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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Forst, Thomas Fahrbach, Jessie L. Povedano, Santiago Tofé Atisso, Charles Dungan, Kathleen M. González, José G. González Sealls, Whitney |
| Description | Author Affiliation: Dungan KM ( The Ohio State University, Columbus, OH, USA. Electronic address: kathleen.dungan@osumc.edu.); Povedano ST ( Clínica Juaneda, Endocrinología, Palma de Mallorca, Spain.); Forst T ( Profil Mainz GmbH & Co KG, Mainz, Germany.); González JG ( Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.); Atisso C ( Lilly Diabetes, Eli Lilly and Company, Indianapolis, IN, USA.); Sealls W ( Lilly Diabetes, Eli Lilly and Company, Indianapolis, IN, USA.); Fahrbach JL ( Lilly Diabetes, Eli Lilly and Company, Indianapolis, IN, USA.) |
| Abstract | BACKGROUND: Dulaglutide and liraglutide, both glucagon-like peptide-1 (GLP-1) receptor agonists, improve glycaemic control and reduce weight in patients with type 2 diabetes. In a head-to-head trial, we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients with uncontrolled type 2 diabetes. METHODS: We did a phase 3, randomised, open-label, parallel-group study at 62 sites in nine countries between June 20, 2012, and Nov 25, 2013. Patients with inadequately controlled type 2 diabetes receiving metformin (≥1500 mg/day), aged 18 years or older, with glycated haemoglobin (HbA1c) 7·0% or greater (≥53 mmol/mol) and 10·0% or lower (≤86 mmol/mol), and body-mass index 45 kg/m(2) or lower were randomly assigned to receive once-weekly dulaglutide (1·5 mg) or once-daily liraglutide (1·8 mg). Randomisation was done according to a computer-generated random sequence with an interactive voice response system. Participants and investigators were not masked to treatment allocation. The primary outcome was non-inferiority (margin 0·4%) of dulaglutide compared with liraglutide for change in HbA1c (least-squares mean change from baseline) at 26 weeks. Safety data were collected for a further 4 weeks' follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01624259. FINDINGS: We randomly assigned 599 patients to receive once-weekly dulaglutide (299 patients) or once-daily liraglutide (300 patients). 269 participants in each group completed treatment at week 26. Least-squares mean reduction in HbA1c was -1·42% (SE 0·05) in the dulaglutide group and -1·36% (0·05) in the liraglutide group. Mean treatment difference in HbA1c was -0·06% (95% CI -0·19 to 0·07, pnon-inferiority<0·0001) between the two groups. The most common gastrointestinal adverse events were nausea (61 [20%] in dulaglutide group vs 54 [18%] in liraglutide group), diarrhoea (36 [12%] vs 36 [12%]), dyspepsia (24 [8%] vs 18 [6%]), and vomiting (21 [7%] vs 25 [8%]), with similar rates of study or study drug discontinuation because of adverse events between the two groups (18 [6%] in each group). The hypoglycaemia rate was 0·34 (SE 1·44) and 0·52 (3·01) events per patient per year, respectively, and no severe hypoglycaemia was reported. INTERPRETATION: Once-weekly dulaglutide is non-inferior to once-daily liraglutide for least-squares mean reduction in HbA1c, with a similar safety and tolerability profile. FUNDING: Eli Lilly and Company. |
| ISSN | 01406736 |
| e-ISSN | 1474547X |
| Journal | The Lancet |
| Issue Number | 9951 |
| Volume Number | 384 |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2014-10-11 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | Open |
| Subject Keyword | Diabetes Mellitus, Type 2 Drug Therapy Glucagon-Like Peptide 1 Analogs & Derivatives Glucagon-Like Peptides Hypoglycemic Agents Administration & Dosage Immunoglobulin Fc Fragments Recombinant Fusion Proteins Analysis Of Variance Blood Glucose Metabolism Blood Drug Administration Schedule Fasting Adverse Effects Hemoglobin A, Glycosylated Liraglutide Metformin Therapeutic Use Clinical Trial, Phase III Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
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