ABSTRACT
BACKGROUND: Insulin degludec (IDeg) is a basal insulin with a stable, flat action profile and an even distribution of the blood glucose lowering effect over 24 hou rs. The terminal half-life of IDeg is about 25 hours, which reflects a mean prolongation by factor 2 compared to Insulin glargin (lGlar).This may enable for a more flexible daytime dosing versus up to now available basal insulins. METHOD: Two open, randomized, treat-to-target studies enrolled patients with type 1 diabetes (n =493) or type 2 diabetes (n = 687). Both phase 3 studies compared a daytime flexible dosing of IDeg (IDeg-flex) with IDeg at the evening meal (IDeg-evening) and IDler at a fixed daytime. In the IDeg-flex-group dosing intervals were predefined with variations between 8 and 40 hours. RESULTS: In patients with type 1 diabetes IDeg-flex proved to be non-inferior with respect to reduction of HbA1C (-0.40%) versus IDeg-evening (-0.41%) and IGlar (-0.58%) after 26 weeks. In addition, nocturnal hypoglycemic events were reduced by 40% (p < 0.01) with IDeg-flex versus IGlar. In patients with type 2 diabetes reduction of HbA1C with ID)eg-flex (-1.28%) was non-inferior to IDeg-evening (-1.07%) and IGlar (-1.26%), respectively, whereas rates for hypoglycemia were comparable. CONCLUSION: Patients with diabetes mellitus are enabled to dose a basal insulin flexibly when needed (minimum interval of 8 hours afterthe last injection is necessary). Impacts of this treatment option on quality of life and adherence and outcomes should be examined in observational trials.
Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Insulin, Long-Acting/administration & dosage , Adult , Blood Glucose/metabolism , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 2/blood , Drug Administration Schedule , Female , Glycated Hemoglobin/metabolism , Half-Life , Humans , Insulin Glargine/administration & dosage , Insulin Glargine/pharmacokinetics , Insulin, Long-Acting/pharmacokinetics , Male , Middle AgedABSTRACT
BACKGROUND: Insulin degludec (IDeg) is a basal insulin with a stable, flat action profile and an even distribution of the blood glucose lowering effect over 24 hou rs. The terminal half-life of IDeg is about 25 hours, which reflects a mean prolongation by factor 2 compared to Insulin glargin (lGlar).This may enable for a more flexible daytime dosing versus up to now available basal insulins. METHOD: Two open, randomized, treat-to-target studies enrolled patients with type 1 diabetes (n =493) or type 2 diabetes (n = 687). Both phase 3 studies compared a daytime flexible dosing of IDeg (IDeg-flex) with IDeg at the evening meal (IDeg-evening) and IDler at a fixed daytime. In the IDeg-flex-group dosing intervals were predefined with variations between 8 and 40 hours. RESULTS: In patients with type 1 diabetes IDeg-flex proved to be non-inferior with respect to reduction of HbA1C (-0.40%) versus IDeg-evening (-0.41%) and IGlar (-0.58%) after 26 weeks. In addition, nocturnal hypoglycemic events were reduced by 40% (p < 0.01) with IDeg-flex versus IGlar. In patients with type 2 diabetes reduction of HbA1C with ID)eg-flex (-1.28%) was non-inferior to IDeg-evening (-1.07%) and IGlar (-1.26%), respectively, whereas rates for hypoglycemia were comparable. CONCLUSION: Patients with diabetes mellitus are enabled to dose a basal insulin flexibly when needed (minimum interval of 8 hours after the last injection is necessary). Impacts of this treatment option on quality of life and adherence and outcomes should be examined in observational trials.
Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Insulin, Long-Acting/administration & dosage , Blood Glucose/metabolism , Clinical Trials, Phase III as Topic , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/diagnosis , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/diagnosis , Dose-Response Relationship, Drug , Drug Administration Schedule , Humans , Hypoglycemia/blood , Hypoglycemia/chemically induced , Hypoglycemia/prevention & control , Injections, Subcutaneous , Insulin, Long-Acting/pharmacokinetics , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: A new IOL implantation technique introduced in Germany since December 1995 is presented--the one-piece-plate-haptic silicone lens implantable with the Passport system. METHOD: From January to September 1996 in 291 patients after 3.2 mm clear cornea incision, capsulorhexis, phacoemulsification and implantation of an one-piece silicone posterior chamber lens with an implantation system was performed. The early post-operative results like visual outcome, astigmatism and complication rate are presented and compared to a group of 100 patients with implanted foldable three-piece silicone posterior chamber lenses. RESULTS AND DISCUSSION: The first post-operative day no statistically significant differences in visual outcome (mean: one-piece 0.71; three-piece 0.69), in absolute astigmatism (mean diopter 0.82 one-piece; 0.91 three-piece), in axial position and in complication rate were detectable. Differences of this new implantation technique compared to the conventional technique are discussed. CONCLUSION: The implantation of one-piece silicone lenses with the Passport system is a reliable and high quality alternative to conventional systems.
