- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333851
Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study) (PININ)
Comparison of Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Premixed insulin
Mixtard 30:70 Novonordisk® twice daily, before breakfast and before dinner.
|
Premixed insulin twice daily before breakfast and before dinner
Other Names:
|
Experimental: Basal-bolus
'Lantus® once daily and Apidra® before meals
|
Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
|
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.
|
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
Time Frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
|
Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Edelmiro Menéndez Torre, Hospital Universitario Central de Asturias
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENDOHUCA1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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