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Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise

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ClinicalTrials.gov Identifier: NCT03760965
Recruitment Status : Terminated (Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to transfer sponsorship during the conduct of ongoing studies.)
First Posted : December 3, 2018
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise.

Secondary Objectives:

  • To compare sotagliflozin dose 1 versus placebo for change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT), change in fasting plasma glucose (FPG), and change in body weight.
  • To compare sotagliflozin dose 2 versus placebo for change in HbA1c, change in 2-hour PPG following a MMTT, change in FPG, and change in body weight.
  • To compare sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo for change in systolic blood pressure (SBP) for all patients, and change in SBP for patients with baseline SBP ≥130 mmHg.
  • To evaluate the safety of sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo.

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

Detailed Description:
Total study duration is up to 30 weeks, including a screening period consisting of a screening phase of up to 2 weeks and a 2-week single-blind placebo run-in phase, a 24-week double-blind treatment period, and a 2-week post-treatment follow-up visit period to collect safety information.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin as Monotherapy in Chinese Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : April 24, 2020
Actual Study Completion Date : April 24, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sotagliflozin dose 1
Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day
 Drug: sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral
Experimental: Sotagliflozin dose 2
Sotagliflozin dose 2, given as 1 sotagliflozin dose 2 tablet and 1 sotagliflozin-matching placebo tablet (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
 Drug: sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral


Drug: placebo

Pharmaceutical form: tablet

Route of administration: oral
Placebo Comparator: Placebo
Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
 Drug: placebo

Pharmaceutical form: tablet

Route of administration: oral


Outcome Measures
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Primary Outcome Measures :
  1. Change in hemoglobin A1c (HbA1c) [ Time Frame: Baseline to Week 24 ]
    Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose1)


Secondary Outcome Measures :
  1. Change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT) [ Time Frame: Baseline to Week 24 ]
    Absolute change from baseline to week 24 in 2-hour PPG following a MMTT (for sotagliflozin dose1 and 2)

  2. Change in fasting plasma glucose (FPG) [ Time Frame: Baseline to Week 24 ]
    Absolute change from baseline to week 24 in FPG (for sotagliflozin dose1 and 2)

  3. Change in body weight [ Time Frame: Baseline to Week 24 ]
    Absolute change from baseline to week 24 in body weight (for sotagliflozin dose1 and 2)

  4. Change in HbA1c [ Time Frame: Baseline to Week 24 ]
    Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 2)

  5. Change in systolic blood pressure (SBP) for all patients [ Time Frame: Baseline to Week 12 ]
    Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose1 and 2)

  6. Change in SBP for patients with baseline SBP ≥130 mmHg [ Time Frame: Baseline to Week 12 ]
    Absolute change from baseline to week 12 in SBP patients with baseline SBP ≥130 mmHg (for sotagliflozin dose1 and 2)

  7. Adverse events [ Time Frame: Up to Week 24 ]
    Number of patients with adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Chinese patients with Type 2 Diabetes who are treated with diet and exercise only during the 12 weeks prior to screening
  • Signed written informed consent.

Exclusion criteria:

  • Age <18 years at the screening visit.
  • Type 1 diabetes.
  • Hemoglobin A1c <7% or >10% measured by the central laboratory at the screening visit.
  • Fasting plasma glucose >15 mmol/L (>270 mg/dL) measured by the central laboratory at the screening visit and confirmed by a repeat test (>15 mmol/L [>270 mg/dL]) before randomization
  • Body mass index (BMI) ≤20 or >45 kg/m² at the screening visit.
  • Women of childbearing potential not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
  • Previous use of any antidiabetic medication(s) for >4 months at any time or previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes).
  • Previous use of any antidiabetic drug within 12 weeks prior to the screening visit.
  • History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the screening visit.
  • History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar coma within 12 weeks prior to the screening visit.
  • Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (diastolic blood pressure (DBP)).
  • History of hypertensive emergency within 12 weeks prior to the screening visit.
  • Patients with severe anemia, severe cardiovascular (CV) (including congestive heart failure New York Heart Association (NYHA) IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal (ULN) laboratory range.
  • Total bilirubin >1.5 times the ULN (except in case of Gilbert's syndrome).
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application, nasal spray, or inhaled forms) for more than 10 consecutive days within 90 days prior to the screening visit.
  • Patient who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives prior to the screening visit, whichever is longer.
  • Pregnant (confirmed by serum pregnancy test at the screening visit) or breastfeeding women.
  • Patients with severe renal disease as defined by an eGFR of <30 mL/min/1.73m² at the screening visit, based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation.
  • Patient unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the patient diary, or comply with study visits and other study procedures as required per protocol.
  • Patients unable to consume at least 50% of the standard meal during the MMTT at baseline (Day 1, Visit 3) before randomization.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations
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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): NCT03760965


Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03760965    
Other Study ID Numbers: EFC15194
U1111-1195-6181 ( Other Identifier: UTN )
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
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/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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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