This study is designed to demonstrate the CV and renal effects of sotagliflozin in patients with T2D, high CV risk, and moderate renal impairment. One of the major objectives of this study is to fulfill the regulatory mandate that any new therapy…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Diabetic complications
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* The 2 primary objectives of this study are to demonstrate that, when compared
to placebo in patients with T2D, CV risk factors, and moderately impaired renal
function, sotagliflozin:
- Is non-inferior to placebo on the composite endpoint of CV death, non-fatal
MI, or non-fatal stroke (3-point MACE)
- Reduces the composite endpoint of CV death or HHF
Secondary outcome
* The secondary objectives of this study are to demonstrate that, when
compared to placebo in patients with T2D, CV risk factors, and moderately
impaired renal function, sotagliflozin:
- Reduces the composite endpoint of CV death, non-fatal MI or non-fatal stroke
(3-point MACE)
- In patients with Baseline eGFR *30 mL/min/1.73 m2, reduces the composite
renal endpoint of sustained *50% decrease in eGFR from Baseline (for *30 days),
chronic dialysis, renal transplant, or sustained eGFR <15 mL/min/1.73 m2 (for
*30 days)
- In patients with Baseline eGFR *30 mL/min/1.73 m2 and Baseline UACR *300 mg/g
(34 mg/mmol), reduces the composite renal endpoint of sustained *50% decrease
in eGFR from Baseline (for *30 days), chronic dialysis, renal transplant, or
sustained eGFR <15 mL/min/1.73 m2 (for *30 days)
- Reduces the composite endpoint of CV death, HHF, or urgent HF visit (defined
in Appendix E)
- Reduces CV death
- Reduces all-cause mortality
* To assess the safety and tolerability of sotagliflozin in patients with T2D,
CV risk factors, and moderately impaired renal function
Background summary
Type 2 diabetes (T2D) is a growing epidemic worldwide that is associated with a
high incidence of macrovascular and microvascular complications. Type 2
diabetes is associated with cardiovascular (CV) risk factors such as
dyslipidemia, hypertension, and obesity. Although microvascular complications
have been shown to be decreased by glucose-lowering therapies, the effect on
macrovascular outcomes is not as clear. The prevalence of T2D is increasing,
and as the frequency of diabetes increases, so will its complications,
including renal impairment, CV death, and heart failure (HF). Hence, the
development of glucose-lowering therapies effective at decreasing the risk of
CV death and HF and/or the progression of renal impairment is a growing unmet
medical need.
Study objective
This study is designed to demonstrate the CV and renal effects of sotagliflozin
in patients with T2D, high CV risk, and moderate renal impairment. One of the
major objectives of this study is to fulfill the regulatory mandate that any
new therapy for T2D must demonstrate that its use does not result in an
unacceptable increase in CV risk.
Study design
This study is a Phase 3, multicenter and multinational, randomized,
double-blind,placebo-controlled, parallel-group study in approximately 10,500
patients with T2D, CV risk factors, and moderately impaired renal function. The
study will consist of 3 periods:
* A Screening period of 1 to 4 weeks
* A randomized, Double-blind Treatment period including up-titration (the dose
of sotagliflozin or matched placebo should be increased from 200 mg to 400 mg
in the first 6 months of the randomized Double-blind Treatment period, if
tolerated)
* A 14-day Post-treatment period
Intervention
Sotagliflozin 200 mg, 400 mg or placebo.
Study burden and risks
Risks and burdens related to blood collections, study procedures and possible
adverse events of study medication.
Technology Forest Place 8800
The Woodlands TX 77381-1160
US
Technology Forest Place 8800
The Woodlands TX 77381-1160
US
Listed location countries
Age
Inclusion criteria
-Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) * 7%.,
-Estimated glomerular filtration rate (eGFR) * 25 and * 60 mL/min/1.73 m2.,
-Age 18 years or older with at least one major cardiovascular risk factor or
age 55 years or older with at least two minor cardiovascular risk factors.,
-Signed written informed consent..
Exclusion criteria
-Antihyperglycemic treatment has not been stable within 12 weeks prior to
screening., -Planned coronary procedure or surgery after randomization., -Lower
extremity complications (such as skin ulcer, infection, osteomyelitis, and
gangrene) identified during screening and requiring treatment at
randomization., -Planning to start a sodium-glucose linked transporter-2
(SGLT2) inhibitor during the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-002644-32-NL |
| ClinicalTrials.gov | NCT03315143 |
| CCMO | NL63337.100.17 |