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Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control (SOTA-CKD3)

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: NCT03242252
Recruitment Status : Completed
First Posted : August 8, 2017
Results First Posted : June 25, 2021
Last Update Posted : June 25, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 3, 2017
First Posted Date  ICMJE August 8, 2017
Results First Submitted Date  ICMJE April 16, 2021
Results First Posted Date  ICMJE June 25, 2021
Last Update Posted Date June 25, 2021
Actual Study Start Date  ICMJE August 16, 2017
Actual Primary Completion Date March 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2021)
Change From Baseline in HbA1c at Week 26 [ Time Frame: Baseline to Week 26 ]
An Analysis of covariance (ANCOVA) model was used for analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • Change in HbA1c [ Time Frame: Baseline to Week 26 ]
    Change from Baseline in HbA1c (dose 1)
  • Change in HbA1c [ Time Frame: Baseline to Week 26 ]
    Change from Baseline in HbA1c (dose 2)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2021)
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: Baseline to Week 26 ]
    An ANCOVA model was used for analysis.
  • Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12 [ Time Frame: Baseline to Week 12 ]
    An ANCOVA model was used for analysis.
  • Change From Baseline in SBP at Week 12 for All Participants [ Time Frame: Baseline to Week 12 ]
    An ANCOVA model was used for analysis.
  • Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline to Week 26 ]
    An ANCOVA model was used for analysis.
  • Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g) [ Time Frame: Baseline to Week 26 ]
    An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.
  • Percentage of Participants With HbA1c <6.5% at Week 26 [ Time Frame: Week 26 ]
  • Percentage of Participants With HbA1c <7.0% at Week 26 [ Time Frame: Week 26 ]
  • Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 60 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 26 ]
    Change from Baseline at Week 26 in FPG (doses 1 and 2)
  • Change in Systolic Blood Pressure (SBP) for patients with SBP ≥130 mmHg [ Time Frame: Baseline to Week 12 ]
    Change from Baseline in SBP at Week 12 for patients with baseline SBP ≥130 mmHg (doses 1 and 2)
  • Change in Systolic Blood Pressure (SBP) [ Time Frame: Baseline to Week 12 ]
    Change from Baseline in SBP at Week 12 for all patients (doses 1 and 2)
  • Change in body weight [ Time Frame: Baseline to Week 26 ]
    Change from Baseline at Week 26 in body weight (doses 1 and 2)
  • Change in urinary albumin-to-creatinine ratio (UACR) [ Time Frame: Baseline to Week 26 ]
    Percentage change in UACR from Baseline to Week 26 for patients with UACR > 30 mg/g (doses 1 and 2)
  • Patients with HbA1c less than 6.5% [ Time Frame: Week 26 ]
    Proportion of patients with HbA1c less than 6.5% at Week 26 (doses 1 and 2)
  • Patients with HbA1c less than 7.0% [ Time Frame: Week 26 ]
    Proportion of patients with HbA1c less than 7.0% at Week 26 (doses 1 and 2)
  • Patients with adverse events [ Time Frame: Week 56 ]
    Proportion of patients with adverse events over the study period (doses 1 and 2)
Current Other Pre-specified Outcome Measures
 (submitted: April 16, 2021)
Percentage of Participants With Hypoglycemic Events [ Time Frame: Up to 60 weeks ]
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].
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
Brief Summary

Primary Objective:

To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment.

Secondary Objectives:

  • To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight.
  • To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.
Detailed Description The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment, and a visit 4 weeks after completion of the randomized treatment period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Chronic Kidney Disease Stage 3
Intervention  ICMJE
  • Drug: Placebo

    Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily.

    Route of administration: Oral

  • Drug: Sotagliflozin

    Sotagliflozin 200 mg, tablet, orally once daily.

    Route of administration: Oral

    Other Name: SAR439954
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
    Intervention: Drug: Placebo
  • Experimental: Sotagliflozin 200 mg
    Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
    Interventions:
    • Drug: Placebo
    • Drug: Sotagliflozin
  • Experimental: Sotagliflozin 400 mg
    Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
    Intervention: Drug: Sotagliflozin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2019)
787
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2017)
780
Actual Study Completion Date  ICMJE October 25, 2019
Actual Primary Completion Date March 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30 and <60 milliliter per minute (mL/min)/1.73 meter square (m^2) (chronic kidney disease [CKD] 3A, 3B).
  • Participants has given written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

  • Hemoglobin A1c (HbA1c) of <7.0% or >11.0%.
  • Type 1 diabetes.
  • Women of childbearing potential (WOCBP) 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.
  • Treatment with a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin, Dapagliflozin, Empagliflozin) during the last 12 months.
  • Uncontrolled high blood pressure.
  • Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
  • Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Colombia,   Germany,   Hungary,   Israel,   Italy,   Mexico,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03242252
Other Study ID Numbers  ICMJE EFC14837
2016-004889-26
U1111-1187-8662 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lexicon Pharmaceuticals
Original Responsible Party Sanofi
Current Study Sponsor  ICMJE Lexicon Pharmaceuticals
Original Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.
PRS Account Lexicon Pharmaceuticals
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP