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To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam.
To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to that of cocktail probes alone.
The total study duration per subject is up to 58 days.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Type 2 Diabetes Mellitus
sotagliflozin (SAR439954), midazolam, metoprolol
Not yet recruiting
Published on BioPortfolio: 2016-10-21T04:08:21-0400
Primary Objective: - To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compa...
Primary Objective: To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic c...
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 ina...
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 me...
Primary Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in patients with type 2 diabetes (T2D) who have i...
To evaluate the evidence for the novel dual sodium-glucose co-transporter-1 and -2 inhibitor, sotagliflozin, which may enhance the efficacy of sodium-glucose co-transporter-2 inhibitors by additionall...
Obesity and type 2 diabetes mellitus are prevalent all over the world. Obese patients with more visceral fat are more likely to suffer from type 2 diabetes mellitus, hypertension, dyslipidemia and obs...
The association between type 1 diabetes mellitus (T1DM) and specific cardiovascular diseases (CVD) is uncertain. Furthermore, data on type 2 diabetes mellitus (T2DM) in relation to risk of aortic valv...
Despite improved understanding of the pathophysiology of type 2 diabetes mellitus, explanations for individual variability in disease progression and response to treatment are incomplete. The gut micr...
A UHPLC-MS/MS method coupled with liquid-liquid extraction for the quantitation of phenacetin, omeprazole, metoprolol, midazolam and their metabolites in rat plasma and its application to the study of four CYP450 activities.
Drug-drug interactions (DDIs) are thought to be associated with the inhibition of cytochrome P450 activities. The cocktail method with analysis of the metabolism of two or more probe drugs is used to ...
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.
A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).
A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.
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