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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03386344




Registration number
NCT03386344
Ethics application status
Date submitted
21/12/2017
Date registered
29/12/2017

Titles & IDs
Public title
Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Scientific 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
Secondary ID [1] 0 0
2017-002041-30
Secondary ID [2] 0 0
EFC15294
Universal Trial Number (UTN)
Trial acronym
SOTA-BONE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sotagliflozin
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Following 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.

Experimental: Sotagliflozin 200 mg - Following 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.

Experimental: Sotagliflozin 400 mg - Following 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.


Treatment: Drugs: Sotagliflozin
Pharmaceutical form: Tablet; Route of administration: Oral

Treatment: Drugs: Placebo
Pharmaceutical form: Tablet; Route of administration: Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
Timepoint [1] 0 0
Baseline to Week 26
Secondary outcome [1] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26
Timepoint [1] 0 0
Baseline to Week 26
Secondary outcome [2] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26
Timepoint [2] 0 0
Baseline to Week 26
Secondary outcome [3] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26
Timepoint [3] 0 0
Baseline to Week 26
Secondary outcome [4] 0 0
Change From Baseline in Body Weight at Week 26
Timepoint [4] 0 0
Baseline to Week 26
Secondary outcome [5] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Timepoint [5] 0 0
Baseline to Week 26
Secondary outcome [6] 0 0
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
Timepoint [6] 0 0
Baseline to Week 12
Secondary outcome [7] 0 0
Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26
Timepoint [7] 0 0
Week 26
Secondary outcome [8] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [8] 0 0
up to 106 weeks

Eligibility
Key inclusion criteria
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.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/05/2020
Sample size
Target
Accrual to date
Final
376
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 0369003 - Fremantle
Recruitment hospital [2] 0 0
Investigational Site Number 0369002 - Merewether
Recruitment hospital [3] 0 0
Investigational Site Number 0369004 - Parkville
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
New Mexico
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Brampton
Country [11] 0 0
Canada
State/province [11] 0 0
Etobicoke
Country [12] 0 0
Canada
State/province [12] 0 0
Pointe-Claire
Country [13] 0 0
Canada
State/province [13] 0 0
Thornhill
Country [14] 0 0
Canada
State/province [14] 0 0
Vancouver
Country [15] 0 0
Canada
State/province [15] 0 0
Victoriaville
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Daejeon
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Guri-Si, Gyeonggi-Do
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Gyeonggi-Do
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Mexico
State/province [20] 0 0
Aguascalientes, Aguascalientes
Country [21] 0 0
Mexico
State/province [21] 0 0
Aguascalientes
Country [22] 0 0
Mexico
State/province [22] 0 0
Cuernavaca
Country [23] 0 0
Mexico
State/province [23] 0 0
Guadalajara Jalisco
Country [24] 0 0
Mexico
State/province [24] 0 0
Monterrey
Country [25] 0 0
Mexico
State/province [25] 0 0
Xalapa
Country [26] 0 0
New Zealand
State/province [26] 0 0
Auckland
Country [27] 0 0
New Zealand
State/province [27] 0 0
Christchurch
Country [28] 0 0
New Zealand
State/province [28] 0 0
Rotorua
Country [29] 0 0
New Zealand
State/province [29] 0 0
Wellington
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Kemerovo
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Novosibirsk
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Saint-Petersburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
St. Petersburg
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Yaroslavl
Country [35] 0 0
Taiwan
State/province [35] 0 0
Changhua
Country [36] 0 0
Taiwan
State/province [36] 0 0
New Taipei City
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taichung
Country [38] 0 0
Taiwan
State/province [38] 0 0
Tainan
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lexicon Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suman Wason, MD
Address 0 0
Lexicon Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03386344