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Efficacy and Safety of Sotagliflozin Versus Placebo in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents (SOTA-INS)

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ClinicalTrials.gov Identifier: NCT03285594
Recruitment Status : Active, not recruiting
First Posted : September 18, 2017
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to HbA1c (glycosylated hemoglobin) reduction in patients with T2D (type 2 diabetes mellitus) who have inadequate glycemic control on basal insulin alone or with OADs (oral antidiabetic drugs).

Secondary Objectives:

  • To assess the effects of sotagliflozin dose 1 versus placebo on Fasting Plasma Glucose (FPG), body weight, Systolic Blood Pressure (SBP), and HbA1c.
  • To assess the effects of sotagliflozin dose 2 versus placebo on HbA1c, body weight, FPG, and SBP.
  • To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: sotagliflozin (SAR439954) Drug: insulin glargine (HOE901) Drug: Placebo Phase 3

Detailed Description:
Up to 60 weeks (Screening phase of up to 2 weeks, a 4-week Lantus titration/single-blind placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment Follow-up Period.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : August 24, 2019
Estimated Study Completion Date : August 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose 1
Dose 1 of sotagliflozin (SAR439954) will be administered as two tablets, taken orally once daily, before first meal of the day. Background therapy with insulin glargine (Lantus) (with or without OADs) will continue throughout the study.
Drug: sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral


Drug: insulin glargine (HOE901)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Lantus

Experimental: Dose 2
Dose 2 of sotagliflozin (SAR439954) will be administered as one tablet plus one placebo tablet, taken orally once daily, before first meal of the day. Background therapy with insulin glargine (Lantus) (with or without OADs) will continue throughout the study.
Drug: sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral


Drug: insulin glargine (HOE901)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Lantus

Placebo Comparator: Placebo
Two placebo tablets, taken orally once daily, before first meal of the day. Background therapy with insulin glargine (Lantus) (with or without OADs) will continue throughout the study.
Drug: insulin glargine (HOE901)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Lantus

Drug: Placebo

Pharmaceutical form: tablet

Route of administration: oral





Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Baseline to week 18 ]
    Absolute change from baseline in hemoglobin A1c (HbA1c ) (for sotagliflozin dose 1)


Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose [ Time Frame: Baseline to week 18 ]
    Absolute change from baseline in FPG (for sotagliflozin dose 1 and dose 2)

  2. Change in Systolic Blood Pressure (SBP) for patients with Baseline SBP ≥130 mmHg [ Time Frame: Baseline to week 12 ]
    Absolute change from baseline in SBP for patients with baseline SBP ≥130 mmHg (for sotagliflozin dose 1 and dose 2)

  3. Change in SBP for all patients [ Time Frame: Baseline to week 12 ]
    Absolute change from baseline in SBP for all patients (for sotagliflozin dose 1)

  4. Change in Body Weight [ Time Frame: Baseline to week 18 ]
    Absolute change from baseline in Body Weight (for sotagliflozin dose 1 and dose 2)

  5. Change in Body Weight [ Time Frame: Baseline to week 52 ]
    Absolute change from baseline in Body Weight (for sotagliflozin dose 1 and dose 2)

  6. Change in HbA1c [ Time Frame: Baseline to week 52 ]
    Absolute change from baseline in hemoglobin A1c (HbA1c) (for sotagliflozin dose 1 and dose 2)

  7. Change in HbA1c [ Time Frame: Baseline to week 18 ]
    Absolute change from baseline in hemoglobin A1c (HbA1c) (for sotagliflozin dose 2)

  8. Adverse events [ Time Frame: Up to week 52 ]
    Proportion of patients with adverse events



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 (Type 2 diabetes) using any types of basal insulin alone or in combination with up to 2 OADs (oral antidiabetic drugs).
  • Patient has given written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

  • At the time of Screening age <18 years or <legal age of majority, whichever is greater.
  • Type 1 diabetes mellitus.
  • Oral antidiabetic drugs dose not stable for 8 weeks before Screening.
  • Use of basal insulin therapy (e.g., insulin glargine, Neutral Protamine Hagedorn (NPH), detemir, or degludec) for less than 6 months before Screening.
  • Dose of basal insulin (e.g., insulin glargine, NPH, detemir, or degludec) not stable for 8 weeks before Screening (i.e., total daily insulin dose increased or decreased by more than 20%).
  • Known unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema that is likely to require laser, surgical treatment during study period.
  • Use of injectable diabetes drugs other than basal insulin (e.g., insulin glargine, NPH, detemir, or degludec), i.e., prandial or rapid-acting insulins, short-acting insulins, GLP-1 (glucagon-like peptide 1) receptor agonists, or inhaled prandial insulin (Afrezza) within 8 weeks of Screening.
  • Use of a selective SGLT2 inhibitor (e.g., canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to the trial.
  • Use of systemic glucocorticoids (excluding topical, intra articular, or ophthalmic application, nasal spray or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
  • 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 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.
  • Known presence of factors that interfere with the Central Lab HbA1c measurement (e.g., genetic Hb variants) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (e.g., blood transfusion or severe blood loss in the last 3 months prior to randomization, any condition that shortens erythrocyte survival).
  • Patient who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives from prior to Screening, whichever is longer.
  • Patients unwilling to perform SMBG (self-monitoring of blood glucose), complete the patient diary or comply with study visits and other study procedures as required per protocol.
  • Hemoglobin A1c (HbA1c) <7.5% or HbA1c >10.5% measured by the central laboratory at Screening.
  • HbA1c <7% measured by the central laboratory at Visit 5 (Week -1).
  • History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
  • Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.
  • Women of childbearing potential 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.
  • Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (diastolic blood pressure (DBP)).
  • History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the Screening Visit.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal laboratory range
  • Total bilirubin >1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome).

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): NCT03285594


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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03285594     History of Changes
Other Study ID Numbers: EFC14868
2016‐001804‐43 ( EudraCT Number )
U1111-1190-7567 ( Other Identifier: UTN )
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
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

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs