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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03386344
Ethics application status
Date submitted
21/12/2017
Date registered
21/12/2017
Date last updated
12/12/2018

Titles & IDs
Public title
Efficacy and Bone Safety of Sotagliflozin Dose 1 and Dose 2 Versus Placebo in Subjects 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 (SAR439954)
Treatment: Drugs - Placebo

Experimental: Dose 1 - Sotagliflozin dose 1 given as two (2) dose 2 sotagliflozin tablets on top of baseline antidiabetic therapy

Experimental: Dose 2 - Sotagliflozin dose 2 given as one (1) dose 2 sotagliflozin tablet and one (1) sotagliflozin matching placebo tablet on top of baseline antidiabetic therapy

Placebo Comparator: Placebo - Placebo, given as two (2) sotagliflozin matching placebo tablets on top of baseline antidiabetic therapy


Treatment: Drugs: Sotagliflozin (SAR439954)
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 in Hemoglobin A1C (HbA1c) - Absolute change from baseline to Week 26 HbA1c (for sotagliflozin dose 1)
Timepoint [1] 0 0
Baseline to Week 26
Secondary outcome [1] 0 0
Change in HbA1c - Absolute change from Baseline to Week 26 in HbA1c comparing sotagliflozin dose 2 versus placebo
Timepoint [1] 0 0
Baseline to Week 26
Secondary outcome [2] 0 0
Change in body weight (BW) - Absolute change from Baseline to Week 26 in BW (doses 1 and 2)
Timepoint [2] 0 0
Baseline to Week 26
Secondary outcome [3] 0 0
Change in Fasting Plasma Glucose (FPG) - Absolute change from Baseline to Week 26 in FPG (doses 1 and 2)
Timepoint [3] 0 0
Baseline to Week 26
Secondary outcome [4] 0 0
Change in systolic blood pressure (SBP) - Absolute change from Baseline to Week 12 in SBP in all patients (dose 1 and dose 2)
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
Patients with HbA1c < 7.0% - Percentage of patients with HbA1c < 7.0% at Week 26 (doses 1 and 2)
Timepoint [5] 0 0
At Week 26
Secondary outcome [6] 0 0
Percent change in bone mineral density (BMD) of lumbar spine - Percent change in BMD of lumbar spine at week 26 (doses 1 and 2)
Timepoint [6] 0 0
Baseline to Week 26
Secondary outcome [7] 0 0
Percent change in BMD of total hip - Percent change in BMD of total hip at week 26 (doses 1 and 2)
Timepoint [7] 0 0
Baseline to Week 26
Secondary outcome [8] 0 0
Percent change in BMD of femoral neck - Percent change in BMD of femoral neck at week 26 (doses 1 and 2)
Timepoint [8] 0 0
Baseline to Week 26
Secondary outcome [9] 0 0
Adverse events - Absolute number of patients with adverse events up to week 104 (doses 1 and 2)
Timepoint [9] 0 0
Up to 104 weeks

Eligibility
Key inclusion criteria
Inclusion criteria :

- Patients with Type 2 Diabetes (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.

- Patient has given written informed consent to participate in the study in accordance
with local regulations.
Minimum age
55 Years
Maximum age
No limit
Gender
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 kg/m2 or body weight that exceeds the weight limits
of the Dual-energy X-ray absorptiometry (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
mL/min/1.73m² 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 patient'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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 0369003 - Fremantle
Recruitment hospital [2] 0 0
Investigational Site Number 0369001 - Keswick
Recruitment hospital [3] 0 0
Investigational Site Number 0369002 - Merewether
Recruitment hospital [4] 0 0
Investigational Site Number 0369004 - Parkville
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment postcode(s) [2] 0 0
5035 - Keswick
Recruitment postcode(s) [3] 0 0
2291 - Merewether
Recruitment postcode(s) [4] 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
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to
hemoglobin A1c (Hb1Ac) reduction in patients with type 2 diabetes (T2D) who have inadequate
glycemic control on diet and exercise only or with a stable antidiabetes regimen.

Secondary Objectives:

- To compare the effects of sotagliflozin dose 1 and dose 2 versus placebo with respect to
the percent change in bone mineral density (BMD) at lumbar spine, total hip, and femoral
neck, measured by dual-energy X-ray absorptiometry (DXA).

- To demonstrate the superiority of sotagliflozin dose 1 versus placebo on change in body
weight (BW), fasting plasma glucose (FPG), systolic blood pressure (SBP) for all
patients; and to evaluate the proportion of patients with a HbA1C <7%.

- To demonstrate the superiority of sotagliflozin dose 2 versus placebo with respect to
HbA1c reduction; change in BW, FPG, and SBP for all patients; and to evaluate the
proportion of patients with HbA1c <7.0%.

- To evaluate the safety of sotagliflozin dose 1 and dose 2 compared with placebo.
Trial website
https://clinicaltrials.gov/show/NCT03386344
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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

No data has been provided for results reporting
Summary results
Other publications