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Safety and Efficacy Study of Sotagliflozin on Glucose Control in Patients 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 : Active, not recruiting
First Posted : August 8, 2017
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 and 2 versus placebo on HbA1c reduction in patients with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment

Secondary Objectives:

  • To assess the effects of sotagliflozin dose 1 and 2 versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight
  • To evaluate the safety of sotagliflozin dose 1 and dose 2 versus placebo

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus-Chronic Kidney Disease Stage 3 Drug: Placebo Drug: Sotagliflozin (SAR439954) 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)
Estimated Enrollment : 780 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 Moderate Renal Impairment Who Have Inadequate Glycemic Control
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : April 4, 2019
Estimated Study Completion Date : October 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
2 placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily before the first meal of the day - Type: Placebo Comparator
Drug: Placebo

Pharmaceutical form: Tablet

Route of administration: Oral


Experimental: Dose 1
2 tablets: 1 sotagliflozin tablet and 1 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


Experimental: Dose 2
2 sotagliflozin tablets, once daily before the first meal of the day
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: Tablet

Route of administration: Oral





Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Baseline to Week 26 ]
    Change from Baseline in HbA1c (dose 1)

  2. Change in HbA1c [ Time Frame: Baseline to Week 26 ]
    Change from Baseline in HbA1c (dose 2)


Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 26 ]
    Change from Baseline at Week 26 in FPG (doses 1 and 2)

  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)

  3. 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)

  4. Change in body weight [ Time Frame: Baseline to Week 26 ]
    Change from Baseline at Week 26 in body weight (doses 1 and 2)

  5. 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)

  6. 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)

  7. 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)

  8. Patients with adverse events [ Time Frame: Week 56 ]
    Proportion of patients with adverse events over the study period (doses 1 and 2)



Information from the National Library of Medicine

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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 :

  • Patients 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 mL/min/1.73 m2 (CKD 3A, 3B).
  • Patient 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 an SGLT2 inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
  • Uncontrolled high blood pressure.
  • Patients 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 patient'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): NCT03242252


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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03242252     History of Changes
Other Study ID Numbers: EFC14837
2016-004889-26
U1111-1187-8662 ( Other Identifier: UTN )
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
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 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

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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