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# FDA Approves Updated Label for Lilly’s Trulicity
- URL: https://www.fdaweb.com/fda-approves-updated-label-for-lillys-trulicity/
- Published: 2017-02-13T12:00:00.000Z
- Updated: 2026-09-14T22:06:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137962

FDA has approved an updated label for Eli Lilly’s once-weekly Trulicity (dulaglutide) to include use in combination with basal insulin for adults with Type 2 diabetes. Trulicity is a once-weekly glucagon-like peptide-1 receptor agonist injectable prescription medicine designed to improve blood sugar (glucose) in adults with Type 2 diabetes. The product is available in a prefilled pen in 0.75 and 1.5 mg doses.

  
The label update is based on FDA review of results from the [AWARD-9 clinical trial](http://lilly.mediaroom.com/index.php?s=9042&item=137560&ref=fdaweb.com), a Phase 3b, randomized, double-blind, placebo-controlled, 28-week study that evaluated the efficacy and safety of once-weekly Trulicity 1.5 mg as an add-on to titrated insulin glargine, with or without metformin, compared to placebo as an add-on to titrated insulin glargine, with or without metformin, according to the company. “Study results showed that Trulicity 1.5 mg significantly reduced A1C as an add-on to insulin glargine (1.4%) after 28 weeks compared to placebo plus insulin glargine (0.7%),” it says.