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
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | September 15, 2017 |
| End Date: | August 24, 2019 |
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)
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.
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.
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.
placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment
Follow-up Period.
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
- 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.
We found this trial at
46
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