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▎The content team editor of WuXi AppTec today, the American Diabetes Association (ADA) journal Diabetes Care published the results of two important international clinical trials on long-acting insulin therapy.
The new insulin therapy icodec can safely treat type 2 diabetic patients and is as effective as insulin injected once a day.
For diabetic patients who need daily injections or even multiple injections of insulin, this means that it is expected to bring more convenient alternative therapies.
The scholar involved in the two studies, Dr.
Ildiko Lingvay of the University of Texas Southwestern Medical Center (UT Southwestern Medical Center) said, “Insulin has been around for 100 years and is the cornerstone of diabetes treatment.
But insulin treatment is not convenient.
It
can be done weekly.
The development of single-dose, safe and effective insulin is a huge advancement in this field.
"Image source: 123RF At present, insulin therapy is still a big challenge for millions of patients with type 2 diabetes worldwide.
The fear of injections and the inconvenience of injections make it difficult for many patients to start insulin therapy or have poor compliance.
In addition, many details of the patient's application of insulin will also affect the effectiveness and safety of insulin therapy, such as whether the dosage is accurate, whether the injection timing is appropriate, whether the blood glucose target adjustment is reasonable.
.
.
Therefore, the development of longer-acting insulin, reducing the frequency of injections, It may help patients to better perform insulin therapy, control blood sugar stably for a long time, and ultimately improve the prognosis of patients.
The weekly injection of insulin icodec was developed by Novo Nordisk, with a half-life of 196 hours, and can continuously and stably release insulin to meet the patient's basal insulin needs for a whole week.
A key phase 2 trial announced at the ADA 2020 annual meeting has shown that icodec and insulin glargine U100 have equivalent control of glycosylated hemoglobin (HbA1c) and fasting blood glucose in patients with poorly controlled insulin and insulin-naïve type 2 diabetes.
.
The two trials published this time further compared the effects of weekly injections of insulin icodec and once a day insulin glargine U100 and more ideal doses in insulin-naïve and treated patients.
Screenshot source: Diabetes Care's first study is a phase 2 randomized trial focusing on different dose strategies of icodec.
The study included a total of 205 patients with type 2 diabetes in 7 countries.
These patients have not received insulin treatment before, and HbA1c is still as high as 7%-10% under the treatment of oral hypoglycemic drugs.
Patients were randomized to receive 3 doses of icodec or insulin glargine U100, all of which were adjusted once a week.
▲Different insulin doses taken in each trial (data source: reference [1]; tabulation: new medical perspectives).
Through continuous blood glucose monitoring, the research team measured that these patients’ blood glucose reached the standard (70 mg) during the 15th and 16th weeks of treatment.
/dL–180 mg/dL) time ratio.
The results showed that this indicator of patients in each group was improved (76.
6% vs 57.
0% in group A; 83.
0% vs 55.
2% in group B; 80.
9% vs 51.
0% in group C; insulin glargine U100 75.
9% vs 55.
3%), And no unexpected safety signals were observed.
These data show that all icodec doses are effective in improving blood sugar control and are well tolerated.
The icodec dose A group achieves the best balance between blood sugar control and the risk of hypoglycemia.
Screenshot source: Diabetes Care's second randomized phase 2 trial evaluated the best way for patients with basal insulin therapy to transition to icodec once a week and insulin glargine U100 once a day.
The study included a total of 154 patients with type 2 diabetes in 5 countries who had poor blood glucose control (HbA1c 7%-10%) after receiving basal insulin therapy (10-50 units per day).
The patient was transferred 1:1:1 to receive icodec (double the starting dose, or the regular dose), or insulin glargine U100 for 16 weeks.
Through continuous blood glucose testing, in the 15th and 16th weeks of treatment, the time proportions of the three groups of blood glucose reaching the target (70 mg/dL–180 mg/dL) were 72.
9%, 66.
0%, and 65.
0%, respectively.
The average HbA1c levels of the three groups were respectively From 7.
9% of the study baseline to 7.
1% (high-dose icodec initiation of treatment) and 7.
4% (the other two groups), the incidence of adverse events and hypoglycemia was similar in the three groups.
Therefore, the research team believes that changing basal insulin to icodec once a week can bring patients effective blood sugar control and is well tolerated.
A higher initial dose of icodec can help patients reach their optimal blood sugar goals faster.
Image source: Dr.
123RFLingvay said, "These two studies have laid the foundation for the ongoing large-scale multi-center phase 3 clinical trial.
The current phase 3 trial is evaluating the efficacy of icodec once a week in patients with type 1 and type 2 diabetes. "I look forward to this innovative insulin going further and bringing better and newer insulin treatment options to diabetic patients as soon as possible! References [1] Harpreet S.
Bajaj, et al.
, (2021).
Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial.
Diabetes Care, DOI: https://doi.
org/10.
2337/dc20-2877[2] Ildiko Lingvay, et al.
, (2021).
A Randomized, Open-Label Comparison of Once-Weekly Insulin Icodec Titration Strategies Versus Once-Daily Insulin Glargine U100.
Diabetes Care, DOI: https://doi.
org/10.
2337/dc20-2878[3 ] Once-a-week insulin treatment could be game-changing for patients with diabetes.
Retrieved April 20, 2021, from The introduction of medical and health research progress is not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital for treatment.
The new insulin therapy icodec can safely treat type 2 diabetic patients and is as effective as insulin injected once a day.
For diabetic patients who need daily injections or even multiple injections of insulin, this means that it is expected to bring more convenient alternative therapies.
The scholar involved in the two studies, Dr.
Ildiko Lingvay of the University of Texas Southwestern Medical Center (UT Southwestern Medical Center) said, “Insulin has been around for 100 years and is the cornerstone of diabetes treatment.
But insulin treatment is not convenient.
It
can be done weekly.
The development of single-dose, safe and effective insulin is a huge advancement in this field.
"Image source: 123RF At present, insulin therapy is still a big challenge for millions of patients with type 2 diabetes worldwide.
The fear of injections and the inconvenience of injections make it difficult for many patients to start insulin therapy or have poor compliance.
In addition, many details of the patient's application of insulin will also affect the effectiveness and safety of insulin therapy, such as whether the dosage is accurate, whether the injection timing is appropriate, whether the blood glucose target adjustment is reasonable.
.
.
Therefore, the development of longer-acting insulin, reducing the frequency of injections, It may help patients to better perform insulin therapy, control blood sugar stably for a long time, and ultimately improve the prognosis of patients.
The weekly injection of insulin icodec was developed by Novo Nordisk, with a half-life of 196 hours, and can continuously and stably release insulin to meet the patient's basal insulin needs for a whole week.
A key phase 2 trial announced at the ADA 2020 annual meeting has shown that icodec and insulin glargine U100 have equivalent control of glycosylated hemoglobin (HbA1c) and fasting blood glucose in patients with poorly controlled insulin and insulin-naïve type 2 diabetes.
.
The two trials published this time further compared the effects of weekly injections of insulin icodec and once a day insulin glargine U100 and more ideal doses in insulin-naïve and treated patients.
Screenshot source: Diabetes Care's first study is a phase 2 randomized trial focusing on different dose strategies of icodec.
The study included a total of 205 patients with type 2 diabetes in 7 countries.
These patients have not received insulin treatment before, and HbA1c is still as high as 7%-10% under the treatment of oral hypoglycemic drugs.
Patients were randomized to receive 3 doses of icodec or insulin glargine U100, all of which were adjusted once a week.
▲Different insulin doses taken in each trial (data source: reference [1]; tabulation: new medical perspectives).
Through continuous blood glucose monitoring, the research team measured that these patients’ blood glucose reached the standard (70 mg) during the 15th and 16th weeks of treatment.
/dL–180 mg/dL) time ratio.
The results showed that this indicator of patients in each group was improved (76.
6% vs 57.
0% in group A; 83.
0% vs 55.
2% in group B; 80.
9% vs 51.
0% in group C; insulin glargine U100 75.
9% vs 55.
3%), And no unexpected safety signals were observed.
These data show that all icodec doses are effective in improving blood sugar control and are well tolerated.
The icodec dose A group achieves the best balance between blood sugar control and the risk of hypoglycemia.
Screenshot source: Diabetes Care's second randomized phase 2 trial evaluated the best way for patients with basal insulin therapy to transition to icodec once a week and insulin glargine U100 once a day.
The study included a total of 154 patients with type 2 diabetes in 5 countries who had poor blood glucose control (HbA1c 7%-10%) after receiving basal insulin therapy (10-50 units per day).
The patient was transferred 1:1:1 to receive icodec (double the starting dose, or the regular dose), or insulin glargine U100 for 16 weeks.
Through continuous blood glucose testing, in the 15th and 16th weeks of treatment, the time proportions of the three groups of blood glucose reaching the target (70 mg/dL–180 mg/dL) were 72.
9%, 66.
0%, and 65.
0%, respectively.
The average HbA1c levels of the three groups were respectively From 7.
9% of the study baseline to 7.
1% (high-dose icodec initiation of treatment) and 7.
4% (the other two groups), the incidence of adverse events and hypoglycemia was similar in the three groups.
Therefore, the research team believes that changing basal insulin to icodec once a week can bring patients effective blood sugar control and is well tolerated.
A higher initial dose of icodec can help patients reach their optimal blood sugar goals faster.
Image source: Dr.
123RFLingvay said, "These two studies have laid the foundation for the ongoing large-scale multi-center phase 3 clinical trial.
The current phase 3 trial is evaluating the efficacy of icodec once a week in patients with type 1 and type 2 diabetes. "I look forward to this innovative insulin going further and bringing better and newer insulin treatment options to diabetic patients as soon as possible! References [1] Harpreet S.
Bajaj, et al.
, (2021).
Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial.
Diabetes Care, DOI: https://doi.
org/10.
2337/dc20-2877[2] Ildiko Lingvay, et al.
, (2021).
A Randomized, Open-Label Comparison of Once-Weekly Insulin Icodec Titration Strategies Versus Once-Daily Insulin Glargine U100.
Diabetes Care, DOI: https://doi.
org/10.
2337/dc20-2878[3 ] Once-a-week insulin treatment could be game-changing for patients with diabetes.
Retrieved April 20, 2021, from The introduction of medical and health research progress is not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital for treatment.
