Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate Safety and Effects of Sotagliflozin Dose 1 and Dose 2 on Glucose Control in Patients With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control (SOTA-CKD4)

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: NCT03242018
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : May 22, 2020
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
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE August 16, 2017
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
Change in HbA1c [ Time Frame: Baseline to Week 26 ]
Change from Baseline at Week 26 in HbA1c comparing sotagliflozin dose 1 versus placebo in CKD4 patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • Change in HbA1c [ Time Frame: Baseline to Week 26 ]
    Change from Baseline at Week 26 in HbA1c comparing sotagliflozin dose 2 versus placebo
  • 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 SBP greater than or equal to 130 mmHg (doses 1 and 2)
  • Change in SBP [ Time Frame: Baseline to Week 12 ]
    Change from Baseline at Week 12 in SBP in all patients (dose 1 and dose 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 the UACR from Baseline to Week 26 for patients with a UACR > 30 mg/g at baseline (doses 1 and 2)
  • Patients with HbA1c less than 6.5% [ Time Frame: Week 26 ]
    Percentage 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 ]
    Percentage of patients with HbA1c less than 7.0% at Week 26 (doses 1 and 2)
  • Adverse events [ Time Frame: Week 52 ]
    Number of patients with adverse events up to week 52 (doses 1 and 2)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety and Effects of Sotagliflozin Dose 1 and Dose 2 on Glucose Control in Patients With Type 2 Diabetes, Severe 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 Severe Renal Impairment Who Have Inadequate Glycemic Control
Brief Summary

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to hemoglobin A1c (HbA1c) reduction in patients with Type 2 diabetes who have inadequate glycemic control and severe renal impairment

Secondary Objectives:

  • To assess the effects of sotagliflozin dose 2 versus placebo based on change from baseline in HbA1c
  • To assess the effects of sotagloflozin doses 1 and 2 versus placebo
  • To evaluate the safety of sotagliflozin doses 1 and 2 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Chronic Kidney Disease Stage 4
Intervention  ICMJE
  • Drug: Placebo

    Pharmaceutical form: Tablet

    Route of administration: Oral

  • Drug: Sotagliflozin (SAR439954)

    Pharmaceutical form: Tablet

    Route of administration: Oral

Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Given as two placebo tablets (identical to sotagliflozin dose 2 in appearance) orally once daily
    Intervention: Drug: Placebo
  • Experimental: Dose 1
    Given as two sotagliflozin dose 2 tablets orally once daily
    Intervention: Drug: Sotagliflozin (SAR439954)
  • Experimental: Dose 2
    Given as two tablets: one sotagliflozin dose 2 tablet and one placebo tablet (identical to sotagliflozin dose 2 in appearance) orally once daily
    Interventions:
    • Drug: Placebo
    • Drug: Sotagliflozin (SAR439954)
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: February 19, 2020)
277
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2017)
276
Actual Study Completion Date  ICMJE December 11, 2019
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Patients with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD) equation) of ≥15 and <30 mL/min/1.73 m2.
  • Signed written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

  • At the time of screening, age <18 years.
  • Hemoglobin A1c (HbA1c) <7% or >11%.
  • 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 an SGLT2 inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
  • 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, 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 patient'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,   Colombia,   Germany,   Hungary,   Israel,   Italy,   Mexico,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03242018
Other Study ID Numbers  ICMJE EFC15166
2016-004906-32
U1111-1190-7589 ( 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: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in 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
Responsible Party Lexicon Pharmaceuticals
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Lexicon Pharmaceuticals
Verification Date May 2020

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