Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3)
| Autor: | Federico Pérez Manghi, Santiago Tofe Povedano, Guillermo E. Umpierrez, Valeria Pechtner, Linda Shurzinske |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty Endocrinology Diabetes and Metabolism Recombinant Fusion Proteins Urology Glucagon-Like Peptides Type 2 diabetes law.invention Randomized controlled trial Double-Blind Method law Internal medicine Diabetes mellitus Internal Medicine medicine Humans Hypoglycemic Agents Glycemic Aged Advanced and Specialized Nursing Glycated Hemoglobin business.industry Body Weight Middle Aged medicine.disease Metformin Albiglutide Immunoglobulin Fc Fragments Endocrinology Treatment Outcome Diabetes Mellitus Type 2 Glycosylated hemoglobin A Dulaglutide Female business medicine.drug |
| Zdroj: | Diabetes care. 37(8) |
| ISSN: | 1935-5548 |
| Popis: | OBJECTIVE Compare the efficacy and safety of monotherapy with dulaglutide, a once-weekly GLP-1 receptor agonist, to metformin-treated patients with type 2 diabetes. The primary objective compared dulaglutide 1.5 mg and metformin on change from baseline glycosylated hemoglobin A1c (HbA1c) at 26 weeks. RESEARCH DESIGN AND METHODS This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin. Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period. RESULTS At 26 weeks, changes from baseline HbA1c (least squares [LS] mean ± SE) were: dulaglutide 1.5 mg, −0.78 ± 0.06% (−8.5 ± 0.70 mmol/mol); dulaglutide 0.75 mg, −0.71 ± 0.06% (−7.8 ± 0.70 mmol/mol); and metformin, −0.56 ± 0.06% (−6.1 ± 0.70 mmol/mol). Dulaglutide 1.5 and 0.75 mg were superior to metformin (LS mean difference): −0.22% (−2.4 mmol/mol) and −0.15% (−1.6 mmol/mol) (one-sided P < 0.025, both comparisons), respectively. Greater percentages reached HbA1c targets CONCLUSIONS Dulaglutide improves glycemic control and is well tolerated as monotherapy in patients with early stage type 2 diabetes. |
| Databáze: | OpenAIRE |
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