A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Up-titrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg

CompletadoFase 3ClinicalTrials.gov

ID: NCT00918138Tipo: INTERVENTIONALInicio: 1 de ago de 2009Fin estimado: 1 de may de 2010

Traducción no disponible, mostrando original

Resumen

The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 78 YearsSexo: ALL

Criterios de inclusión

Type 2 diabetes
years of age
Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
Fasting C-peptide: ≥1.0 ng/mL
FPG≥126 mg/dl obtained at the Day -7 visit
Body mass index (BMI): ≤ 40kg/m²
A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization

Criterios de exclusión

Women of childbearing potential unable or unwilling to use acceptable birth control
Women who are pregnant or breastfeeding
Significant cardiovascular history
Active liver disease
Renal impairment

Intervenciones

drug

Saxagliptin

Tablets, Oral, 5 mg, once daily, 4 weeks

drug

Metformin XR

Tablets, Oral, 1500 mg, once daily, 4 weeks

drug

Placebo matching Metformin XR

Tablets, Oral, 0 mg, once daily, 4 weeks

drug

Metformin XR

Tablets, Oral, 500 mg, once daily, 4 weeks

drug

Placebo matching Saxagliptin

Tablets, Oral, 0 mg, once daily, 4 weeks

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Patrocinadores

PrincipalAstraZeneca

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