Clinical trial NCT02333851: Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)
Official title: Comparison of Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus treatment
Hospitalized patients
Lead sponsor: Hospital Universitario Central de Asturias
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2015-01-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Differences in mean daily blood glucose concentration
timeFrame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Number and severity of hypoglycemia episodes
timeFrame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
measure: Measures of dispersion of glycemia values (Glycemia variability)
timeFrame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
measure: Total daily Insulin use in International Units per Kg of weight
timeFrame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Central de Asturias
name: Edelmiro Menéndez Torre
role: PRINCIPAL_INVESTIGATOR
References: