Hyperglycemia Steroid-induced Clinical Trial
Official title:
Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy
Objective: to determine which regimen results in best glycemic control and safety profile,
expressed as glucose values within target range and occurrence of hypoglycemia. Secondary
objective is to compare patient satisfaction, clinical outcomes and toxicity.
Study design: Randomized open label cross-over study Study population: Patients ≥ 18 years,
who developed glucocorticoid induced hyperglycemia requiring initiation or adjustment of
antihyperglycemic agents in a previous chemotherapy cycle. Patient should have ≥2 cycles of
chemotherapy scheduled, with 3-10 consecutive days of ≥12,5mg prednisone-equivalent
glucocorticoid and a wash-out period of 4-38 days between each cycle.
Intervention: subjects will be treated by insulin regimen A and B in random order during two
consecutive cycles of chemotherapy. A) intermediate acting insulin 0.01 IU / mg
prednisone-equivalent / kg body weight once daily subcutaneous B) Short-acting insulin
according to sliding scale regimen, dose adjusted to current grade of hyperglycemia.
Main study parameters: Difference in fraction of blood glucose measurements (BGM) within
target range and occurrence of hypoglycemia.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Both study treatments are just a slight variation in regular care for
glucocorticoid induced hyperglycemia. Glycemic control is likely to improve due to
treatments and increased counselling. All subjects will receive both treatment regimens.
The burden consists of 16-32 extra BGMs over 2 x 4-10 days, wearing the glucose sensor, 1
venipuncture (if HbA1c and creatinin are not determined in routine laboratory within 3
months before start), and 1 randomization visit to the outpatient clinic. Potential risk is
the occurrence of hypoglycemia, as is present in any insulin therapy. The investigators
account for this risk by giving subjects dietary advice and education how to prevent,
recognize and treat hypoglycemia.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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