المؤلفون: Sue Penckofer, Jennifer Duffecy, Dan V. Mihailescu, Pamela Martyn-Nemeth, Laurie Quinn, Chang Park

المصدر: Trials, Vol 20, Iss 1, Pp 1-9 (2019)
Trials

مصطلحات موضوعية: Blood Glucose, Male, endocrine system diseases, medicine.medical_treatment, Medicine (miscellaneous), Pilot Projects, law.invention, Study Protocol, 0302 clinical medicine, Quality of life, Randomized controlled trial, law, immune system diseases, Insulin, Medicine, Pharmacology (medical), 030212 general & internal medicine, Young adult, Uncategorized, lcsh:R5-920, Fear, 3. Good health, Cognitive behavioral therapy, Type 1 diabetes, Female, lcsh:Medicine (General), Adult, medicine.medical_specialty, endocrine system, Adolescent, 030209 endocrinology & metabolism, Hypoglycemia, Diabetes Complications, Young Adult, 03 medical and health sciences, Diabetes mellitus, Humans, Hypoglycemic Agents, Glycemic, business.industry, Blood Glucose Self-Monitoring, Self-Management, Fear of hypoglycemia, nutritional and metabolic diseases, medicine.disease, Diabetes Mellitus, Type 1, Quality of Life, Physical therapy, Self Report, business

الوصف: Background In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level Methods/design A randomized controlled trial in 50 young adults aged 18 to 35 years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups. Discussion Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV. Trial registration ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fcfd237fb63f9a93fdd04b75f8e7180bTest

المؤلفون: Christel Hendrieckx, Kavita Kumareswaran, Sara Vogrin, D Jane Holmes-Walker, Jane Speight, Leon A. Bach, Elizabeth A. Davis, David N O'Neal, Martin de Bock, Mary B Abraham, Timothy W. Jones, Roland W. McCallum, Richard J MacIsaac, Steven Trawley, Vijaya Sundararajan, Morton G. Burt, Catriona M. Sims, Alicia J. Jenkins, Anthony C Keech, Joey Kaye, Peter G. Colman, Barbora Paldus, Stephen N Stranks, Neale Cohen, Glenn M. Ward, Sybil A McAuley, Melissa H Lee

المصدر: Diabetes Technology & Therapeutics. 23:460-466

مصطلحات موضوعية: Adult, Blood Glucose, Insulin pump, medicine.medical_specialty, endocrine system diseases, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, 030209 endocrinology & metabolism, Hypoglycemia, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Interquartile range, Internal medicine, Blood Glucose Self-Monitoring, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, Glycated Hemoglobin, Type 1 diabetes, business.industry, Australia, nutritional and metabolic diseases, medicine.disease, Confidence interval, Medical Laboratory Technology, Diabetes Mellitus, Type 1, business

الوصف: Background: This prerandomization analysis from the Australian HCL-Adult trial (registration number: ACTRN12617000520336) compared masked continuous glucose monitoring (CGM) metrics among adults using insulin pumps versus multiple daily injections (MDIs), who were all self-monitoring blood glucose (SMBG). Methods: Adults with type 1 diabetes, using an insulin pump or MDIs without real-time CGM (and entering a trial of closed-loop technology), were eligible. MDI users were given an insulin dosage calculator. All participants received diabetes and carbohydrate-counting education, then wore masked CGM sensors for 3 weeks. Ethics Approval: HREC-D 088/16 Results: Adults using MDIs (n = 61) versus pump (n = 59) did not differ by age, sex, diabetes duration, insulin total daily dose, or HbA1c at baseline. After education, median (interquartile range) CGM time in range (TIR) 70-180 mg/dL (3.9-10.0 mmol/L) was 54% (47, 62) for those using MDIs and 56% (48, 66) for those using pump (P = 0.40). All CGM metrics were equivalent for 24 h/day for MDI and pump users. Overnight, those using MDIs (vs. pump) spent more time with glucose

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::17f9d3a2957bfa505bb82c8a9ab60d0eTest
https://doi.org/10.1089/dia.2020.0589Test

المؤلفون: Ralph Ziegler, Winfried Keuthage, Tanja Wiedenmann, Stefan Kipper, Jörg Simon, Yasmin Kretzschmar, Thomas Danne, Matthias Axel Schweitzer

المصدر: Diabetes Technology & Therapeutics

مصطلحات موضوعية: Adult, Blood Glucose, Male, medicine.medical_specialty, endocrine system diseases, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Glycemic Control, Time-in-range, Insulin aspart, 03 medical and health sciences, Diabetes mellitus, 0302 clinical medicine, Endocrinology, Internal medicine, Humans, Hypoglycemic Agents, Insulin, Medicine, In patient, 030212 general & internal medicine, Continuous glucose monitoring, Insulin Aspart, Aged, Glycemic, Glycated Hemoglobin, Type 1 diabetes, business.industry, Blood Glucose Self-Monitoring, nutritional and metabolic diseases, Original Articles, Middle Aged, medicine.disease, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Female, business, Prandial insulin, medicine.drug

الوصف: Background: The GoBolus study investigated the real-world effectiveness of faster aspart in patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems. Methods: This 24-week, multicenter, single-arm, noninterventional study investigated adults with T1D (HbA1c, 7.5%–9.5%) receiving multiple daily injections (MDI) of insulin and using iscCGM within local healthcare settings for ≥6 months before switching to faster aspart at study start (week 0; baseline). Primary endpoint was HbA1c change from baseline to week 24. Exploratory endpoint was change in iscCGM metrics from baseline to week 24. Results: Overall, 243 patients were included (55.6% male), with mean age/diabetes duration, 49.9/18.8 years; mean HbA1c, 8.1%. By week 24, HbA1c had decreased by 0.19% (−2.1 mmol/mol, P 10.0 mmol/L, P = 0.026) and 20.4% to 17.9% (>13.9 mmol/L, P = 0.013), corresponding to 43.5 (P = 0.024) and 35.6 (P = 0.015) fewer minutes per day on average spent in these ranges, respectively; no change for time in hypoglycemia (

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ab485f466b4c72512e9b1a720ae6f03aTest
https://doi.org/10.1089/dia.2020.0360Test

المؤلفون: Addie L. Fortmann, William H. Polonsky

المصدر: Diabetes Technology & Therapeutics

مصطلحات موضوعية: Gerontology, Quality of life, Adult, Blood Glucose, endocrine system diseases, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Health outcomes, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Quality of life (healthcare), Diabetes mellitus, Outcome Assessment, Health Care, medicine, Humans, Hypoglycemic Agents, 030212 general & internal medicine, Continuous glucose monitoring, Type 1 diabetes, business.industry, Information Dissemination, Blood Glucose Self-Monitoring, nutritional and metabolic diseases, Original Articles, medicine.disease, Data sharing, Medical Laboratory Technology, Diabetes Mellitus, Type 1, business

الوصف: Background: To examine experiences with real-time continuous glucose monitoring (RT-CGM) data sharing and its impact on health-related outcomes. Methods: Adults with type 1 diabetes (T1D) (N = 302) using the Dexcom G5 Mobile or G6 RT-CGM system and sharing data with ≥1 family/friend follower completed a survey exploring their perceived value of data sharing, the impact of sharing on health and quality of life (QoL) outcomes, and how their chief follower (CF) used shared data to support their diabetes management. Regression analyses examined whether CF actions were linked to reported changes in health and QoL outcomes for the T1D adult. Results: The majority had lived with T1D >10 years, (76.5%), used RT-CGM >1 year (58.0%), and identified their spouse/partner as CF (51.9%). Data sharing reportedly contributed to improved hypoglycemic confidence (for 89.4% of respondents), improved overall well-being (54.3%), and reduced diabetes distress (36.1%). Benefits related to data sharing included fewer episodes of severe hypoglycemia (62.2%), better sleep (52.4%), and A1C improvement (47.3%). In particular, three positive CF actions were independent predictors of health and QoL benefits: celebrating success related to glycemic control, providing encouragement when glycemic control is challenging, and teamwork discussions about how CF should respond to out-of-range values. Conclusions: RT-CGM data sharing was associated with a range of health and QoL-related benefits. The occurrence of benefits was influenced by the collaborative management approaches taken by RT-CGM users and their data-sharing followers. Longitudinal trials are needed to determine the most effective patterns of collaborative data sharing, leading to their implementation into routine diabetes management.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3c4c9dc9b820b3398011f833f62388fTest
http://europepmc.org/articles/PMC7906862Test

المؤلفون: Anu Sharma, Owen Chan, Yu Kuei Lin, Ramkiran Gouripeddi, Danielle Groat, Julio C. Facelli, Man Hung, Michael W. Varner, Simon J. Fisher

المصدر: Diabetes Technol Ther

مصطلحات موضوعية: Adult, Blood Glucose, Male, endocrine system, Pediatrics, medicine.medical_specialty, endocrine system diseases, Endocrinology, Diabetes and Metabolism, MEDLINE, 030209 endocrinology & metabolism, Hypoglycemia, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, immune system diseases, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, In patient, 030212 general & internal medicine, Type 1 diabetes, business.industry, Continuous glucose monitoring, Blood Glucose Self-Monitoring, nutritional and metabolic diseases, Original Articles, Awareness, Middle Aged, medicine.disease, Medical Laboratory Technology, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Female, business

الوصف: Background: Continuous glucose monitoring (CGM) systems help reduce hypoglycemia in patients with type 1 diabetes (T1D). It remains unclear whether T1D patients with impaired awareness of hypoglycemia (IAH) continue to develop more hypoglycemia than those with normal hypoglycemia awareness (NA) despite CGM use. Materials and Methods: For this cross-sectional observational study, 99 T1D patients using real-time CGMs for ≥86% of time were recruited. Fifty and 49 patients were found to have NA and IAH (based on the Clarke questionnaire), respectively. Two-week CGM hypoglycemia data were collected. Results: IAH was associated with greater percentages of CGM values

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ab4289959d5c2e5935d6ebb1c46abfcbTest
https://doi.org/10.1089/dia.2020.0016Test

المؤلفون: Asirvatham Alwin Robert, Ruqayah AL-Shaikh, Ayman A. Al Hayek, Mohamed Abdulaziz Al Dawish, Mohammed Alhojele, Alshehri Hanan Hassan, Daniyah Sabri, Mohammed Alenazi, Shaza Aloufi

المصدر: Diabetes & Metabolic Syndrome: Clinical Research & Reviews. 14:2117-2122

مصطلحات موضوعية: Adult, Blood Glucose, Male, medicine.medical_specialty, Adolescent, endocrine system diseases, Diabetic ketoacidosis, Endocrinology, Diabetes and Metabolism, Saudi Arabia, 030209 endocrinology & metabolism, Logistic regression, Diabetic Ketoacidosis, Young Adult, 03 medical and health sciences, Hba1c level, 0302 clinical medicine, Risk Factors, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Retrospective analysis, Humans, 030212 general & internal medicine, Retrospective Studies, Glycated Hemoglobin, Type 1 diabetes, business.industry, Incidence, nutritional and metabolic diseases, Retrospective cohort study, General Medicine, Prognosis, medicine.disease, Diabetes Mellitus, Type 1, Female, business, Body mass index, Biomarkers, Follow-Up Studies

الوصف: To Investigate the factors associated with Diabetic Ketoacidosis (DKA) among patients with type 1 diabetes (T1D).This was a descriptive, retrospective study conducted among 1118 patients with T1D, at the Prince Sultan Military Medical City, Riyadh, Saudi Arabia. After, exclusion process, 336 patients were selected for analysis. Among these, 105 patients with T1D were hospitalized for DKA, whereas 231 patients without DKA were outpatients who visited the hospital for T1D follow-up treatment.Bivariate analysis between patients with DKA and those without DKA revealed significant relationships in terms of gender (p = 0.014), age (p = 0.0001), body mass index (BMI) (p = 0.017), hemoglobin A1c (HbA1c) (p = 0.0001), duration of diabetes (p = 0.001) and clinic appointments (p = 0.001). From the logistic regression analysis, it was clear that females (OR 1.88; p = 0.038) had a higher risk for DKA. As compared to the age group of ≥30 years, those in the age category of 20-29 years (OR 1.35; p = 0.001) and teenagers (OR 3.64; p = 0.001) faced a higher risk of having DKA episodes. Compared with patients having HbA1c levels8%, those showing HbA1c levels 8-9.9% (OR 1.77; p = 0.224) and ≥10% (OR 4.06; p = 0.003) revealed higher risk for DKA. Likewise, in comparison with the patients who were compliant to clinic appointments, those who were non-compliant to clinic appointments exhibited higher than six times the risk (OR 6.38; p = 0.0001) of being more prone to experiencing the DKA episodes.Patients with higher risk for DKA comprise, those having high HbA1c levels, longer period of diabetes duration, teenagers, female gender and non-compliant to clinic appointments.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8406f3e7cd01921874d949a45abbb678Test
https://doi.org/10.1016/j.dsx.2020.11.002Test

المؤلفون: Anuj Bhargava, Sarit Polsky, Béatrice Bois De Fer, Satish K. Garg, Bhaswati Mukherjee, James Thrasher, Suzanne Pierre, Irene Nowotny, Lionel Hovsepian

المصدر: Diabetes Technology & Therapeutics

مصطلحات موضوعية: Adult, Blood Glucose, Male, medicine.medical_specialty, endocrine system diseases, Continuous subcutaneous insulin infusion, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, 030209 endocrinology & metabolism, Follow-on product, Insulin aspart, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, 030212 general & internal medicine, Biosimilar Pharmaceuticals, Aged, Type 1 diabetes, Cross-Over Studies, business.industry, Biosimilar, Insulin, SAR341402, nutritional and metabolic diseases, Original Articles, Middle Aged, medicine.disease, Clinical trial, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Tolerability, Female, Open label, Infusion set occlusion, business, hormones, hormone substitutes, and hormone antagonists, medicine.drug

الوصف: Background: The aim was to assess the safety and tolerability of the insulin aspart biosimilar/follow-on product SAR341402 (100 U/mL solution; SAR-Asp) and originator insulin aspart (100 U/mL; NN-Asp; NovoLog®) self-administered through an insulin pump. Materials and Methods: This randomized, open-label, 2 × 4-week crossover study enrolled 45 adults with type 1 diabetes (T1D). Participants were randomized 1:1 to the treatment sequence SAR-Asp/NN-Asp or NN-Asp/SAR-Asp. The basal and prandial insulin doses were individually titrated. The primary outcome was the number of participants with at least one infusion set occlusion (infusion set change due to failure-to-correct hyperglycemia [plasma glucose ≥250 mg/dL] by insulin pump bolus) during the 4-week treatment. The main secondary outcome was the number of participants with at least one episode of unexplained hyperglycemia (regardless of correction by an insulin pump bolus without apparent material defect, medical, dietary, insulin dosing reason, or pump problem). Results: The number of participants reporting ≥1 infusion set occlusion were similar between treatments: 14/43 on SAR-Asp (33 events) and 12/43 on NN-Asp (24 events). The estimated difference in infusion set occlusion risk for SAR-Asp versus NN-Asp was 4.1% (95% confidence interval: −9.3% to 17.4%). The number of participants with ≥1 episode of unexplained hyperglycemia was similar between treatments (31/43 on SAR-Asp [154 events]; 32/43 on NN-Asp [175 events]). Hypoglycemia, treatment-emergent adverse events, hypersensitivity, and injection site reactions were similar between treatments. Conclusions: SAR-Asp and NN-Asp were well tolerated and had similar infusion set occlusions over a 4-week period in insulin pump users with T1D.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::457c99cdf26438c42310c6b5af626f3cTest
https://doi.org/10.1089/dia.2019.0446Test

المؤلفون: Ionut Bebu, Pearl G. Lee, Barbara H. Braffett, David S. Schade, William I. Sivitz, William H. Herman, Gayle M. Lorenzi, Victoria R. Trapani, Rodica Pop-Busui, John M. Lachin, Amisha Wallia, John I. Malone

المصدر: Diabetes Care

مصطلحات موضوعية: Adult, Blood Glucose, Male, Risk, Research design, medicine.medical_specialty, Pediatrics, Time Factors, Adolescent, endocrine system diseases, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Glycemic Control, Cohort Studies, Diabetes Complications, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Diabetes mellitus, Epidemiology, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Age of Onset, Epidemiology/Health Services Research, Child, Glycemic, Glycated Hemoglobin, Advanced and Specialized Nursing, Type 1 diabetes, business.industry, Proportional hazards model, Age Factors, nutritional and metabolic diseases, Middle Aged, medicine.disease, Diabetes Mellitus, Type 1, Child, Preschool, Cohort, Female, Observational study, business

الوصف: OBJECTIVE This epidemiological analysis of the pooled Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort describes the equivalence of a 1-percentage point increase in HbA1c (such as from 7% to 8%) and years of additional age or duration of type 1 diabetes (T1D) relative to the risk of complications. RESEARCH DESIGN AND METHODS Separate Cox proportional hazards models determined the number of additional years of age and/or duration of T1D that would result in the same increase in risk of microvascular (retinopathy, nephropathy, and neuropathy) and cardiovascular complications and mortality as a 1-percentage point increase in HbA1c. RESULTS The risk of any cardiovascular disease associated with a 1-percentage point increase in HbA1c was equivalent to the risk associated with 4.3 (95% CI 2.7–5.9) additional years of age or 5.6 (95% CI 2.7–6.5) additional years’ duration of T1D. The risk of estimated glomerular filtration rate CONCLUSIONS Our results help evaluate the impact of glycemia on advanced complications in a way that may be more interpretable to health care providers and individuals with T1D.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0046c08a0022081de6e5a0e7820a2096Test
https://doi.org/10.2337/dc20-0226Test

المؤلفون: Lina Merjaneh, Dana Dabelea, Jeanette M. Stafford, Santica M. Marcovina, Lawrence M. Dolan, Ralph B. D'Agostino, Jean M. Lawrence, Amy K. Mottl, Evgenia Gourgari, Amy S. Shah

المصدر: Pediatr Diabetes

مصطلحات موضوعية: Adult, Mean arterial pressure, medicine.medical_specialty, Adolescent, endocrine system diseases, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, Article, Cohort Studies, Young Adult, 03 medical and health sciences, Vascular Stiffness, 0302 clinical medicine, Insulin resistance, Diabetes mellitus, Internal medicine, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Age of Onset, Glycated Hemoglobin, Waist-to-height ratio, Type 1 diabetes, business.industry, Age Factors, nutritional and metabolic diseases, Cholesterol, LDL, medicine.disease, Obesity, United States, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Heart Disease Risk Factors, Pediatrics, Perinatology and Child Health, Arterial stiffness, Cardiology, Insulin Resistance, business, Diabetic Angiopathies

الوصف: Aim Our aim was to explore the relationship of Low-Density Lipoprotein Cholesterol (LDL-C) with subclinical cardiovascular disease (CVD) in youth with T1D and T2D. We hypothesized the association of LDL-C with elevated arterial stiffness (AS) would be partially accounted by the co-occurrence of other CVD factors. Method We included 1376 youth with T1D and 157 with T2D from the SEARCH study. CVD risk factors including LDL-C, waist to height ratio (WHtR), mean arterial pressure (MAP), HbA1c, albumin to creatinine ratio (ACR), and insulin sensitivity (IS) score were measured at both visits. At follow up, elevated carotid-femoral AS was defined as levels above 6.8 m/s. Multivariable logistic regression evaluated the odds of elevated AS as a function of the average CVD risk factors. Results At follow up, age was 18.0 ± 4.1 and 21.6 ± 3.5 years and duration of diabetes was 7.8 ± 1.9 and 7.7 ± 1.9 years in T1D and T2D, respectively. Elevated AS was found in 8.4% of T1D and 49.0% of T2D participants. Each SD increase in LDL-C was associated with 1.28 increased odds (95% CI 1.05-1.54, P = .013) of elevated AS in youth with T1D. The association was similar but not statistically significant in T2D. WHtR, IS, and MAP were associated with elevated AS in both groups. Adjustment for WHtR or IS attenuated to non-significance the relationship between LDL-C and AS in T1D. Conclusions Obesity and insulin resistance attenuate the association of high LDL-C with AS suggesting they partially account for the adverse effects of LDL-C on cardiovascular health in youth with T1D.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a0b9659bb75725f77237a38e93291744Test
https://doi.org/10.1111/pedi.13021Test

المؤلفون: Christoph Kapitza, Lenore Teichert, Irene Nowotny, Leszek Nosek, Wolfgang Schmider

المصدر: Diabetes Technology & Therapeutics

مصطلحات موضوعية: Adult, Blood Glucose, Male, Adolescent, endocrine system diseases, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Pharmacology, Insulin aspart, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Double-Blind Method, Pharmacokinetics, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, European Union, 030212 general & internal medicine, Biosimilar Pharmaceuticals, Aged, Type 1 diabetes, Cross-Over Studies, business.industry, Biosimilar, nutritional and metabolic diseases, Original Articles, Middle Aged, medicine.disease, United States, Phase i study, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Treatment Outcome, Pharmacodynamics, Phase I study, Glucose Clamp Technique, business, hormones, hormone substitutes, and hormone antagonists, medicine.drug

الوصف: Background: The objective of this study was to demonstrate the pharmacokinetic and pharmacodynamic similarity among SAR341402 insulin aspart biosimilar/follow-on product, United States-sourced insulin aspart (NovoLog®), and European Union-sourced insulin aspart (NovoRapid®). Materials and Methods: This was a single-center, randomized, double-blind, 3-treatment, 3-period, single-dose, crossover euglycemic study (NCT03202875) in 30 adult male subjects with type 1 diabetes (T1D). Subjects received 0.3 U/kg of each treatment under fasted conditions and underwent a 12-h euglycemic clamp technique to assess pharmacokinetic and pharmacodynamic activity for up to 12 h. Primary endpoints were area under the plasma insulin concentration–time curve from time zero to the last quantifiable concentration (INS-AUClast), and extrapolated to infinity (INS-AUCinf), maximum plasma insulin concentration (INS-Cmax), and the area under the body weight-standardized glucose infusion rate (GIR)–time curve from 0 to 12 hours (GIR-AUC0–12h) among the three treatments. GIRmax was the main secondary endpoint. Results: Of the 30 subjects randomized, 29 completed all 3 treatment periods. Pharmacokinetic and pharmacodynamic profiles were similar in all groups. The extent of exposure (INS-Cmax, INS-AUClast, and INS-AUCinf) and glucodynamic activity (GIR-AUC0–12h, GIRmax) was similar among the three treatments. The corresponding 90% confidence intervals for pairwise treatment ratios were completely contained within the limits of 80%–125%. SAR341402 was well tolerated. Conclusions: The present study demonstrated similar pharmacokinetic exposure profiles and glucodynamic potency among SAR341402, NovoLog, and NovoRapid in subjects with T1D, supporting further clinical evaluation of SAR341402 as a biosimilar/follow-on product.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::835b87dcd9ea09245d748d78b896ec2bTest
https://doi.org/10.1089/dia.2019.0351Test