Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Subjects With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | December 1, 2017 |
| End Date: | August 6, 2019 |
A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Glimepiride or Placebo Added to Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy
Primary Objective:
To demonstrate the non-inferiority of sotagliflozin dose 1 compared to glimepiride on HbA1c
(glycosylated A1c) reduction in patients with T2D (type 2 diabetes) who have inadequate
glycemic control with metformin.
Secondary Objectives:
To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change in
body weight, SBP (systolic blood pressure) in patients with baseline SBP ≥130 mmHg, SBP in
all patients, and proportion of patients with at least 1 documented symptomatic hypoglycemic
event (≤70 mg/dL).
- To demonstrate the superiority of sotagliflozin dose 1 compared to placebo on change in
HbA1c, body weight, SBP in patients with baseline SBP ≥130 mmHg, SBP in all patients.
- To demonstrate the superiority of sotagliflozin dose 2 compared to placebo on change in
HbA1c.
- To demonstrate the non-inferiority of sotagliflozin dose 2 compared to glimepiride on
change in HbA1c.
- To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change
in HbA1c.
- To evaluate the safety and tolerability of sotagliflozin compared to glimepiride and
placebo.
To demonstrate the non-inferiority of sotagliflozin dose 1 compared to glimepiride on HbA1c
(glycosylated A1c) reduction in patients with T2D (type 2 diabetes) who have inadequate
glycemic control with metformin.
Secondary Objectives:
To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change in
body weight, SBP (systolic blood pressure) in patients with baseline SBP ≥130 mmHg, SBP in
all patients, and proportion of patients with at least 1 documented symptomatic hypoglycemic
event (≤70 mg/dL).
- To demonstrate the superiority of sotagliflozin dose 1 compared to placebo on change in
HbA1c, body weight, SBP in patients with baseline SBP ≥130 mmHg, SBP in all patients.
- To demonstrate the superiority of sotagliflozin dose 2 compared to placebo on change in
HbA1c.
- To demonstrate the non-inferiority of sotagliflozin dose 2 compared to glimepiride on
change in HbA1c.
- To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change
in HbA1c.
- To evaluate the safety and tolerability of sotagliflozin compared to glimepiride and
placebo.
Up to 58 weeks, including a Screening Period consisting of a Screening phase of up to 2
weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period,
and a 2-week post-treatment Follow-up period to collect safety information.
weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period,
and a 2-week post-treatment Follow-up period to collect safety information.
Inclusion criteria :
- Patients with Type 2 Diabetes (T2D) treated with metformin at a stable dose ≥1500
mg/day or maximum tolerated dose (documented) for at least 12 weeks prior to Screening
Visit; in case of documented lack of tolerance, metformin dose <1500 mg/day is
acceptable, and the dose should be stable for at least 12 weeks prior to Screening
Visit.
- Patient has given written informed consent to participate in the study in accordance
with local regulations..
Exclusion criteria:
- Age <18 years at the Screening Visit or
- Type 1 diabetes mellitus.
- HbA1c <7.0% or HbA1c >10% at Screening.
- Fasting Plasma Glucose (FPG) >15 mmol/L (>270 mg/dL) measured by the central
laboratory at Screening (Visit 1) and confirmed by a repeat test (>15 mmol/L [>270
mg/dL]) before randomization.
- Body mass index ≤20 or >45 kg/m² at Screening.
- Pregnant (confirmed by pregnancy test at the Screening) or breast-feeding women.
- 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 (see Appendix A) during the study.
- Previous use of any antidiabetic drug other than metformin within 12 weeks preceding
the Screening Visit.
- Use of a selective SGLT2 inhibitor (e.g., canagliflozin, dapagliflozin, or
empagliflozin) within 3 months prior to the Screening visit.
- Use of systemic glucocorticoids (excluding topical, or ophthalmic application,
intra-articular, nasal spray or inhaled forms) for more than 10 consecutive days
within 90 days prior to the Screening Visit.
- Previous insulin use >1 month (at any time, except for treatment of gestational
diabetes).
- History of prior gastric surgical procedure, including gastric banding, or
inflammatory bowel disease within 3 years prior to the Screening Visit.
- Difficulty swallowing such that the patient cannot take the investigational medicinal
product (IMP).
- History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior
to the Screening Visit.
- Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (DBP).
- History of hypertensive emergency within 12 weeks prior to Screening.
- Patients who have previously been randomized in any clinical trial of
sotagliflozin/LX4211.
- Patients with severe renal disease as defined by an eGFR of <30 mL/min/1.73 m² at
Screening, based on the 4 variable Modification of Diet in Renal Disease (MDRD)
equation (or according to the renal function restrictions of metformin use defined in
the local approved label).
- 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
Investigator, will preclude their safe participation in this study, or will make
implementation of the protocol or interpretation of the study results difficult.
- 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).
- Patients who have taken other investigational drugs within 12 weeks or 5 half-lives
from Screening whichever is longer.
- Patients unwilling or unable to perform self-monitoring blood glucose (SMBG), complete
the patient diary, or comply with study visits and other study procedures as required
per protocol.
- Patients with contraindication to glimepiride as per local labeling.
- Patients with contraindication to metformin as per local labeling.
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
103
sites
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