Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications

CompletadoFase 3ClinicalTrials.gov

ID: NCT01029886Tipo: INTERVENTIONALInicio: 1 de ene de 2010Fin estimado: 1 de abr de 2011

Traducción no disponible, mostrando original

Resumen

No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosed with type 2 diabetes
Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start 7.1% and 11.0%, inclusive
Have a body mass index (BMI) ≤45 kg/m\^2
Have been treated with lifestyle modification (diet and exercise) and with one of the following single oral antidiabetic agents (OADs) or combinations of OADs administered at maximum tolerated dose:
metformin
SU
metformin plus an SU
metformin plus pioglitazone

Criterios de exclusión

Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the excipients contained in these agents
If taking metformin and have a contraindication to metformin use
Have been treated within 8 weeks of study start with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route
Have been treated with drugs that promote weight loss (e.g., Xenical® \[orlistat\], Meridia® \[sibutramine\], Acomplia® \[rimonabant\], Acutrim® \[phenylpropanolamine\], or similar over-the-counter medications) within 3 months of study start
Have taken any of the following excluded medications for more than 1 week within the 3 months prior to study start, or have taken any of the following excluded medications within 1 month prior to study start:
Insulin
Alpha-glucosidase inhibitors (e.g., Glyser® \[miglitol\] or Precose® \[acarbose\])
Meglitinides (e.g., Prandin® \[repaglinide\] or Starlix® \[nateglinide\])
Avandia® (rosiglitazone)
Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ \[sitagliptin\], Galvus® \[vildagliptin\], Onglyza™ \[saxagliptin\])
Symlin® (pramlintide acetate)
Have donated blood within 30 days prior to study start or have had a blood transfusion or severe blood loss within 3 months prior to study start
Have at any time, including a clinical trial, taken exenatide once weekly, exenatide twice daily, liraglutide, or any other GLP-1 receptor agonist or GLP-1 analog
Are currently enrolled in, or discontinued within the last 3 months or longer if required by local guidelines, from a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have previously been screen-failed from this study for any reason
If a subject discontinues metformin, sulfonylurea, or pioglitazone prior to screening, the subject can be included if they discontinued the medication (whether alone or as component of combined medication) according to a specific schedule.

Intervenciones

drug

exenatide once weekly

subcutaneous injection, 2mg, once weekly

drug

liraglutide

subcutaneous injection, forced titration to 1.8mg, once daily

Ubicaciones

Research Site

Buenos Aires, Argentina

Research site

Mendoza, Argentina

Research Site

Rosario, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorEli Lilly and Company

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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