Diabetes Trial Files Throwback Thursday: Liraglutide and CVD Endpoints in T2DM, Basal-bolus Insulin in T2DM, and ACE+ARB in DM Nephropathy
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes
Marso SP et al. NEJM (July 2016)
Bottom Line: This double-blind trial evaluated the cardiovascular effects of liraglutide, a glucagon-like peptide 1 analogue, in patients with type 2 diabetes and high cardiovascular risk. A total of 9340 patients were randomly assigned to receive liraglutide or placebo for a median follow-up of 3.8 years. The primary outcome of first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke was significantly lower in the liraglutide group compared to placebo. Liraglutide was also associated with lower rates of all-cause mortality and adverse events leading to discontinuation. The most common adverse events were gastrointestinal in nature.
Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes (RABBIT 2)
Umpierrez GE et al. Diabetes Care (September 2007)
Bottom Line: This prospective, multicenter, randomized trial compared the efficacy and safety of a basal-bolus insulin regimen with that of sliding-scale regular insulin (SSI) in 130 insulin-naive patients with type 2 diabetes. The intervention group received glargine and glulisine at starting doses of 0.4-0.5 units/kg/day, while the comparator group received SSI. The primary outcome was achieving a blood glucose target of <140 mg/dl, which was achieved in 66% of the intervention group and 38% of the comparator group. The intervention group also had a significantly lower mean daily blood glucose and no differences in hypoglycemia or length of hospital stay. The study concluded that a basal-bolus insulin regimen is preferred over SSI for managing non-critically ill, hospitalized patients with type 2 diabetes.
Combined Angiotensin Inhibition for the Treatment of Diabetic Nephropathy
Fried LF et al. NEJM (November 2013)
Bottom Line: This randomized controlled trial evaluated the safety and efficacy of combination therapy with losartan and lisinopril in patients with type 2 diabetes, proteinuria, and decreased kidney function. The study was stopped early due to safety concerns. The primary outcome was a decline in estimated GFR, ESRD, or death. There was no significant difference in primary or secondary outcomes between the intervention and control groups. However, combination therapy was associated with an increased risk of hyperkalemia and acute kidney injury. In conclusion, combination therapy with an ACE inhibitor and an ARB did not show a significant benefit and was associated with an increased risk of adverse events in this patient population.
Diabetes Trial Files Issue #DIA-2025-04
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