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

Hospital Universitario Central de Asturias

Status and phase: Terminated; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Lantus® once daily and Apidra® before meals; Drug: Mixtard 30:70 Novonordisk® twice daily

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02333851

ENDOHUCA1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Premixed insulin

Experimental group

Description:

Mixtard 30:70 Novonordisk® twice daily, before breakfast and before dinner.

Treatment:

Drug: Mixtard 30:70 Novonordisk® twice daily

Basal-bolus

Experimental group

Description:

'Lantus® once daily and Apidra® before meals

Treatment:

Drug: Lantus® once daily and Apidra® before meals