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

Type 2 Diabetes Mellitus Clinical Trial

— PININ  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02333851
• Other study ID #: ENDOHUCA1
• Status: Terminated
• Phase: Phase 4
• First received: December 20, 2014
• Last updated: January 5, 2015
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: Hospital Universitario Central de Asturias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Mixtard 30:70 Novonordisk® twice daily
Premixed insulin twice daily before breakfast and before dinner
• Lantus® once daily and Apidra® before meals
Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Central de Asturias	Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
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	Yes
Secondary	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	No
Secondary	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	No