A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control

CompletadoFase 2ClinicalTrials.gov

ID: NCT00789035Tipo: INTERVENTIONALInicio: 1 de oct de 2008

Traducción no disponible, mostrando original

Resumen

The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Male and female patients with a diagnosis of type 2 diabetes mellitus
either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c \>7.0 to ≤10.0%
HbA1c \>7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
Age between 18 and 80 years
BMI less than 40 kg/m2
Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation

Criterios de exclusión

Myocardial infarction, stroke or TIA within 6 months prior to informed consent
Impaired hepatic function
Renal insufficiency or impaired renal function
Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
Chronic or clinically relevant acute infections
Current or chronic urogenital tract infection determined by medical history
History of clinically relevant allergy/hypersensitivity
Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
Treatment with anti obesity drugs
Current treatment with systemic steroids
Alcohol abuse
Treatment with an investigational drug within 2 months prior to informed consent
known intolerance to metformin
Dehydration
Unstable or acute CHF
Acute or chronic acidosis
Hereditary galactose intolerance
Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control

Intervenciones

drug

BI 10773

drug

placebo

drug

metformin

Ubicaciones

1245.9.54001 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.9.54002 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.9.54007 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.9.54008 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.9.54009 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.9.54010 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1245.9.54004 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

1245.9.54003 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

1245.9.54005 Boehringer Ingelheim Investigational Site

Salta, Argentina

1245.9.54006 Boehringer Ingelheim Investigational Site

Salta, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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