Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide
| Autor: | Cristobal Morales, Ulrich Wendisch, Julio Rosenstock, George Dailey, Christopher H. Sorli, In Young Choi, Marcus Hompesch, Jahoon Kang, Kun-Ho Yoon, Michael E. Trautmann, John A. Stewart |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty Proline Endocrinology Diabetes and Metabolism Type 2 diabetes Placebo Gastroenterology Drug Administration Schedule Glucagon-Like Peptide-1 Receptor 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 Liraglutide business.industry Body Weight Middle Aged medicine.disease Metformin Treatment Outcome Tolerability Diabetes Mellitus Type 2 Drug Therapy Combination Female business medicine.drug |
| Zdroj: | Diabetes care. 42(9) |
| ISSN: | 1935-5548 |
| Popis: | OBJECTIVE To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy). RESEARCH DESIGN AND METHODS EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis). Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36). The primary efficacy end point was change in HbA1c from baseline to week 13. RESULTS From a baseline HbA1c of 7.7–8.0% (61.0–63.9 mmol/mol), all efpeglenatide doses ≥1 mg significantly reduced HbA1c versus placebo (placebo-adjusted least squares [LS] mean changes 0.6–1.2%, P < 0.05 for all) to a final HbA1c of 6.3–6.8% (45.4–50.6 mmol/mol); masked efpeglenatide 4 mg was noninferior to open-label liraglutide. Greater proportions treated with efpeglenatide ≥1 mg than placebo achieved HbA1c CONCLUSIONS Efpeglenatide once weekly led to significant reductions in HbA1c and weight, with a safety profile consistent with the GLP-1 RA class in patients with early T2D mostly on metformin monotherapy. |
| Databáze: | OpenAIRE |
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