Insulin glargine-aldy U.S. label context · version 1
This page preserves this version's wording and source pins. Open the current profile →
What does the U.S. product label say?
Langlara · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The cited Langlara label covers glycemic control in adults and children with diabetes mellitus. It does not cover treatment of diabetic ketoacidosis. Label: 1 ↗
What clinical studies does the label describe?
Section 14 summarizes open-label randomized comparisons of insulin glargine with NPH insulin involving 2,327 adults and 349 children with type 1 diabetes and 1,563 adults with type 2 diabetes. HbA1c reductions were generally similar. These are the label’s insulin-glargine clinical studies, not a count of trials conducted specifically with insulin glargine-aldy. Label: 14.1, 14.2, 14.3 ↗
Which safety limits matter?
The label describes potentially life-threatening hypoglycemia, severe hypersensitivity, low potassium, medication errors and fluid retention or heart failure with thiazolidinediones. Hypoglycemia episodes and relevant hypersensitivity are contraindications. Label: 4, 5 ↗
Label edition and source pins
U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
LANGLARA (insulin glargine-aldy) injection, solution · SPL version 5 · published 2026-07-08
Label ZIP SHA-256: c393585bbdb741f3ff47b5db3b45ed1dfc84a10d2d03e83796d8aae94d3ad187. Extracted XML SHA-256: a785c2958a54aeb8984fecab009a9c899d5b73479104b4d2ae4982ac6f32f770.