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Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

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: NCT02926950
Recruitment Status : Completed
First Posted : October 6, 2016
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Study Description
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Brief Summary:

Primary Objective:

To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control with metformin.

Secondary Objectives:

  • To compare Sotagliflozin versus placebo for.
  • Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
  • Change from baseline in fasting plasma glucose (FPG).
  • Change from Baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mmHg).
  • Change from baseline in SBP for all participants.
  • Change from baseline in body weight.
  • Proportion of participants with HbA1c <6.5% and <7.0%.
  • To evaluate the safety of Sotagliflozin versus placebo.

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

Detailed Description:
The duration of the study period is up to 87 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks and a 2 week single blind Run-in phase, a 26 week double-blind Core Treatment Period, a 53-week double-blind Extension Period, a 4 week post treatment Follow-up period to collect safety information.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 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 Added to Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 26, 2019
Actual Study Completion Date : March 22, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sotagliflozin 400 mg + Metformin
Following a 2-week run-in period, sotagliflozin 400 mg was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
 Drug: Sotagliflozin (SAR439954)
Pharmaceutical form: tablet. Route of administration: oral.

Drug: Metformin
Pharmaceutical form: tablet. Route of administration: oral.
Placebo Comparator: Placebo + Metformin
Following a 2-week run-in period, matching placebo was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
 Drug: Placebo
Pharmaceutical form: tablet. Route of administration: oral.

Drug: Metformin
Pharmaceutical form: tablet. Route of administration: oral.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [ Time Frame: Baseline and Week 26 ]
    An analysis of covariance (ANCOVA) model was used for the analysis.


Secondary Outcome Measures :
  1. Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26 [ Time Frame: Baseline and Week 26 ]
    An ANCOVA model was used for the analysis.

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: Baseline and Week 26 ]
    An ANCOVA model was used for the analysis.

  3. Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline and Week 26 ]
    An ANCOVA model was used for the analysis.

  4. Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 mmHg [ Time Frame: Baseline and Week 12 ]
    An ANCOVA model was used for the analysis.

  5. Change From Baseline in SBP at Week 12 for All Participants [ Time Frame: Baseline and Week 12 ]
    An ANCOVA model was used for the analysis.

  6. Percentage of Participants With HbA1c <6.5% at Week 26 [ Time Frame: Week 26 ]
  7. Percentage of Participants With HbA1c <7.0% at Week 26 [ Time Frame: Week 26 ]

Other Outcome Measures:
  1. Percentage of Participants With Hypoglycemic Events [ Time Frame: Up to 79 weeks in the treatment period ]
    Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤70 mg/dL]. Participants may be reported in more than one category.


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 :

  • Participants with Type 2 Diabetes currently treated with diet and exercise and on metformin at a stable dose ≥1500 milligrams per day (mg/day) for at least 12 weeks. However, participants on metformin at a dose <1500 mg/day at the time of enrollment (stable dose for at least 12 weeks before enrollment) may be eligible for screening if documentation of lack of tolerance of a metformin dose ≥1500 mg/day can be provided.
  • Signed written informed consent.

Exclusion criteria:

  • Age <18 years at Screening or < legal age of majority, whichever is greater.
  • Type 1 diabetes mellitus.
  • Body Mass Index (BMI) ≤20 or >45 kilograms per meter square (kg/m^2) at Screening
  • Hemoglobin A1c <7% or >10% via central laboratory test at screening.
  • Fasting plasma glucose (FPG) >15 millimole per liter (mmol/L) (270 milligrams per deciliter [mg/dL]) measured by the central laboratory at screening (Visit 1) and confirmed by a repeat test (>15 mmol/L [270 mg/dL]) before randomization.
  • Women of childbearing potential not willing to use highly effective method(s) of birth control or who are unwilling or unable to be tested for pregnancy during the study.
  • Treated with an antidiabetic pharmacological regimen other than metformin ≥1500 mg per day (or maximum tolerated dose) within the 12 weeks preceding the Screening Visit.
  • Previous use of any types of insulin for >1 month (at any time, aside from pregnancy for treatment of gestational diabetes).
  • History of prior gastric surgical procedure, including gastric banding, within 3 years before the Screening Visit.
  • History of diabetic ketoacidosis or nonketotic 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 urgency or emergency within 12 weeks prior to Screening.
  • Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association [NYHA] IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or participants with short life expectancy making implementation of the protocol or interpretation of the study results difficult.
  • Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range.
  • Total bilirubin: >1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome).
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
  • Participants who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives from screening or randomization, whichever is longer.
  • Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.
  • Participants is unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the participants diary, or comply with study visits and other study procedures as required per protocol.
  • Contraindication to metformin as per local labelling.

The above information is not intended to contain all considerations relevant to a participant'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): NCT02926950


Locations
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Sponsors and Collaborators
Lexicon Pharmaceuticals
Sanofi
Investigators
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Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Lexicon Pharmaceuticals:
Study Protocol  [PDF] December 21, 2017
Statistical Analysis Plan  [PDF] December 13, 2019

More Information
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02926950    
Other Study ID Numbers: EFC14834
2016-001800-49 ( EudraCT Number )
U1111-1181-6145 ( Other Identifier: UTN )
First Posted: October 6, 2016    Key Record Dates
Results First Posted: May 11, 2021
Last Update Posted: May 11, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

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