FDA approves novel, faster-acting insulin lispro injection was reported by Regina Schaffer for HealioNews.com/Endocrinology, 16 June 2020.
Insulin lispro-aabc injection 100 U/mL and 200 U/mL (Lyumjev) is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the bloodstream and reduce HbA1c.
“Thanks to advances in glucose monitoring, the people with diabetes I treat in my practice are able to more clearly see the blood glucose spikes that happen naturally after a meal,” Mark Warren, MD, assistant professor of medicine, Campbell University of Osteopathic Medicine in North Carolina, said in the release. “With its fast onset, Lyumjev is a meaningful development for people who want their insulin to help manage their HbA1c and reduce those post-meal spikes.”
The approval of lispro-aabc injection was based on data from the phase 3 PRONTO-T1D and PRONTO-T2D studies, which compared lispro-aabc injection with insulin lispro injection 100 U/mL (Humalog) in adults with type 1 and type 2 diabetes, respectively, in a treat-to-target trial.
Lilly said the faster-acting insulin lispro will be included in the Lilly Insulin Value Program, allowing anyone with commercial insurance and those without insurance to fill their monthly prescription for $35. Once available, this savings option can be obtained by calling the Lilly Diabetes Solution Center at 833-808-1234, Monday through Friday, from 8 a.m. to 8 p.m. EST. The list price of Lyumjev will be the same as the list price for Humalog.
Read more: FDA approves novel, faster-acting insulin lispro injection
FreeStyle Libre 2 Cleared by FDA as iCGM was reported by Abbott and Jimmy McDermott and Albert Cai for diaTribe.org, 15 June 2020.
Abbott announced that the FDA cleared its next-generation FreeStyle Libre 2. The new integrated continuous glucose monitoring (iCGM) system will be available to adults and children ages four and older with diabetes. It is not yet known when the FreeStyle Libre 2 will officially launch in the United States, though Abbott says it will be in the “coming weeks.”
FreeStyle Libre 2 keeps the same “scanning” feature as the original FreeStyle Libre, and adds Bluetooth connectivity. This is important because it allows optional alerts for high and low blood glucose levels. Users that turn on these alerts will be able to get a notification on their reader or phone whenever their glucose reading goes above or below their specified ranges. The reader can make a sound and vibrate to tell the user that they are high or low, but will only show the actual blood glucose number and trend when the user scans the sensor.
FreeStyle Libre 2 has a 14-day wear, is factory-calibrated (no fingerstick calibrations required) with a one hour warm-up time, and is scanned with the reader device. The sensor is designed to be scanned with a mobile app, which is not yet available in the US. The self-applied sensor is the size of two-stacked quarters and is worn on the back of the upper arm. Importantly, FreeStyle Libre 2 will be offered at the same price as the original FreeStyle Libre.
Read more: FreeStyle Libre 2 Cleared by FDA as iCGM
Weekly Basal Insulin – The Wave of the Future? was reported from the ADA 2020 Highlights by diaTribe.org, 19 June 2020.
New types of insulin – once-weekly basal insulin injections – are being tested in clinical trials and may bring major developments to how people take insulin. In this session, Professor Philip Home, Dr. J. Hans DeVries, and Dr. Stefano Del Prato discussed the pros and cons and recent results from clinical trials of weekly basal insulin.
Weekly insulin could help people adhere to their prescribed therapy – but it will likely make dose titration and adjustments more challenging. One of the major challenges of weekly insulin is that people can’t modify insulin doses according to life disruptions (for example, sick days or increased physical activity).
Weekly Basal Insulin – The Wave of the Future?
Celiac disease ‘frequently’ asymptomatic in type 1 diabetes was written by Erin T. Welsh for HealioNews.com/endocrinology, 18 June 2020.
Celiac disease as a comorbidity of type 1 diabetes is often asymptomatic, and people with both diseases should closely monitor glucose levels during transition to a gluten-free diet, according to a study.
“Celiac disease is a disorder triggered by gluten that is frequently unrecognized and asymptomatic, especially in individuals with type 1 diabetes or other autoimmune conditions,” Farid Mahmud, MD, FRCPC, associate professor and clinician investigator in the division of endocrinology at the Hospital for Sick Children at the University of Toronto, told Healio. “A significant challenge faced by clinicians relates to absence of evidence to assess the benefits and harms of screening and treatment in asymptomatic persons, especially in the context of type 1 diabetes.”
“The higher rates of asymptomatic celiac disease observed in adults were surprising and reflective of lower rates of prior screening overall. … This may reflect a misperception of celiac disease as a condition exclusively seen during the pediatric period,” Mahmud said.
Read more: Celiac disease ‘frequently’ asymptomatic in type 1 diabetes
Non-insulin therapies and Type 1 Diabetes
REMOVAL study looked at the effects of metformin in people with type 1 diabetes (40 years of age or older), as reported on diaTribe.org on the 3rd day proceedings from ADA 2020.
Over three years, participants taking metformin saw the following benefits compared to those taking a placebo:
- A decrease in A1C of 0.13 percentage points
- A reduction in insulin dose by 1.2 units
- No change in the rate of minor or severe hypoglycemia
- From a baseline body weight of 193 lbs (87.7 kg), a weight loss of 2.6 lbs (1.17 kg)
- A reduction in LDL (“bad”) cholesterol by 0.13 mmol/L (5 mg/dL)
These data suggest that metformin did not have a clinically meaningful impact on glycemic management but may improve cardiovascular health in adults with type 1 diabetes. That’s disappointing, but something we’ve all wondered for years – now we know!
The LIRA-1 Study evaluated 24 weeks of GLP-1 agonist use in people with type 1 diabetes and excess weight and found that GLP-1 treatment:
- Did not have a statistically significant (meaningful) reduction in A1C compared to placebo.
- Reduced body weight by 13.4 lbs (6.1 kg) compared to placebo (from a baseline of about 205 lbs, or 93 kg).
- Increased gastrointestinal side effects (nausea, diarrhea).
- Did not decrease the amount of bolus insulin required but reduced basal insulin by about five to six units per day.
Researchers found that compared to placebo, the GLP-1 agonist did not decrease A1C but did decrease insulin dose and body weight. Researchers concluded that the GLP-1 agonist does not have a future as an add-on treatment to insulin in type 1 diabetes.
Compared to placebo in the Depict study, participants taking Farxiga (either 5mg or 10mg dose) experienced:
- Approximately a 0.45 percentage point drop in A1C by 24 weeks, and 0.2 to 0.3 percentage point decrease in A1C after 52 weeks
- A time in range increase of about 10% – a gain of almost two more hours of time in range per day
- A 10% decrease in both basal and bolus insulin
- A decrease in body weight of about 5.5 lbs (2.5 kg) with a 5mg dose, and about 7.7 lbs (3.5 kg) with a 10mg dose (from a baseline of 179 lbs, or 81 kg)
- An increased risk of genital infection and urinary tract infections
- No increase in hypoglycemia.
- An increased risk of DKA that rises with a larger dose
Dr. Chantal Mathieu concluded by sharing her “bottom line” on the use of SGLT-2 inhibitors in type 1 diabetes and preventing DKA.
Read more: Metformin, GLP-1 agonists, and SGLT-2 inhibitors in Type 1 Diabetes
Darn, i am glad I will not be trying a SGLT-2 Inhibitor anytime soon. Who needs a genital infection – ouch.
I am excited about the new Lilly fast acting insulin. The research who did the statics for the FDA application told me perhaps a year ago that she thought Lilly had a killer product on its hands. Seeing the graph of time for peak action, I think they have as well.