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Clinical Trial Details

Trial ID: L7322
Source ID: NCT02333851
Associated Drug: Mixtard 30:70 Novonordisk® Twice Daily
Title: Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)
Acronym: PININ
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Mixtard 30:70 Novonordisk® twice daily|DRUG: Lantus® once daily and Apidra® before meals
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: Hospital Universitario Central de Asturias | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 72
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-06
Completion Date: 2014-02
Results First Posted:
Last Update Posted: 2015-01-07
Locations:
URL: https://clinicaltrials.gov/show/NCT02333851