-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
*Only for medical professionals to read the reference super fast-acting insulin lispro is coming! Diabetes is a chronic disease that causes high blood sugar.
The International Diabetes Federation (IDF) estimates that the number of people with diabetes worldwide in 2019 is about 463 million, of which China is 116.
4 million, ranking first; and it is expected that the number of patients worldwide will increase to 700 million by 2030 [1].
Insulin is considered to be the most effective treatment for lowering hyperglycemia.
When diet, exercise or other hypoglycemic drugs cannot achieve adequate blood sugar control, insulin is suitable for the treatment of patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) .
According to the secretion pattern of physiological insulin, insulin is divided into basal insulin and prandial insulin.
The current mealtime insulin includes short-acting human insulin and fast-acting insulin analogs [2].
For prandial insulin, the speed of onset is very important-compared with short-acting human insulin, rapid-acting insulin analogues are more similar to the physiological prandial insulin secretion curve, which can better and faster control postprandial blood sugar [2].
However, the "super speed" of insulin is coming! On March 23, 2021, Eli Lilly announced a 26-week Phase III clinical study (18B-FH-) comparing the effectiveness and safety of super fast-acting insulin lispro Lyumjev and insulin lispro in adult patients with type 2 diabetes.
ITSE) reached the primary research endpoint.
The ITSE study of super fast-acting insulin significantly improves postprandial blood glucose fluctuations is a prospective, randomized, double-blind study comparing the effectiveness and safety of super fast-acting insulin lispro Lyumjev and insulin lispro combined with basal insulin in the treatment of adult type 2 diabetes (T2DM) patients , Multi-country, multi-center, Phase III positive controlled clinical study (ClinicalTrials.
gov, NCT03952143).The primary endpoint of the study was the combination of basal insulin (insulin degludec or insulin glargine) in adult T2DM patients.
The change of glycosylated hemoglobin (HbA1c) from baseline at week 26 after subcutaneous injection of super fast-acting insulin lispro 0-2 min before meals was not inferior Insulin lispro.
A total of 595 T2DM patients (including 481 Chinese patients) were included in this study, and 41 research centers around the world participated in the completion.
Studies have confirmed that at the 0.
4% non-inferiority threshold, the change in HbA1c of super fast-acting insulin lispro from baseline at 26 weeks is not inferior to that of insulin lispro [least squares (LS) mean difference (super fast-acting insulin lispro-lispro) Insulin) = 0.
07%, 95% confidence interval (CI): -0.
07% ~ 0.
21%], the primary endpoint was reached.
In terms of the key multiplicity adjustment purpose, compared with insulin lispro, super fast-acting insulin lispro can significantly improve the 1-hour postprandial blood glucose fluctuation (LS mean difference = -0.
8mmol/L, 95%CI: -1.
2mmol/L) ~ -0.
4mmol/L, p<0.
001) and 2 hours postprandial blood glucose fluctuation (LS mean difference = -1.
2mmol/L, 95% CI: -1.
7mmol/L ~ -0.
7mmol/L, p<0.
001).
In terms of safety, the safety profile of super fast-acting insulin lispro is similar to that of fast-acting insulin lispro.
The incidences of overall hypoglycemia, recorded symptomatic hypoglycemia and severe hypoglycemia in the two treatment groups are similar; adverse reactions and injection sites during the two treatment groups The reaction rate is similar.
Studies have confirmed that compared with traditional prandial insulin lispro, super fast-acting insulin lispro can provide T2DM patients with a prandial insulin that improves postprandial blood glucose fluctuations and is safe and well tolerated.
Super fast-acting insulin is closer to physiological prandial insulin secretion.
Existing prandial insulin still cannot match the speed of blood sugar increase after carbohydrate absorption in time.
Super fast-acting insulin lispro Lyumjev is a super fast-acting insulin analog developed by Eli Lilly.
It has the dual pharmacokinetic characteristics of fast onset and fast metabolism, and is closer to the physiological prandial insulin secretion. Compared with the existing fast-acting insulin analogue insulin lispro, super fast-acting insulin lispro significantly improves blood glucose fluctuations after a meal and brings more benefits.
Super fast-acting insulin lispro 100 units/mL has been approved for the first time in the world in March 2020, and has been marketed in the United States, the European Union, the United Kingdom, Japan and other countries.
It is suitable for improving the blood glucose control of adult diabetic patients.
Statement: 1.
Lyumjev is a drug under study and has not yet been approved in China.
2.
Eli Lilly does not recommend any unapproved drugs/indications.
References: [1] IDF Diabetes Atlas 2019[WWW].
[2] Mu Yiming, Zhu Dalong, Li Yan, et al.
Expert guidance on clinical application of fast-acting insulin analogues[J].
Drug Evaluation, 2016, 13(021) :13-17.
For submission/reprint/business cooperation, please contact: pengsanmei@yxj.
org.
cn
The International Diabetes Federation (IDF) estimates that the number of people with diabetes worldwide in 2019 is about 463 million, of which China is 116.
4 million, ranking first; and it is expected that the number of patients worldwide will increase to 700 million by 2030 [1].
Insulin is considered to be the most effective treatment for lowering hyperglycemia.
When diet, exercise or other hypoglycemic drugs cannot achieve adequate blood sugar control, insulin is suitable for the treatment of patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) .
According to the secretion pattern of physiological insulin, insulin is divided into basal insulin and prandial insulin.
The current mealtime insulin includes short-acting human insulin and fast-acting insulin analogs [2].
For prandial insulin, the speed of onset is very important-compared with short-acting human insulin, rapid-acting insulin analogues are more similar to the physiological prandial insulin secretion curve, which can better and faster control postprandial blood sugar [2].
However, the "super speed" of insulin is coming! On March 23, 2021, Eli Lilly announced a 26-week Phase III clinical study (18B-FH-) comparing the effectiveness and safety of super fast-acting insulin lispro Lyumjev and insulin lispro in adult patients with type 2 diabetes.
ITSE) reached the primary research endpoint.
The ITSE study of super fast-acting insulin significantly improves postprandial blood glucose fluctuations is a prospective, randomized, double-blind study comparing the effectiveness and safety of super fast-acting insulin lispro Lyumjev and insulin lispro combined with basal insulin in the treatment of adult type 2 diabetes (T2DM) patients , Multi-country, multi-center, Phase III positive controlled clinical study (ClinicalTrials.
gov, NCT03952143).The primary endpoint of the study was the combination of basal insulin (insulin degludec or insulin glargine) in adult T2DM patients.
The change of glycosylated hemoglobin (HbA1c) from baseline at week 26 after subcutaneous injection of super fast-acting insulin lispro 0-2 min before meals was not inferior Insulin lispro.
A total of 595 T2DM patients (including 481 Chinese patients) were included in this study, and 41 research centers around the world participated in the completion.
Studies have confirmed that at the 0.
4% non-inferiority threshold, the change in HbA1c of super fast-acting insulin lispro from baseline at 26 weeks is not inferior to that of insulin lispro [least squares (LS) mean difference (super fast-acting insulin lispro-lispro) Insulin) = 0.
07%, 95% confidence interval (CI): -0.
07% ~ 0.
21%], the primary endpoint was reached.
In terms of the key multiplicity adjustment purpose, compared with insulin lispro, super fast-acting insulin lispro can significantly improve the 1-hour postprandial blood glucose fluctuation (LS mean difference = -0.
8mmol/L, 95%CI: -1.
2mmol/L) ~ -0.
4mmol/L, p<0.
001) and 2 hours postprandial blood glucose fluctuation (LS mean difference = -1.
2mmol/L, 95% CI: -1.
7mmol/L ~ -0.
7mmol/L, p<0.
001).
In terms of safety, the safety profile of super fast-acting insulin lispro is similar to that of fast-acting insulin lispro.
The incidences of overall hypoglycemia, recorded symptomatic hypoglycemia and severe hypoglycemia in the two treatment groups are similar; adverse reactions and injection sites during the two treatment groups The reaction rate is similar.
Studies have confirmed that compared with traditional prandial insulin lispro, super fast-acting insulin lispro can provide T2DM patients with a prandial insulin that improves postprandial blood glucose fluctuations and is safe and well tolerated.
Super fast-acting insulin is closer to physiological prandial insulin secretion.
Existing prandial insulin still cannot match the speed of blood sugar increase after carbohydrate absorption in time.
Super fast-acting insulin lispro Lyumjev is a super fast-acting insulin analog developed by Eli Lilly.
It has the dual pharmacokinetic characteristics of fast onset and fast metabolism, and is closer to the physiological prandial insulin secretion. Compared with the existing fast-acting insulin analogue insulin lispro, super fast-acting insulin lispro significantly improves blood glucose fluctuations after a meal and brings more benefits.
Super fast-acting insulin lispro 100 units/mL has been approved for the first time in the world in March 2020, and has been marketed in the United States, the European Union, the United Kingdom, Japan and other countries.
It is suitable for improving the blood glucose control of adult diabetic patients.
Statement: 1.
Lyumjev is a drug under study and has not yet been approved in China.
2.
Eli Lilly does not recommend any unapproved drugs/indications.
References: [1] IDF Diabetes Atlas 2019[WWW].
[2] Mu Yiming, Zhu Dalong, Li Yan, et al.
Expert guidance on clinical application of fast-acting insulin analogues[J].
Drug Evaluation, 2016, 13(021) :13-17.
For submission/reprint/business cooperation, please contact: pengsanmei@yxj.
org.
cn
