Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study) (PININ)
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|ClinicalTrials.gov Identifier: NCT02333851|
Recruitment Status : Terminated (Safety reasons)
First Posted : January 7, 2015
Last Update Posted : January 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Mixtard 30:70 Novonordisk® twice daily Drug: Lantus® once daily and Apidra® before meals||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Premixed insulin
Mixtard 30:70 Novonordisk® twice daily, before breakfast and before dinner.
Drug: Mixtard 30:70 Novonordisk® twice daily
Premixed insulin twice daily before breakfast and before dinner
Other Name: Premixed 30:70 insulin two times a day
'Lantus® once daily and Apidra® before meals
Drug: Lantus® once daily and Apidra® before meals
Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner
Other Name: Basal bolus regimen
- Differences in mean daily blood glucose concentration [ Time Frame: 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
- Number and severity of hypoglycemia episodes [ Time Frame: 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) [ Time Frame: 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333851
|Principal Investigator:||Edelmiro Menéndez Torre||Hospital Universitario Central de Asturias|