New post-hoc analysis shows patients with type 2 diabetes undergoing intensification of insulin therapy experienced less nighttime hypoglycemia while being treated with Januvia (Sitagliptin) compared
WHITEHOUSE STATION, N.J., June 14, 2014 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a post-hoc analysis showing that patients with type 2 diabetes having treatment intensified with insulin glargine therapy while also being treated with JANUVIA® (sitagliptin) 100 mg once-daily had a lower incidence of nighttime (nocturnal) hypoglycemia compared to patients also receiving placebo. Results were presented at the American Diabetes Association 74th Scientific Sessions.
"Type 2 diabetes is a progressive disease, so that over time many patients need to add insulin to their treatment regimens to maintain blood sugar control," said Peter Stein, M.D., vice president, Clinical Research for diabetes and endocrinology, Merck Research Laboratories. "Insulin therapy can lead to episodes of hypoglycemia that can occur either during the day or overnight while the patient is asleep. Hypoglycemia is troubling to both the patient and to the physician, so treatment approaches that can potentially lower the occurrence of hypoglycemia—overall or overnight—may be important."
JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA. JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.
Results of the original study: The original clinical trial, "A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin," was conducted over 24 weeks in 660 insulin-treated patients, randomized to the addition of either JANUVIA (sitagliptin) 100 mg once-daily (n=329) or placebo (n=329) to their insulin regimen. Starting two weeks after randomization, patients were to increase their dose of insulin every three days to reach a targeted fasting blood sugar level of 72-100 mg/dL. After 24 weeks, patients randomized to JANUVIA received less additional insulin compared to patients randomized to placebo.
The study also found that patients in the group randomized to JANUVIA had better blood sugar control after 24 weeks with a significantly lower incidence of hypoglycemia. The group randomized to JANUVIA had an A1C [1] reduction (-1.31% LS mean A1C reduction from a baseline of 8.66%) that was significantly greater than the reduction in the group randomized to placebo (-0.87% LS mean reduction from a baseline of 8.81%; difference between groups p END
"Type 2 diabetes is a progressive disease, so that over time many patients need to add insulin to their treatment regimens to maintain blood sugar control," said Peter Stein, M.D., vice president, Clinical Research for diabetes and endocrinology, Merck Research Laboratories. "Insulin therapy can lead to episodes of hypoglycemia that can occur either during the day or overnight while the patient is asleep. Hypoglycemia is troubling to both the patient and to the physician, so treatment approaches that can potentially lower the occurrence of hypoglycemia—overall or overnight—may be important."
JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA. JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.
Results of the original study: The original clinical trial, "A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin," was conducted over 24 weeks in 660 insulin-treated patients, randomized to the addition of either JANUVIA (sitagliptin) 100 mg once-daily (n=329) or placebo (n=329) to their insulin regimen. Starting two weeks after randomization, patients were to increase their dose of insulin every three days to reach a targeted fasting blood sugar level of 72-100 mg/dL. After 24 weeks, patients randomized to JANUVIA received less additional insulin compared to patients randomized to placebo.
The study also found that patients in the group randomized to JANUVIA had better blood sugar control after 24 weeks with a significantly lower incidence of hypoglycemia. The group randomized to JANUVIA had an A1C [1] reduction (-1.31% LS mean A1C reduction from a baseline of 8.66%) that was significantly greater than the reduction in the group randomized to placebo (-0.87% LS mean reduction from a baseline of 8.81%; difference between groups p END