PMID- 34097244 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210721 IS - 1869-6953 (Print) IS - 1869-6961 (Electronic) IS - 1869-6961 (Linking) VI - 12 IP - 7 DP - 2021 Jul TI - The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES): Design and Baseline Characteristics. PG - 1929-1946 LID - 10.1007/s13300-021-01076-0 [doi] AB - INTRODUCTION: The TROPHIES observational study enrolled patients with type 2 diabetes mellitus (T2DM) initiating their first injectable treatment with the glucagon-like peptide 1 receptor agonists (GLP-1 RAs) dulaglutide or liraglutide. This manuscript focuses on the study design, baseline characteristics of the enrolled population, and factors associated with GLP-1 RA choice. METHODS: TROPHIES is a prospective, observational, 24-month study conducted in France, Germany, and Italy. Inclusion criteria include adult patients with T2DM, naive to injectable antihyperglycemic treatments, initiating dulaglutide or liraglutide per routine clinical practice. The primary outcome is the duration of treatment on dulaglutide or liraglutide without a significant treatment change. RESULTS: The analysis included 2181 patients (dulaglutide, 1130; liraglutide, 1051) (cutoff date May 15, 2019). The population was 56% male with mean [standard deviation (SD)] patient characteristics at baseline as follows: age, 59.2 (11.0) years; body mass index (BMI), 33.9 (6.6) kg/m(2); T2DM duration, 8.5 (6.9) years; and glycated hemoglobin (HbA1c), 8.2 (1.3)%. Between-cohort demographic and clinical characteristics were balanced. The mean (SD) HbA1c and BMI values for French, German, and Italian patients were, respectively, 8.6 (1.4)%, 8.2 (1.4)%, 8.0 (0.8)%; 33.3 (6.1) kg/m(2), 36.0 (7.2) kg/m(2), and 32.6 (5.9) kg/m(2). CONCLUSION: This study analysis at baseline provides an opportunity to evaluate between-country differences in baseline HbA1c, weight, macrovascular complications, and factors driving GLP-1 RA selection for patients with T2DM in daily practice. FAU - Garcia-Perez, Luis-Emilio AU - Garcia-Perez LE AD - Lilly, S.A., Avenida de La Industria, 30, 28108, Alcobendas, Spain. garcia_luis-emilio@lilly.com. FAU - Boye, Kristina S AU - Boye KS AD - Eli Lilly and Company, Indianapolis, IN, USA. FAU - Rosilio, Myriam AU - Rosilio M AD - Lilly France SAS, Neuilly Sur Seine, France. FAU - Jung, Heike AU - Jung H AD - Lilly Deutschland GmbH, Bad Homburg, Germany. FAU - Heitmann, Elke AU - Heitmann E AD - Lilly Deutschland GmbH, Bad Homburg, Germany. FAU - Norrbacka, Kirsi AU - Norrbacka K AD - Eli Lilly Finland, Helsinki, Finland. FAU - Federici, Marco Orsini AU - Federici MO AD - Eli Lilly and Company Italia SpA, Florence, Italy. FAU - Gentilella, Raffaella AU - Gentilella R AD - Eli Lilly and Company Italia SpA, Florence, Italy. FAU - Guerci, Bruno AU - Guerci B AD - Hopital Brabois Adultes, CHRU de Nancy and University of Lorraine, Nancy, France. FAU - Giorgino, Francesco AU - Giorgino F AD - University of Bari Aldo Moro, Bari, Italy. FAU - Aigner, Ulrich AU - Aigner U AD - Versdias GmbH, Sulzbach-Rosenberg, Germany. FAU - Sapin, Helene AU - Sapin H AD - Lilly France SAS, Neuilly Sur Seine, France. LA - eng GR - The study was funded by Eli Lilly and Company/Eli Lilly and Company/ PT - Journal Article DEP - 20210607 PL - United States TA - Diabetes Ther JT - Diabetes therapy : research, treatment and education of diabetes and related disorders JID - 101539025 PMC - PMC8266969 OAB - Dulaglutide and liraglutide are medications that can help people with type 2 diabetes mellitus (T2DM) to control their blood sugar levels. These medications may also reduce body weight and reduce the risk of major cardiovascular disease. Given these treatment effects, it is essential to know how they are used in everyday clinical practice. Therefore, a study is being performed in three countries (France, Germany, and Italy) in people with T2DM who had a first-ever injectable therapy for T2DM with dulaglutide or liraglutide. Here, we present the study design, the patient characteristics at the start of treatment, and the factors driving the choice of one or the other medication. We analyzed data from 2181 people with T2DM. On average, it was shown that they were middle-aged and obese. On average, these people were diagnosed with T2DM 8.5 years before the start of dulaglutide or liraglutide and had high blood sugar levels when these medications were started. The patient characteristics were slightly different between the three countries. Country-specific factors driving the choice of either medication were also identified. OABL- eng OTO - NOTNLM OT - Dulaglutide OT - Glucagon-like peptide 1 receptor agonists OT - Injectable therapy OT - Liraglutide OT - Observational study design OT - Patient characteristics OT - Type 2 diabetes EDAT- 2021/06/08 06:00 MHDA- 2021/06/08 06:01 PMCR- 2021/06/07 CRDT- 2021/06/07 12:34 PHST- 2021/03/15 00:00 [received] PHST- 2021/05/08 00:00 [accepted] PHST- 2021/06/08 06:00 [pubmed] PHST- 2021/06/08 06:01 [medline] PHST- 2021/06/07 12:34 [entrez] PHST- 2021/06/07 00:00 [pmc-release] AID - 10.1007/s13300-021-01076-0 [pii] AID - 1076 [pii] AID - 10.1007/s13300-021-01076-0 [doi] PST - ppublish SO - Diabetes Ther. 2021 Jul;12(7):1929-1946. doi: 10.1007/s13300-021-01076-0. Epub 2021 Jun 7.