Resumen

El propósito de este estudio es comparar LY2605541 e insulina isofánica humana en suspensión (NPH) utilizando las siguientes medidas en participantes tratados durante hasta 26 semanas: * Cambio en el control glucémico global de los participantes. * Tasa de episodios de hipoglucemia nocturna. * Número de participantes que alcanzan los objetivos glucémicos sin episodios de hipoglucemia nocturna. * Número total de episodios de hipoglucemia reportados.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin
Have been receiving 2 or more OAMs for at least 3 months prior to the study
Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, at screening
Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m\^2)
Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug

Criterios de exclusión

Have used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before screening
For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
Are taking, or have taken within the 90 days before screening, prescription or over-the-counter medications to promote weight loss
Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening
Have cardiac disease with functional status that is New York Heart Association Class III or IV
Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) \[177 millimoles per liter (mmol/L)\]
Have obvious clinical signs or symptoms of liver disease \[excluding nonalcoholic fatty liver disease (NAFLD)\], acute or chronic hepatitis, nonalcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening
Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Caba, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mar del Plata, Argentina

Comparación de LY2605541 versus insulina NPH humana como tratamiento de insulina basal en pacientes sin tratamiento previo con insulina con diabetes mellitus tipo 2 no controlados adecuadamente con 2 o más medicamentos antihiperglucemiantes orales: un estudio abierto, aleatorizado

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

LY2605541

Human Insulin NPH

Oral Antihyperglycemic Medications (OAM)

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Patrocinadores