Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 (SOTA-BONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03386344
Recruitment Status : Active, not recruiting
First Posted : December 29, 2017
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Drug: Placebo Phase 3

Detailed 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.

DXA scans will be performed to assess Bone Mineral Density and Fat vs. Lean body mass at baseline and Weeks 26, 52, and 104.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose 1
Sotagliflozin dose 1 given as two (2) dose 2 sotagliflozin tablets on top of baseline antidiabetic therapy
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: Tablet

Route of administration: Oral


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
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: Tablet

Route of administration: Oral


Drug: Placebo

Pharmaceutical form: Tablet

Route of administration: Oral


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

Pharmaceutical form: Tablet

Route of administration: Oral





Primary Outcome Measures :
  1. Change in Hemoglobin A1C (HbA1c) [ Time Frame: Baseline to Week 26 ]
    Absolute change from baseline to Week 26 HbA1c (for sotagliflozin dose 1)


Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Baseline to Week 26 ]
    Absolute change from Baseline to Week 26 in HbA1c comparing sotagliflozin dose 2 versus placebo

  2. Change in body weight (BW) [ Time Frame: Baseline to Week 26 ]
    Absolute change from Baseline to Week 26 in BW (doses 1 and 2)

  3. Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 26 ]
    Absolute change from Baseline to Week 26 in FPG (doses 1 and 2)

  4. Change in systolic blood pressure (SBP) [ Time Frame: Baseline to Week 12 ]
    Absolute change from Baseline to Week 12 in SBP in all patients (dose 1 and dose 2)

  5. Patients with HbA1c < 7.0% [ Time Frame: At Week 26 ]
    Percentage of patients with HbA1c < 7.0% at Week 26 (doses 1 and 2)

  6. Percent change in bone mineral density (BMD) of lumbar spine [ Time Frame: Baseline to Week 26 ]
    Percent change in BMD of lumbar spine at week 26 (doses 1 and 2)

  7. Percent change in BMD of total hip [ Time Frame: Baseline to Week 26 ]
    Percent change in BMD of total hip at week 26 (doses 1 and 2)

  8. Percent change in BMD of femoral neck [ Time Frame: Baseline to Week 26 ]
    Percent change in BMD of femoral neck at week 26 (doses 1 and 2)

  9. Adverse events [ Time Frame: Up to 104 weeks ]
    Absolute number of patients with adverse events up to week 104 (doses 1 and 2)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386344


  Show 55 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03386344     History of Changes
Other Study ID Numbers: EFC15294
2017-002041-30
U1111-1195-6371 ( Other Identifier: UTN )
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs