002	Wellington
Russian Federation	Investigational Site Number 6439007	Kemerovo
Russian Federation	Investigational Site Number 6439005	Novosibirsk
Russian Federation	Investigational Site Number 6439002	Saint-Petersburg
Russian Federation	Investigational Site Number 6439003	Saint-Petersburg
Russian Federation	Investigational Site Number 6439001	St. Petersburg
Russian Federation	Investigational Site Number 6439006	Yaroslavl
Taiwan	Investigational Site Number 1589005	Changhua
Taiwan	Investigational Site Number 1589008	New Taipei City
Taiwan	Investigational Site Number 1589006	Taichung
Taiwan	Investigational Site Number 1589007	Taichung
Taiwan	Investigational Site Number 1589001	Tainan
Taiwan	Investigational Site Number 1589002	Tainan
Taiwan	Investigational Site Number 1589003	Taipei
Taiwan	Investigational Site Number 1589004	Taipei
United States	Investigational Site Number 8409015	Albuquerque	New Mexico
United States	Investigational Site Number 8409013	Austin	Texas
United States	Investigational Site Number 8409002	Chapel Hill	North Carolina
United States	Investigational Site Number 8409004	Chattanooga	Tennessee
United States	Investigational Site Number 8409012	Columbus	Georgia
United States	Investigational Site Number 8409003	Dallas	Texas
United States	Investigational Site Number 8409008	Dayton	Ohio
United States	Investigational Site Number 8409009	Escondido	California
United States	Investigational Site Number 8409011	Evansville	Indiana
United States	Investigational Site Number 8409010	Greenbrae	California
United States	Investigational Site Number 8409007	Katy	Texas
United States	Investigational Site Number 8409005	Walnut Creek	California
United States	Investigational Site Number 8409014	Wichita	Kansas
United States	Investigational Site Number 8409001	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Korea, Republic of,  Mexico,  New Zealand,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26	An analysis of covariance (ANCOVA) model is used for analysis.	Baseline to Week 26
Secondary	Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26	An ANCOVA model is used for analysis.	Baseline to Week 26
Secondary	Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26	An ANCOVA model is used for analysis.	Baseline to Week 26
Secondary	Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26	An ANCOVA model is used for analysis.	Baseline to Week 26
Secondary	Change From Baseline in Body Weight at Week 26	An ANCOVA model is used for analysis.	Baseline to Week 26
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	An ANCOVA model is used for analysis.	Baseline to Week 26
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) at Week 12	An ANCOVA model is used for analysis.	Baseline to Week 12
Secondary	Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26		Week 26
Secondary	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.	up to 106 weeks