Irene Romera1, Ignacio Conget2, Luis Alberto Vazquez3, Raffaella Gentilella4, Jeremie Lebrec5, Esteban Jódar6, Jesús Reviriego7. 1. Eli Lilly and Company, Avenida de la Industria 30, 28108 Alcobendas, Madrid, Spain. Electronic address: romera_irene@lilly.com. 2. Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Carrer de Villarroel 170, 08036 Barcelona, Spain. Electronic address: ICONGET@clinic.cat. 3. Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Av. de Valdecilla, s/n. 39008, Santander, Spain. 4. Jazz Healthcare Italy s.r.l., Italy. 5. HaaPACS GmbH, Bahnhofstr. N°19 C, 69198 Schriesheim, Germany. Electronic address: Lebrec_jeremie@network.lilly.com. 6. Hospital Universitario Quirón Salud, Calle Diego de Velázquez, 1, 28223 Pozuelo de Alarcón, Universidad Europea de Madrid, Madrid, Spain. 7. Eli Lilly and Company, Avenida de la Industria 30, 28108 Alcobendas, Madrid, Spain. Electronic address: reviriego_jesus@lilly.com.
Abstract
AIMS: To determine the early benefit:risk balance of dulaglutide versus insulin glargine in patients with type 2 diabetes mellitus (T2DM). METHODS: This post hoc analysis used data from a randomized, open-label study (AWARD-2; modified intention-to-treat group) in which suboptimally controlled metformin + glimepiride-treated patients received dulaglutide 1.5 mg (n = 273) or insulin glargine (n = 262). Two composite endpoints were used: for weeks 2-20, fasting serum glucose (FSG) <130 mg/dL (<7.2 mmol/L) without hypoglycemia (blood glucose ≤70 mg/dL [≤3.9 mmol/L] or severe hypoglycemia); at week 26, patients with glycated hemoglobin (HbA1c) <7.0% (<53.0 mmol/mol) or reduction from baseline ≥1.0% (≥10.9 mmol/mol), no hypoglycemia (as defined above) and no weight gain. Odds ratios (ORs) were generated using logistic regression analysis. RESULTS: The probability of reaching the FSG target without hypoglycemia was higher with dulaglutide than with insulin glargine at weeks 4 (OR 1.78; 95% confidence interval [CI] 1.22-2.60) and 8 (OR 1.69; 95% CI 1.15-2.48). The proportion of patients achieving the 26-week endpoint was higher with dulaglutide (37.4% vs. 10.3%; OR 5.28; 95% CI 3.28-8.48). CONCLUSIONS:Dulaglutide's balanced efficacy-to-safety profile compares favorably with that of insulin glargine and is apparent soon after treatment initiation and after 6 months of therapy.
RCT Entities:
AIMS: To determine the early benefit:risk balance of dulaglutide versus insulinglargine in patients with type 2 diabetes mellitus (T2DM). METHODS: This post hoc analysis used data from a randomized, open-label study (AWARD-2; modified intention-to-treat group) in which suboptimally controlled metformin + glimepiride-treated patients received dulaglutide 1.5 mg (n = 273) or insulinglargine (n = 262). Two composite endpoints were used: for weeks 2-20, fasting serum glucose (FSG) <130 mg/dL (<7.2 mmol/L) without hypoglycemia (blood glucose ≤70 mg/dL [≤3.9 mmol/L] or severe hypoglycemia); at week 26, patients with glycated hemoglobin (HbA1c) <7.0% (<53.0 mmol/mol) or reduction from baseline ≥1.0% (≥10.9 mmol/mol), no hypoglycemia (as defined above) and no weight gain. Odds ratios (ORs) were generated using logistic regression analysis. RESULTS: The probability of reaching the FSG target without hypoglycemia was higher with dulaglutide than with insulinglargine at weeks 4 (OR 1.78; 95% confidence interval [CI] 1.22-2.60) and 8 (OR 1.69; 95% CI 1.15-2.48). The proportion of patients achieving the 26-week endpoint was higher with dulaglutide (37.4% vs. 10.3%; OR 5.28; 95% CI 3.28-8.48). CONCLUSIONS: Dulaglutide's balanced efficacy-to-safety profile compares favorably with that of insulinglargine and is apparent soon after treatment initiation and after 6 months of therapy.