Hypoglycemia Risk Related to Double Dose Is Markedly Reduced with Basal Insulin Peglispro Versus Insulin Glargine in Patients with Type 2 Diabetes Mellitus in a Randomized Trial: IMAGINE 8
Autor: | Qianyi Zhang, Thomas Forst, Elaine Watkins, Parag Garhyan, Niels Porksen, Ludi Fan, Tim Heise, Leona Plum-Mörschel, Cynthia J. Harris |
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Jazyk: | angličtina |
Rok vydání: | 2017 |
Předmět: |
Blood Glucose
Male Endocrinology Diabetes and Metabolism medicine.medical_treatment Insulin Glargine Type 2 diabetes Polyethylene Glycols 0302 clinical medicine Endocrinology Medicine 030212 general & internal medicine Cross-Over Studies Insulin Lispro medicine.diagnostic_test Basal insulin peglispro (BIL) Middle Aged Medical Laboratory Technology Treatment Outcome Female medicine.drug Adult Risk medicine.medical_specialty Adolescent 030209 endocrinology & metabolism Hypoglycemia 03 medical and health sciences Young Adult Double-Blind Method Internal medicine Diabetes mellitus Insulin lispro Humans Hypoglycemic Agents Aged Blood glucose monitoring Dose-Response Relationship Drug business.industry Insulin glargine Insulin Type 2 Diabetes Mellitus Original Articles medicine.disease Diabetes Mellitus Type 2 Fasting blood glucose Insulin therapy business |
Zdroj: | Diabetes Technology & Therapeutics |
ISSN: | 1557-8593 1520-9156 |
Popis: | Background: Basal insulin peglispro (BIL) has a peripheral-to-hepatic distribution of action that resembles endogenous insulin and a prolonged duration of action with a flat pharmacokinetic/pharmacodynamic profile at steady state, characteristics that tend to reduce hypoglycemia risk compared to insulin glargine (GL). The primary objective was to demonstrate that clinically significant hypoglycemia (blood glucose ≤54 mg/dL [3.0 mmol/L] or symptoms of severe hypoglycemia) occurred less frequently within 84 h after a double dose (DD) of BIL than a DD of GL. Methods: This was a randomized, double-blind, two-period crossover study in patients with type 2 diabetes (T2D) previously treated with insulin (N = 68). For the first 3 weeks of each of the two crossover periods, patients received an individualized dose of BIL or GL once nightly (stable dose for 2 weeks/period). Then, during a 7-day inpatient stay with frequent blood glucose monitoring and standardized meals, one DD of study insulin was given. Glucose was infused if blood glucose was ≤54 mg/dL (3.0 mmol/L) or for symptoms of severe hypoglycemia. Results: Within 84 h after the DD, a significantly smaller proportion of patients experienced clinically significant hypoglycemia with BIL compared to GL (BIL, 6.6%; GL, 35.5%; odds ratio for BIL/GL 0.13 [95% confidence interval 0.04–0.39]; P |
Databáze: | OpenAIRE |
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