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Completed

NCT Number: NCT03242018

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Chronic Disease Chronic Kidney Disease Stage 4 Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 0325001, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

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

Sotagliflozin

Drug

Sotagliflozin 200 mg, tablet, orally, once daily.

Other names: SAR439954

Primary outcomes

  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 outcomes

  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 outcomes

  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].

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study 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

Acronym: SOTA-CKD4

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2017
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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