Efficacy and Safety of Taspoglutide Monotherapy in Drug-Naive Type 2 Diabetic Patients After 24 Weeks of Treatment
| Autor: | Itamar Raz, Laurence Durrwell, John Hoekstra, Mark Boldrin, Raffaella Balena, Mark Kipnes, Vivian Fonseca |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty Adolescent Endocrinology Diabetes and Metabolism Phases of clinical research Taspoglutide Type 2 diabetes Placebo Gastroenterology law.invention Young Adult Double-Blind Method Randomized controlled trial law Internal medicine Multicenter trial Internal Medicine medicine Humans Hypoglycemic Agents Adverse effect Original Research Aged Glycemic Aged 80 and over Glycated Hemoglobin Advanced and Specialized Nursing business.industry Body Weight Clinical Care/Education/Nutrition/Psychosocial Research Middle Aged medicine.disease Surgery Treatment Outcome Diabetes Mellitus Type 2 Female Peptides business |
| Zdroj: | Diabetes Care |
| ISSN: | 1935-5548 0149-5992 |
| DOI: | 10.2337/dc11-1942 |
| Popis: | OBJECTIVE To evaluate the efficacy and safety of taspoglutide monotherapy in drug-naive patients with type 2 diabetes inadequately controlled. RESEARCH DESIGN AND METHODS In this 24-week double-blind, placebo-controlled, multicenter trial, 373 patients with type 2 diabetes naive to antihyperglycemic medication were randomized to weekly subcutaneous taspoglutide 10 or 20 mg or placebo. RESULTS HbA1c reductions from baseline were greater with taspoglutide 10 and 20 mg than placebo (least squares mean [SE] changes: –1.01% [0.07], –1.18% [0.06], and –0.09% [0.07], respectively; both P < 0.0001 vs. placebo). Decreases in bodyweight were greater with taspoglutide 10 mg (–1.45 kg [0.32]) and with 20 mg (–2.25 kg [0.30]) than placebo (–1.23 kg [0.31]; P = 0.61 and P = 0.02 for taspoglutide 10 and 20 mg vs. placebo, respectively). Gastrointestinal adverse events and injection site reactions were more common with taspoglutide than placebo. CONCLUSIONS In drug-naive patients, once-weekly taspoglutide improved glycemic control, reduced body weight, and was generally well tolerated. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|