Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Pilot study to compare the efficacy and safety of a premixed-insulin regimen (70% intermediate insulin and 30% regular insulin) to a basal-bolus insulin regimen (glargine once daily and glulisine before meals) hospitalized patients with type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Central de Asturias
• Collaborator: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Insulin, pork; isophane insulin, pork drug combination 30:70

Criteria

Inclusion Criteria:

• Previous diagnosis of type 2 diabetes with a blood glucose level on admission greater than 180 mg/dl and treated with diet, any combination of oral antidiabetics agents and/or insulin therapy

Exclusion Criteria:

• Patients with hyperglycemia without a previous diagnosis of diabetes

• Patients with acute hyperglycemic emergencies or with severe hyperglycemia treated with intravenous insulin infusion on admission

• Patients with acute or chronic kidney disease (serum creatinine greater than 2 mg/dl),

• Patients treated with corticosteroids

• Patients with history of severe or repeated hypoglycemic episodes

• Pregnant women

• Patients expected to require ICU admission or less than 3 days of hospital stay