A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

CompletadoFase 3ClinicalTrials.gov

ID: NCT01422876Tipo: INTERVENTIONALInicio: 1 de ago de 2011Fin estimado: 1 de sept de 2013

Traducción no disponible, mostrando original

Resumen

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

Criterios de exclusión

Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent

Intervenciones

drug

high dose FDC

once daily

drug

BI 10773 high dose

once daily

drug

high dose FDC placebo

once daily

drug

low dose FDC placebo

once daily

drug

high dose FDC placebo

once daily

drug

high dose FDC placebo

once daily

drug

low dose FDC placebo

once daily

drug

low dose FDC placebo

once daily

drug

high dose BI 10773 placebo

once daily

drug

low dose FDC

once daily

drug

high dose FDC placebo

once daily

drug

BI 10773 low dose

low dose once daily

drug

high dose BI 10773 placebo

once daily

drug

high dose BI 10773 placebo

once daily

drug

linagliptin

once daily

drug

low dose FDC placebo

once daily

drug

linagliptin placebo

once daily

drug

BI 10773 low dose placebo

once daily

drug

linagliptin placebo

once daily

drug

low dose BI 10773 placebo

once daily

drug

linagliptin placebo

once daily

drug

high dose BI 10773 placebo

once daily

drug

BI 10773 low dose placebo

once daily

drug

low dose BI 10773 placebo

once daily

drug

linagliptin placebo

once daily

Ubicaciones

1275.1.54001 Boehringer Ingelheim Investigational Site

Caba, Argentina

1275.1.54005 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1275.1.54003 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

1275.1.54004 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

1275.1.54002 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

ColaboradorEli Lilly and Company

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