Estudio de 24 Semanas, Aleatorizado, Doble Ciego, Controlado con Placebo para Evaluar la Seguridad y Eficacia de KRP-104 de Administración Diaria Única en Pacientes con Diabetes Mellitus Tipo 2 con Control Glucémico Inadecuado con Metformina en Monoterapia

CompletadoFase 2ClinicalTrials.gov

ID: NCT00995345Tipo: INTERVENTIONALInicio: 1 de oct de 2009Fin estimado: 1 de ene de 2011

Resumen

El propósito de este estudio es evaluar la seguridad y eficacia de KRP-104 sobre el control glucémico en pacientes con diabetes mellitus tipo 2 con control inadecuado con metformina en monoterapia.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Patients meeting the following criteria at the screening visit (Visit 1) will be eligible to participate in the trial:
Signed written informed consent;
Males and females 18 to 75 years of age, inclusive;
Females of childbearing potential must agree to use 2 adequate forms of barrier method contraception (eg, latex condom AND intrauterine device or a diaphragm) to avoid pregnancy while in the study;
On a stable dose (Greater than or equal to 10 weeks at the same dose) of metformin monotherapy (Less than or equal to 1500 mg/day or maximum tolerated dose), have an HbA1c greater than or equal to 7.0% and less than or equal to 10.5%; or
On metformin (less than or equal to 1500 mg/day) and 1 other antidiabetic agent (excluding TZD, insulin, or incretin therapies \[DPP-4 inhibitors and GLP-1 analogues\]) and have an HbA1c greater than or equal to 6.8% and less than or equal to 10.0%; or
Not on antidiabetic therapy (for at least 3 months prior to Visit 1) or have not been on a stable dose of metformin monotherapy for 10 weeks and have an HbA1c greater than or equal to 8.0% and less than or equal to 11.0%.

Criterios de exclusión

History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
History or presence of alcoholism or drug abuse within the 2 years prior to dosing;
Typical consumption of greater than or equal to 10 drinks of alcohol weekly;
Presence of any of the following conditions:
Significant renal impairment (glomerular filtration rate less than 60 mL/min);
Diabetic gastroparesis;
Active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
Fasting plasma glucose/blood glucose greater than 240 mg/dL (13.3 mmol/L) at Visit 3 (Week -2) (1 laboratory retest permitted);
Body mass index less than or equal to 20 kg/m2 and greater than or equal to 48 kg/m2;
Systolic blood pressure \<100 mmHg or \>160 mmHg and diastolic blood pressure \<50 mmHg or \>100 mmHg at Visit 3 (Note: medication to control blood pressure is allowed and should be optimized and stabilized prior to Visit 3);
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 X the upper limit of normal (ULN) (1 laboratory retest permitted);
Creatine phosphokinase (CPK) greater than 2 X the ULN (if not explained by muscular trauma or exercise) (1 laboratory retest permitted);
Serum creatinine \>1.5 mg/dL for males (132.6 μmol/L) and 1.4 mg/dL for females (123.8 μmol/L);
Fasting triglycerides (TG) \>600 mg/dL (6.78 mmol/L) at Visit 3 (Week -2) (Note: diet/exercise and lipid-lowering medication to control elevated TG is allowed; medications should be optimized and stabilized prior to Visit 3);
Treatment with pioglitazone or rosiglitazone within the previous 10 weeks (Visit 1); treatment with incretin therapy (DPP-4 inhibitors or GLP-1 analogues) within the previous 4 weeks (Visit 1);
Treatment with any type of insulin (ie, injected or inhaled) within the previous 3 months;
Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals

Intervenciones

drug

KRP-104

Tablet

drug

Placebo

Tablet

Ubicaciones

Buenos Aires, Argentina

Córdoba, Argentina

Loma Hermos Buenos Aires, Argentina

Patrocinadores

PrincipalActivX Biosciences, Inc.

ColaboradorKyorin Pharmaceutical Co.,Ltd

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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