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

Phase 4TerminatedNCT02333851

Hospital Universitario Central de Asturias72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Mixtard 30:70 Novonordisk® twice dailyDRUG

Premixed insulin twice daily before breakfast and before dinner

Lantus® once daily and Apidra® before mealsDRUG

Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Differences in mean daily blood glucose concentration

Glucose concentration were measured in capillary blood 6 times a day, before and 2 hours after meals and daily mean calculated

Time frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes

Number and severity of hypoglycemia episodes

Frequency and severity of hypoglycemia episodes during all the stay in the hospital

Time frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks

Measures of dispersion of glycemia values (Glycemia variability)

Glycemia variability will be measured by standard deviation of blood glucose values, coefficient of variation and mean amplitude of glycemic excursions or MAGE.

Time frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks

Total daily Insulin use in International Units per Kg of weight

Time frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks

Data from ClinicalTrials.gov

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