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- Title
Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study.
- Authors
Ishii, Hitoshi; Onishi, Yukiko; Oura, Tomonori; Takeuchi, Masakazu
- Abstract
Introduction: Although global studies have investigated the combination of dulaglutide with insulin in patients with type 2 diabetes mellitus (T2DM), differences in lean body mass and dulaglutide dosing can complicate the extrapolation of global study results to Japanese patients. This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM. Methods: Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5–10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs). Patients were randomized in a 3:1 ratio to dulaglutide or placebo. The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total). Results: Patients (N = 159) were randomized to dulaglutide (n = 120) or placebo (n = 39). The least-squares (LS) mean changes from baseline in HbA1c at week 16 were dulaglutide − 1.45% and placebo 0.06%. The LS mean and 95% confidence interval for the difference were − 1.50% (− 1.73%, − 1.28%) and dulaglutide was superior to placebo. There were no significant differences between treatment groups in changes from baseline in body weight and insulin dose. The most frequently observed treatment-emergent adverse events in dulaglutide were nasopharyngitis, constipation, abdominal discomfort, nausea, and decreased appetite. The incidence rates of hypoglycemic events by week 16 were dulaglutide 42.5% and placebo 30.8% (P = 0.258). Conclusion: Once-weekly dulaglutide 0.75 mg was superior to once-weekly placebo in glycemic control improvement and well tolerated in patients with T2DM in combination with insulin therapy with or without OADs. Trial Registration: ClinicalTrials.gov, NCT02750410. Funding: Eli Lilly and Company.
- Subjects
ELI Lilly &; Co.; TYPE 2 diabetes; INSULIN; LEAN body mass; GLYCEMIC control
- Publication
Diabetes Therapy, 2020, Vol 11, Issue 1, p133
- ISSN
1869-6953
- Publication type
Article
- DOI
10.1007/s13300-019-00726-8