ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2020
Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02750410. Cited by 5 papers, 1 of them a synthesis that pooled it.
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The trial behind it
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A Phase 4 Study of Efficacy and Safety of Dulaglutide When Added to Insulin Treatment With or Without Oral Antidiabetic Medication in Patients With Type 2 Diabetes
Open the trial in the graphWho cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Impact of GLP-1 Receptor Agonists on Suicide Behavior: A Meta-Analysis Based on Randomized Controlled Trials.Journal of diabetes · 2025 · on this mapPooled it
- Efficacy and Safety of Tirzepatide Compared with GLP-1 RAs in Patients with Type 2 Diabetes Treated with Basal Insulin: A Network Meta-analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.Journal of diabetes investigation · 2023Observational
- Real-World Efficacy and Safety of Dulaglutide in Korean Patients with Type 2 Diabetes Mellitus: A Retrospective Study in a Tertiary Referral Center.Chonnam medical journal · 2021Article
- Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020Article
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4 authors.
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Abstract
introductionAlthough 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.
methodsPatients 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).
resultsPatients (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).
conclusionOnce-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 registrationClinicalTrials.gov, NCT02750410.
fundingEli Lilly and Company.
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