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

Phase 4

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Lantus® once daily and Apidra® before meals

• Registration Number: NCT02333851
• Lead Sponsor: Hospital Universitario Central de Asturias

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.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-12-20
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-05
• Last Update Submitted: 2015-01-05
• Study First Posted: 2015-01-07
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basal-bolus	Lantus® once daily and Apidra® before meals	'Lantus® once daily and Apidra® before meals

Primary Outcome Measures

Name	Time	Method
Differences in mean daily blood glucose concentration	Participants will be followe for the duration of hospital stay, an expected average of 2 weeks	Glucose concentration were measured in capillary blood 6 times a day, before and 2 hours after meals and daily mean calculated

Secondary Outcome Measures

Name	Time	Method
Total daily Insulin use in International Units per Kg of weight	Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Number and severity of hypoglycemia episodes	Participants will be followe for the duration of hospital stay, an expected average of 2 weeks	Frequency and severity of hypoglycemia episodes during all the stay in the hospital
Measures of dispersion of glycemia values (Glycemia variability)	Participants will be followe for the duration of hospital stay, an expected average of 2 weeks	Glycemia variability will be measured by standard deviation of blood glucose values, coefficient of variation and mean amplitude of glycemic excursions or MAGE.