Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus treatment, Hospitalized patients
Brief 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.
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.
Interventions
DRUGMixtard 30:70 Novonordisk® twice daily
Premixed insulin twice daily before breakfast and before dinner
DRUGLantus® once daily and Apidra® before meals
Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner
Sponsors
Sanofi
Hospital Universitario Central de Asturias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in mean daily blood glucose concentration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and severity of hypoglycemia episodes | 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) | 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 | Participants will be followe for the duration of hospital stay, an expected average of 2 weeks | — |
Outcome results
None listed