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Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

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ClinicalTrials.gov Identifier: NCT03066830
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate the superiority of sotagliflozin 400 mg versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in patients with type 2 diabetes (T2D) who have inadequate glycemic control with a sulfonylurea alone or in combination with metformin.

Secondary Objectives:

  • To compare sotagliflozin 400 mg versus placebo based on:
  • Change from baseline in fasting plasma glucose (FPG).
  • Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP ≥130 mm Hg.
  • Change from baseline in SBP for all patients.
  • Change from baseline in body weight.
  • Proportion of patients with HbA1c <6.5% and <7.0%.
  • To evaluate the safety of sotagliflozin 400 mg versus placebo throughout the 79-week trial.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Drug: placebo Drug: Metformin Drug: Sulfonylurea Phase 3

Detailed Description:
The duration per patient is up to 85 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks and a 2-week single-blind Run-in phase, a 26-week double blind Core Treatment Period, a 53 week double blind Extension, and a 2-week post treatment Follow-up period to collect safety information.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea Alone or in Combination With Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or With Metformin
Actual Study Start Date : February 24, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sotagliflozin
A dose of sotagliflozin will be administered as 2 tablets, once daily, before the first meal of the day
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral


Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral


Drug: Sulfonylurea

Pharmaceutical form: tablet

Route of administration: oral


Placebo Comparator: Placebo
A matching placebo will be administered as 2 tablets, once daily, before the first meal of the day
Drug: placebo

Pharmaceutical form: tablet

Route of administration: oral


Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral


Drug: Sulfonylurea

Pharmaceutical form: tablet

Route of administration: oral





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

Secondary Outcome Measures :
  1. Change from baseline in Fasting Plasma Glucose [ Time Frame: Baseline to Week 26 ]
  2. Change from baseline in Systolic Blood Pressure (SBP) for patients with baseline SBP ≥130 mmHg [ Time Frame: Baseline to Week 12 ]
  3. Change from baseline in SBP for all patients [ Time Frame: Baseline to Week 12 ]
  4. Change from baseline in body weight [ Time Frame: Baseline to Week 26 ]
  5. Percentage of patients with HbA1c <6.5% [ Time Frame: At Week 26 ]
  6. Percentage of patients with HbA1c <7.0% [ Time Frame: At Week 26 ]


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 T2D treated with a sulfonylurea (≥half the maximum recommended dose as per local label or maximum tolerated dose [documented]) as monotherapy or in combination with metformin (≥1500 mg per day or maximum tolerated dose [documented]) each at a stable dose for at least 12 weeks without a dose adjustment before screening.
  • Signed written informed consent.

Exclusion criteria:

  • At the time of screening, age <18 years or < legal age of majority, whichever is greater.
  • Body Mass Index (BMI) ≤20 or >45 kg/m² at Screening
  • Hemoglobin A1c (HbA1c) <7% or HbA1c >10% via central lab test at screening.
  • Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
  • Women of childbearing potential with no effective contraceptive method.
  • Treated with an antidiabetic pharmacological regimen other than a sulfonylurea at a stable dose with or without metformin within 12 weeks preceding the screening visit.
  • Previous insulin use >1 month (at any time, aside from treatment of gestational diabetes).
  • History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit.
  • History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
  • History of severe hypoglycemia within 6 months prior to the Screening visit.
  • Systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >100 mmHg or history of hypertensive emergency.
  • Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range (ULN).
  • Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome).
  • Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
  • Pregnancy, breastfeeding.
  • Patient is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the patient's diary as required per protocol.

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): NCT03066830


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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: NCT03066830     History of Changes
Other Study ID Numbers: EFC14835
2016-002826-35 ( EudraCT Number )
U1111-1186-2612 ( Other Identifier: UTN )
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 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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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action