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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Mixtard 30:70 Novonordisk® twice daily
* Drug: Lantus® once daily and Apidra® before meals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Premixed insulin<br>Mixtard 30:70 Novonordisk® twice daily, before breakfast and before dinner. | Drug: Mixtard 30:70 Novonordisk® twice daily<br>* Premixed insulin twice daily before breakfast and before dinner<br>* Other names: Premixed 30:70 insulin two times a day;|
| Experimental: Basal-bolus<br>'Lantus® once daily and Apidra® before meals | Drug: Lantus® once daily and Apidra® before meals<br>* Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner<br>* Other names: Basal bolus regimen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants will be followe for the duration of hospital stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of hypoglycemia episodes | Frequency and severity of hypoglycemia episodes during all the stay in the hospital | 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. | 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 |  | Participants will be followe for the duration of hospital stay, an expected average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus treatment, Hospitalized patients