User login
Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.
In addition, degludec achieved those results without additional adverse events.
"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).
Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.
Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.
The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.
They were randomized to one of four groups:
• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).
• Insulin degludec once daily (600 nmol/mL formulation).
• Insulin degludec once daily (900 nmol/mL formulation).
• Insulin glargine once daily (600 nmol/mL formulation).
All four drug regimens were given in combination with metformin.
Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.
After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.
Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.
Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.
Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.
Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.
Patients with diabetes mellitus spend more than 2 hours a day on self care, which includes glucose monitoring, sorting medications, deciding about insulin dosing, and dietary decisions. Therefore, a recent trend ... has been the introduction of long-acting drugs that could be administered less than daily to improve adherence while minimizing side effects.
Doses given three times a week might improve adherence, improve glycemic control without an increase in hypoglycemia, and cause less disruption to the patient’s lifestyle.
Future trials and clinical practice in diabetes will involve combination of several agents from multiple classes, chosen for efficacy, safety, and convenience. Drugs for weekly administration schedules will probably become available in the future, including long-acting exenatide and insulin degludec.
As therapy for type 2 diabetes has increased in complexity, advances in several fields have enabled longer life span for those with the disease. This extension has resulted in the observation and reporting of cancers in patients with type 2 diabetes. Although the evidence is much debated, high circulating concentrations of insulin might increase the risk of neoplasia. Several observational studies and many editorials have addressed the complexity of the data, which reiterates the importance of keeping this issue on the radar.
It is extremely worthwhile to remember that therapeutic lifestyle changes are inexpensive and favorable on a risk-benefit basis and need persistent re-emphasis, as is being done for the financial benefits accruing to patients from their employer and insurance by doing so. This option is not often thought about but needs resurrection, even as the numbers of long-acting drugs for type 2 diabetes increase.
These comments are excerpted from an accompanying editorial by Dr. Yogish C Kudva and Dr. Ananda Basu of the department of endocrinology, Mayo Clinic College of Medicine, Rochester, Minn. (Lancet 2011 [doi:10.1016/S0140-6736(11)60097-4). Dr. Kudva and Dr. Basu declared that they have no financial disclosures.
Patients with diabetes mellitus spend more than 2 hours a day on self care, which includes glucose monitoring, sorting medications, deciding about insulin dosing, and dietary decisions. Therefore, a recent trend ... has been the introduction of long-acting drugs that could be administered less than daily to improve adherence while minimizing side effects.
Doses given three times a week might improve adherence, improve glycemic control without an increase in hypoglycemia, and cause less disruption to the patient’s lifestyle.
Future trials and clinical practice in diabetes will involve combination of several agents from multiple classes, chosen for efficacy, safety, and convenience. Drugs for weekly administration schedules will probably become available in the future, including long-acting exenatide and insulin degludec.
As therapy for type 2 diabetes has increased in complexity, advances in several fields have enabled longer life span for those with the disease. This extension has resulted in the observation and reporting of cancers in patients with type 2 diabetes. Although the evidence is much debated, high circulating concentrations of insulin might increase the risk of neoplasia. Several observational studies and many editorials have addressed the complexity of the data, which reiterates the importance of keeping this issue on the radar.
It is extremely worthwhile to remember that therapeutic lifestyle changes are inexpensive and favorable on a risk-benefit basis and need persistent re-emphasis, as is being done for the financial benefits accruing to patients from their employer and insurance by doing so. This option is not often thought about but needs resurrection, even as the numbers of long-acting drugs for type 2 diabetes increase.
These comments are excerpted from an accompanying editorial by Dr. Yogish C Kudva and Dr. Ananda Basu of the department of endocrinology, Mayo Clinic College of Medicine, Rochester, Minn. (Lancet 2011 [doi:10.1016/S0140-6736(11)60097-4). Dr. Kudva and Dr. Basu declared that they have no financial disclosures.
Patients with diabetes mellitus spend more than 2 hours a day on self care, which includes glucose monitoring, sorting medications, deciding about insulin dosing, and dietary decisions. Therefore, a recent trend ... has been the introduction of long-acting drugs that could be administered less than daily to improve adherence while minimizing side effects.
Doses given three times a week might improve adherence, improve glycemic control without an increase in hypoglycemia, and cause less disruption to the patient’s lifestyle.
Future trials and clinical practice in diabetes will involve combination of several agents from multiple classes, chosen for efficacy, safety, and convenience. Drugs for weekly administration schedules will probably become available in the future, including long-acting exenatide and insulin degludec.
As therapy for type 2 diabetes has increased in complexity, advances in several fields have enabled longer life span for those with the disease. This extension has resulted in the observation and reporting of cancers in patients with type 2 diabetes. Although the evidence is much debated, high circulating concentrations of insulin might increase the risk of neoplasia. Several observational studies and many editorials have addressed the complexity of the data, which reiterates the importance of keeping this issue on the radar.
It is extremely worthwhile to remember that therapeutic lifestyle changes are inexpensive and favorable on a risk-benefit basis and need persistent re-emphasis, as is being done for the financial benefits accruing to patients from their employer and insurance by doing so. This option is not often thought about but needs resurrection, even as the numbers of long-acting drugs for type 2 diabetes increase.
These comments are excerpted from an accompanying editorial by Dr. Yogish C Kudva and Dr. Ananda Basu of the department of endocrinology, Mayo Clinic College of Medicine, Rochester, Minn. (Lancet 2011 [doi:10.1016/S0140-6736(11)60097-4). Dr. Kudva and Dr. Basu declared that they have no financial disclosures.
Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.
In addition, degludec achieved those results without additional adverse events.
"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).
Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.
Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.
The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.
They were randomized to one of four groups:
• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).
• Insulin degludec once daily (600 nmol/mL formulation).
• Insulin degludec once daily (900 nmol/mL formulation).
• Insulin glargine once daily (600 nmol/mL formulation).
All four drug regimens were given in combination with metformin.
Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.
After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.
Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.
Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.
Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.
Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.
Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.
In addition, degludec achieved those results without additional adverse events.
"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).
Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.
Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.
The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.
They were randomized to one of four groups:
• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).
• Insulin degludec once daily (600 nmol/mL formulation).
• Insulin degludec once daily (900 nmol/mL formulation).
• Insulin glargine once daily (600 nmol/mL formulation).
All four drug regimens were given in combination with metformin.
Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.
After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.
Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.
Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.
Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.
Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.
FROM THE LANCET
Major Finding: Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between groups taking insulin degludec three times daily, once daily in two different formulations, or once-daily glargine, all combined with metformin.
Data Source: Phase II randomized, open-label trial involving 245 insulin-naive patients with type 2 diabetes inadequately controlled on oral agents.
Disclosures: Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Dr. Kudva and Dr. Basu declared that they have no financial disclosures.