NCT02333851

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Hospital Universitario Central de Asturias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pilot, randomized, prospective, open-label study admitted to the Hospital with a previous diagnosis of type 2 diabetes or with a blood glucose level on admission greater than 180 mg/dl. Patients were randomized to receive a premixed human insulin formulation with 70% intermediate insulin plus 30% regular insulin (Mixtard 30®, Novo Nordisk) or a basal-bolus regimen with glargine once daily and glulisine before meals (Lantus® and Apidra®, Sanofi-Aventis). The primary outcome of the study was to determine differences in glycemic control between treatment groups as measured by mean daily blood glucose concentration during the hospital stay. Secondary objectives were to determine differences in the percentage of glucose measures between 80 and 180 mg/dl, frequency and severity of hypoglycemic events, total daily insulin use, length of hospital stay and glycemic viability between groups.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Mixtard 30:70 Novonordisk® twice daily	Premixed insulin twice daily before breakfast and before dinner
DRUG	Lantus® once daily and Apidra® before meals	Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2015-01-07
• Last updated: 2015-01-07