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A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants 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
Results First Posted : June 25, 2021
Last Update Posted : June 25, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:

Primary Objective:

To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment

Secondary Objectives:

  • To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c
  • To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo
  • To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Chronic Kidney Disease Stage 4 Drug: Placebo Drug: Sotagliflozin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : May 16, 2019
Actual Study Completion Date : December 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 milligrams [mg] in appearance) orally once daily for up to 56 weeks.
Drug: Placebo
Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.

Experimental: Sotagliflozin 200 mg
Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 56 weeks.
Drug: Placebo
Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.

Drug: Sotagliflozin
Sotagliflozin 200 mg, tablet, orally, once daily.
Other Name: SAR439954

Experimental: Sotagliflozin 400 mg
Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56 weeks.
Drug: Sotagliflozin
Sotagliflozin 200 mg, tablet, orally, once daily.
Other Name: SAR439954




Primary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo [ Time Frame: Baseline to Week 26 ]
    An analysis of covariance (ANCOVA) model was used for the analysis.


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo [ Time Frame: Baseline to 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 to Week 26 ]
    An ANCOVA model was used for the analysis.

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

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

  6. 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.

  7. Percentage of Participants With HbA1c <6.5% at Week 26 [ Time Frame: Week 26 ]
  8. Percentage of Participants With HbA1c <7.0% at Week 26 [ Time Frame: Week 26 ]
  9. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks ]
    An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).


Other Outcome Measures:
  1. Percentage of Participants With Hypoglycemic Events [ Time Frame: up to 56.3 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].



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.


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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 (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 milliliter per minute (mL/min)/1.73 per meter square (m^2).
  • 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 sodium-glucose cotransporter type 2 (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 participant'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): NCT03242018


Locations
Show Show 106 study locations
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 15, 2017
Statistical Analysis Plan  [PDF] November 25, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03242018    
Other Study ID Numbers: EFC15166
2016-004906-32
U1111-1190-7589 ( Other Identifier: UTN )
First Posted: August 8, 2017    Key Record Dates
Results First Posted: June 25, 2021
Last Update Posted: June 25, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
(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