Type 2 diabetes comparable A1C reduction
BASAGLAR demonstrated noninferiority to Lantus® (insulin glargine injection) products (approved in the US or outside the US) as measured by A1C reduction in adult patients with type 2 diabetes1,4
Type 2 diabetes: change in A1C from baseline at 24 weeks
Difference of 0.052% (95% CI -0.070 to 0.175)
Noninferiority margin 0.4% and then 0.3%
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Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.
A comparable percentage of adult patients with type 2 diabetes achieved A1C <7% at 24 weeks1,4*
BASAGLAR + OAMs
(n=376†; baseline A1C: 8.35%)
Lantus products‡ + OAMs
(n=380†; baseline A1C: 8.31%)
Trial design: 24-week phase 3, randomized, double-blind trial of 756 adult patients with type 2 diabetes who were either insulin-naive and failed to achieve adequate glycemic control on at least 2 OAMs, or were already on Lantus products (approved in the US or outside the US) along with 2 or more OAMs with adequate or inadequate glycemic control. The primary endpoint was noninferiority of BASAGLAR to Lantus products (approved in the US or outside the US) as measured by change in A1C from baseline at 24 weeks.1,4
The starting dose for all insulin-naive patients was 10 units/day, while patients entering the study on Lantus products (approved in the US or outside the US) were randomized to either BASAGLAR or Lantus products (approved in the US or outside the US) at a dose equivalent to their prestudy Lantus products (approved in the US or outside the US) dose. BASAGLAR and Lantus products (approved in the US or outside the US) titrations were patient-driven based on self-measured fasting plasma glucose with a target of ≤100 mg/dL.4
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Adverse reactions commonly associated with insulin glargine products (5% or greater incidence) are: hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain.
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with BASAGLAR.