Comparison of trajectories of self-monitored glucose levels by hypoglycemia status over 52 weeks of treatment with insulin glargine or exenatide once weekly

2015 ◽  
Vol 8 (1) ◽  
pp. 148-157 ◽  
Author(s):  
Sanjoy K. Paul ◽  
Julius Agbeve ◽  
David Maggs ◽  
Jennie H. Best
Keyword(s):  
Insulin Glargine ◽  
Glucose Levels

The First Interchangeable Biosimilar Insulin: Insulin Glargine-yfgn

2021 ◽  
pp. 193229682110675
Author(s):  
Mark C. Matli ◽  
Andrea B. Wilson ◽  
Leah M. Rappsilber ◽  
Farron P. Sheffield ◽  
Miranda L. Farlow ◽  
...  
Keyword(s):  
Insulin Glargine ◽  
Price Competition ◽  
Market Competition ◽  
List Price ◽  
Access To Treatment ◽  
State Laws ◽  
Glucose Levels ◽  
Treatment Providers ◽  
Treatment Of Diabetes ◽  
In Suit

On March 23, 2020, all insulin products were reclassified as biologics instead of drugs under the Biological Price Competition and Innovation (BPCI) Act of 2009. This allows biosimilar insulin products to be manufactured when the patent expires for the reference biologic, sometimes called the originator or brand name product. A biosimilar product may not be substituted for the reference biologic at the pharmacy counter unless the biosimilar undergoes further switch trials to earn the designation as an interchangeable biosimilar. Insulin glargine-yfgn 100 units/mL is the first biosimilar insulin to attain interchangeable status with the reference insulin glargine. In the INSTRIDE 1 and INSTRIDE 2 trials, insulin glargine-yfgn has proven noninferiority regarding blood glucose reduction and adverse effect profile versus reference insulin glargine; even in the INSTRIDE 3 trial in which treatment of diabetes was switched between insulin glargine-yfgn and reference insulin glargine throughout the trial without statistically significant changes to glucose levels or adverse effects. Insulin glargine-yfgn may be substituted at the pharmacy counter without consultation with the prescriber, in accordance with state laws. In suit with other biosimilars, insulin glargine-yfgn’s list price is significantly lower than other insulin glargine products. This increases market competition leading to decreases in costs of other insulin glargine products. Many patients who could not previously afford insulin therapy may now have significantly improved access to treatment. Providers will need education to increase awareness of these new biosimilars and interchangeable biosimilar insulin products, cost benefits, and substitution allowances.

scholarly journals Nocturnal Glycemic Control with New Insulin Glargine 300 U/mL

2019 ◽  
Vol 2019 ◽  
pp. 1-6 ◽  
Author(s):  
Neng Chun Yu
Keyword(s):  
Blood Glucose ◽  
Insulin Glargine ◽  
Insulin Therapy ◽  
Real World ◽  
Statistical Significance ◽  
Treatment Phase ◽  
Glycemic Variability ◽  
The Real ◽  
Nocturnal Hypoglycemia ◽  
Glucose Levels

Insulin glargine 300 U/mL (Gla-300) is a new generation basal insulin product that has been demonstrated to have more stable pharmacokinetic and pharmacodynamic characteristics than insulin glargine 100 U/mL (Gla-100). To evaluate the real-world benefits of Gla-300 in reducing nocturnal fluctuations in blood glucose levels and nocturnal hypoglycemia, 10 Taiwanese patients using Gla-100 for insulin therapy were switched to Gla-300 and continuous glucose monitoring (CGM) was applied at nighttime to monitor changes to nocturnal glycemic variability parameters. Glycemic variability parameters measured to assess between- and within-night glycemic variability included mean 6-hour nocturnal (00:00–6:00 AM) glucose levels, standard deviation (SD), and coefficient of variance (CV) of mean nocturnal glucose levels and mean glucose excursion (MAGE). In this study, Gla-300 demonstrated comparable glycemic efficacy to Gla-100 and the potential to further reduce nocturnal hypoglycemia risk. Overall, nocturnal glycemic variability parameters measured during the Gla-300 treatment period were numerically smaller than those measured during the Gla-100 treatment phase although statistical significance was not reached. In terms of within-night glucose management, SD and CV values of mean nocturnal glucose levels were found to be statistically lower during the Gla-300 treatment phase than the Gla-100 treatment phase on nights individuals displayed normal blood glucose level readings at the beginning of the night. In summary, this study represents the first of its kind from Taiwan to evaluate the real-world clinical benefits of switching Taiwanese diabetes patients from Gla-100 to Gla-300 insulin therapy in reducing nighttime glucose variability by means of CGM.

scholarly journals Nocturnal Glucose Metabolism after Bedtime Injection of Insulin Glargine or Neutral Protamine Hagedorn Insulin in Patients with Type 2 Diabetes

2008 ◽  
Vol 93 (10) ◽  
pp. 3839-3846 ◽  
Author(s):  
Thomas Linn ◽  
Britta Fischer ◽  
Nedim Soydan ◽  
Michael Eckhard ◽  
Julia Ehl ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Glargine ◽  
Fasting Blood Glucose ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Nph Insulin ◽  
Double Blind ◽  
Glucose Levels ◽  
Neutral Protamine Hagedorn

Aims/Hypothesis: Insulin glargine is a long-acting human insulin analog often administered at bedtime to patients with type 2 diabetes. It reduces fasting blood glucose levels more efficiently and with less nocturnal hypoglycemic events compared with human neutral protamine Hagedorn (NPH) insulin. Therefore, bedtime injections of insulin glargine and NPH insulin were compared overnight and in the morning. Methods: In 10 type 2 diabetic patients, euglycemic clamps were performed, including [6,6′]2H2 glucose, to study the rate of disappearance (Rd) and endogenous production (EGP) of glucose during the night. On separate days at bedtime (2200 h), patients received a sc injection of insulin glargine, NPH insulin, or saline in a randomized, double-blind fashion. Results: Similar doses of both insulins had different metabolic profiles. NPH insulin had a greater effect on both Rd and EGP in the night compared with insulin glargine. By contrast, in the morning, insulin glargine was more effective, increasing Rd by 5.8 μmol/kg−1·min−1 (95% confidence interval 4.7–6.9) and reducing EGP −5.7 (−5.0 to −6.4) compared with NPH insulin. Nearly 80% of the glucose lowering effect in the morning was due to insulin glargine’s reduction of EGP. Its injection was associated with one-third lower morning glucagon levels compared with NPH insulin (P = 0.021). Conclusion/Interpretation: Nocturnal variations of EGP and Rd explain the reduced incidence of hypoglycemia and lower fasting glucose levels reported for insulin glargine compared with human NPH insulin.

scholarly journals Effect of Injection Site Cooling and Warming on Insulin Glargine Pharmacokinetics and Pharmacodynamics

2019 ◽  
Vol 13 (6) ◽  
pp. 1123-1128 ◽  
Author(s):  
Gabriel Bitton ◽  
Vital Rom ◽  
Uri Hadelsberg ◽  
Itamar Raz ◽  
Eda Cengiz ◽  
...  
Keyword(s):  
Insulin Glargine ◽  
Injection Site ◽  
Serum Insulin ◽  
Fasting Blood Glucose ◽  
Blood Glucose Control ◽  
Random Order ◽  
Serum Glucose ◽  
Glucose Levels ◽  
Long Acting ◽  
Control Study

Background: In type 1 diabetes (T1D), closed-loop systems provide excellent overnight fasting blood glucose control by adjusting the insulin infusion rate based on corresponding changes in sensor glucose levels. In patients on multiple daily insulin (MDI) injections, such control in overnight glucose levels has not been possible due to the inability to alter the absorption rate of long-acting insulin after injection. In this study, we tested the hypothesis that increases/decreases of fasting glucose levels could be achieved by cooling/warming the skin around the injection site, which would result in lower/higher Glargine absorption rates from its subcutaneous depot. Methods: Fourteen subjects with T1D (4 females; age 39.6 ± 16.7 years, HbA1c 7.8 ± 1.1%, BMI 25.4 ± 2.8 kg/m2) on MDI therapy underwent fasting pharmacokinetic and pharmacodynamic studies that started at ~8 am and lasted 240 min on 3 separate days in random order: a control day without warming or cooling of the injection site and two experimental days, one day with injection site warming and the other with cooling. Results: Cooling the skin around the glargine injection site reduced insulin concentrations by >40% ( P < .01 versus the warming study, P = .21 versus the control study), accompanied by a 55 mg/dL increase in serum glucose ( P < .01 versus the control study). Conversely, skin warming prevented the fall in serum insulin ( P = .2 versus the control study; P < .01 versus the cooling study), resulting in a 40 mg/dL reduction in serum glucose ( P < .001 versus the cooling study, P = .11 versus the control study). Conclusions: This proof of concept study has shown that cooling and warming the skin around the injection site provides a means to decrease and increase the rate of absorption and action of insulin glargine from its subcutaneous depot.

scholarly journals Desvenlafaxine-associated hyperglycemia: A case report and literature review

2020 ◽  
Vol 10 (3) ◽  
pp. 85-89
Author(s):  
Andrea D. Mekonnen ◽  
Aubrey A. Mills ◽  
Andrea L. Wilhite ◽  
Theresa K. Hoffman
Keyword(s):  
Blood Glucose ◽  
Insulin Glargine ◽  
Fasting Blood Glucose ◽  
Postprandial Blood Glucose ◽  
Drug Induced ◽  
Glucose Levels ◽  
Altered Glucose ◽  
Causative Factors ◽  
Glucose Dysregulation ◽  
Norepinephrine Reuptake Inhibitor

Abstract Desvenlafaxine is a potent selective serotonin and norepinephrine reuptake inhibitor used to treat depression and anxiety. Several antidepressants have been associated with drug-induced hyperglycemia, but currently there are no reports for desvenlafaxine. A case of suspected desvenlafaxine-induced hyperglycemia is presented involving a 59-year-old female with type 2 diabetes whose average blood glucose increased by 30 mg/dL for fasting blood glucose and 75 mg/dL for postprandial blood glucose 1 month after switching from venlafaxine to desvenlafaxine. Prior to starting desvenlafaxine, she was stable on metformin 1000 mg twice daily, insulin glargine 8 units daily, and dulaglutide 1.5 mg once weekly. Over the course of 3 months after desvenlafaxine initiation, insulin glargine was increased and insulin lispro was initiated as the patient refused alternative antidepressant therapy due to favorable improvements in anxiety and depression. No other cause for elevated blood glucose could be elucidated. The Naranjo scale resulted in a score of 3, indicating a possible cause for the adverse drug reaction. Antidepressants have been associated with glucose dysregulation. However, literature also demonstrates improved glycemic control in treated versus untreated depression. If altered glucose levels are noted, all potential causative factors should be evaluated and risks and benefits weighed to guide therapy.

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