Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes

CompletadoFase 3ClinicalTrials.gov

ID: NCT00676338Tipo: INTERVENTIONALInicio: 1 de nov de 2008Fin estimado: 1 de ene de 2011

Traducción no disponible, mostrando original

Resumen

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

at least 18 years of age.
HbA1c between 7.1% and 11.0%, inclusive.
Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
have type 2 diabetes and are treated with diet and exercise alone.
Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).

Criterios de exclusión

Have history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
Have a history of renal transplantation or are currently receiving renal dialysis
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have history of severe GI disorder (e.g., gastroparesis)
Have a history of acute or chronic pancreatitis.
Have active proliferative retinopathy.
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 screening.
Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
Have had an organ transplant.
Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Are currently enrolled in any other clinical study.

Intervenciones

drug

exenatide once weekly

subcutaneous injection, 2mg, once weekly plus placebo oral once daily

drug

metformin

oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection

drug

sitagliptin

oral, 100 mg, daily plus placebo once weekly subcutaneous injection

drug

pioglitazone

oral, 30-45mg, daily plus placebo once weekly subcutaneous injection

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Mar del Plata, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorEli Lilly and Company

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