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

ID: NCT03242252
Status: Recruiting
Phase: Phase 3
Start Date: August 16, 2017
First Submitted: August 03, 2017
Last Updated: February 23, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: Canada, Hungary, Italy, Spain, United States
Conditions: Type 2 Diabetes Mellitus-Chronic Kidney Disease Stage 3
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Study Description

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

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.
Condition or disease Intervention/treatment Phase

Type 2 Diabetes Mellitus-Chronic Kidney Disease Stage 3

Drug: Placebo
Other Names
Drug: Sotagliflozin (SAR439954)
Other Names
Phase 3

Tracking Information

First Submitted DateAugust 03, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateAugust 16, 2017
Anticipated Completion DateSeptember 01, 2019
Actual Primary Completion DateSeptember 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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)

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSafety and Efficacy Study of Sotagliflozin on Glucose Control in Patients With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Official TitleA 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 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

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 TypeInterventional
Study PhasePhase 3
Estimated Enrollment
780
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Type 2 Diabetes Mellitus-Chronic Kidney Disease Stage 3
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Placebo

Pharmaceutical form: Tablet Route of administration: Oral

Other Names
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: Tablet Route of administration: Oral

Other Names
Study Groups/Cohorts
Placebo
2 placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily before the first meal of the day - Type: Placebo Comparator

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

Dose 2
2 sotagliflozin tablets, once daily before the first meal of the day

Study Arms
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

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

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

Recruitment Information

Recruitment Status:Recruiting
Enrollment780
Completion DateSeptember 01, 2019
Eligibility 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 who could become pregnant.
- 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 will result in a short life expectancy.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Canada
Hungary
Italy
Spain
United States

Administrative Information

NCT Number:NCT03242252
Other Study ID Numbers
EFC14837
2016-004889-26
U1111-1187-8662
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi