A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea

CompletadoFase 3ClinicalTrials.gov

ID: NCT00960661Tipo: INTERVENTIONALInicio: 1 de sept de 2009Fin estimado: 1 de ago de 2012

Traducción no disponible, mostrando original

Resumen

The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.
Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
Have an HbA1C \> 7.0% and ≤ 10.0%.
Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.

Criterios de exclusión

Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have previously completed or been withdrawn from this study after enrollment.

Intervenciones

drug

exenatide

subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day

drug

insulin lispro

titrated based on pre-meal glucose level; three times a day

drug

Metformin

drug

Insulin/ Glargine

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Caba, Argentina

Research Site

Capital Federal, Argentina

Research Site

Ciudad Autonoma de Buenos Aire, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Corrientes, Argentina

Research Site

Rosario, Argentina

Research Site

San Rafael, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorEli Lilly and Company

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