Subcutaneous glargine insulin
DrugGlargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.
Other names: ATC code A10AE0, Lantus®, Abasaglar®
NCT Number: NCT02706119
Analyze the level of metabolic control achieved with a routine of regular insulin in the parenteral nutrition (PN) reservoir in addition to subcutaneous glargine insulin, versus only regular insulin in the PN reservoir.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Hospital Arquitecto Marcide-Naval, Ferrol, A Coruña, Spain
A pattern of basal insulin (using subcutaneous insulin glargine and regulating the stock as prandial), plus regular subcutaneous insulin as rescue, applied to total parenteral nutrition (TPN) should be as effective (glycemic control, variability) and safe (hypoglycemia) as the usual (regular insulin inside the TPN reservoir and subcutaneous insulin as rescue) in patients with type 2 diabetes critics.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Glargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.
Other names: ATC code A10AE0, Lantus®, Abasaglar®
Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
Other names: ATC code A10AB01, Actrapid®
Time frame: Before starting total parenteral nutrition
Basal glucose value before starting TPN (in mg/dL).
Time frame: Every 6h during 15 days of treatment
All blood glucose values (in mg/dL) every 6 hours during 15 days of TPN infusion.
Time frame: In days 1, 5 and 15 of treatment
Variation of average glucose (in mg/dL) compared with total dose of insulin (in mL), in days 1, 5 and 15 of treatment.
Time frame: During TPN treatment up to 15 days
Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 70 mg/dL during TPN treatment up to 15 days.
Time frame: During TPN treatment up to 15 days
Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 40 mg/dL during TPN treatment up to 15 days.
Time frame: Through study completion, an average of 15 days.
If the patient refers typical symptoms of hypoglycemia, a measure of blood glucose (in mg/mL) is immediately taken to check the level
Time frame: Through study completion, an average of 15 days.
If blood glucose <70 mg / dL, it is recorded whether or not the patient has symptoms consistent with hypoglycemia and how the episode terminates
Time frame: At day 15 of treatment
Standard deviation of blood glucose (SD): Expressed in milligrams per deciliter (in mg/dL).
Time frame: At day 15 of treatment
Coefficient of variation (CV): Expressed as a percentage (%). The ratio of the standard deviation of the blood glucoses values (in mg/dL) and the average blood glucose (in mg/dL), multiplied by 100.
Time frame: At day 15 of treatment
Investigator asses the occurrence of infectious complications in parenteral nutrition catheter. For the evaluation of the infections, temperature is collected daily and patient will perform a blood test weekly. It will be suspected infectious complication for any sudden onset of fever (usually "peaks"), with no other apparent source of infection.
Time frame: Every 6h during 15 days of treatment.
A determination above this value will be considered a complication: Hypertriglyceridemia ≥500 mg/dL
Time frame: Every 6h during 15 days of treatment.
A determination above this value will be considered a complication: Hypernatremia >150 mEq/L
Time frame: Every 6h during 15 days of treatment.
A determination below this value will be considered a complication: Hyponatremia <135 mEq/L
Time frame: Every 6h during 15 days of treatment.
A determination below this value will be considered a complication: Hypokalemia <3 mEq/L
Time frame: Every 6h during 15 days of treatment.
A determination below this value will be considered a complication: Hypomagnesemia <1.2 mg/dL
Time frame: Every 6h during 15 days of treatment.
A determination below this value will be considered a complication: Hypophosphatemia <2 mg/dL
Time frame: Every 6h during 15 days of treatment.
A determination above this value will be considered a complication: Hyperchloremia >120 mEq/L
Time frame: Every 6h during 15 days of treatment.
A determination below this value will be considered a complication: Hypocalcemia corrected calcium <8 mg/dL
Time frame: At day 7 and 15 of treatment
Alteration of liver function markers is defined as an elevation twice higher than normal limits, according to each laboratory, of two of some of the following parameters (when previously normal): GGT, GOT, GPT, FA or total bilirubin, at least 7 days after initiating TPN.
Time frame: At day 15 of treatment
All adverse events (AEs) are recorded in the case report data since the moment when the patient signs the informed consent. These events will be defined following the organ classification database of MedDRA system.
Fundación Pública Andaluza Progreso y Salud
Other
Subcutaneous Versus Intravenous Basal Insulin in Non-critical Hospitalized Diabetic Patients That Receive Total Parenteral Nutrition
Acronym: INSUPAR
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