A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 404173 Administered Once Weekly to Obese Patients With Type 2 Diabetes Mellitus Being Treated With Metformin or Metformin Plus Sulfonylurea

CompletadoFase 2ClinicalTrials.gov

ID: NCT01918865Tipo: INTERVENTIONALInicio: 1 de ago de 2013Fin estimado: 1 de feb de 2015

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Body mass index (BMI) \>/= 27 kg/m2
HbA1c between 7.5% and 10.5% (inclusive)
C-Peptide (fasting) greater than or equal to 500 pmol/L
On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for \>/= 3 months prior to screening, and remain on stable dose throughout the study
Agree to conduct home-based (fasted) blood glucose testing as directed

Criterios de exclusión

Clinically significant abnormalities in medical history or physical exam
Serum creatinine \> ULN at Screening
Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT or AST \> 1.5x ULN at Screening
History of renal transplantation or renal dialysis
GFR \< 60 mL/min at Screening
History of diabetic ketoacidosis
History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
Allergy to sulfur containing drugs
Treatment with other drugs or medications not allowed per study specific Disallowed Concomitant Medicines
Any other significant illness or condition that may interfere with the patient participating or completing the study
Inability or unwillingness to comply with protocol or study procedures

Intervenciones

drug

ISIS-PTP1BRx

drug

Placebo

drug

daily OAD (metformin and/or sulfonylurea)

Ubicaciones

Isis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Isis Investigative Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalIonis Pharmaceuticals, Inc.

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