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Safety, efficacy, and early clinical experience of insulin degludec in Japanese people with diabetes mellitus: A first-year report from Japan.

ABSTRACT: In Japan, insulin therapy is recommended for the treatment of type 2 diabetes mellitus either directly after diet, exercise and lifestyle improvements, or if the target for glycemic control is not achieved with other hypoglycemic agents. Insulin degludec is an ultra-long-acting insulin that was launched in Japan in 2013, having shown good efficacy and safety in its clinical development program. It has now been used in clinical practice for more than 1 year. During this time, clinicians and researchers have identified possible factors that could influence the decision as to which patients might be appropriate for insulin degludec treatment. In the present review, we describe how to initiate and manage insulin degludec therapy in routine clinical practice. We also discuss several important topics related to the use of insulin degludec, including patient selection, dosing, handling of bolus insulin, hypoglycemia and other potential safety considerations.

SUBMITTER: Kaku K

PROVIDER: S-EPMC4627535 | biostudies-other | 2015 Nov

REPOSITORIES: biostudies-other

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Safety, efficacy, and early clinical experience of insulin degludec in Japanese people with diabetes mellitus: A first-year report from Japan.

Kaku Kohei K Eid Mohamed A MA

Journal of diabetes investigation 20150420 6

In Japan, insulin therapy is recommended for the treatment of type 2 diabetes mellitus either directly after diet, exercise and lifestyle improvements, or if the target for glycemic control is not achieved with other hypoglycemic agents. Insulin degludec is an ultra-long-acting insulin that was launched in Japan in 2013, having shown good efficacy and safety in its clinical development program. It has now been used in clinical practice for more than 1 year. During this time, clinicians and resea ...[more]

PMID: 26543532

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Project description:BACKGROUND:Degludec is an ultralong-acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes. Previous open-label studies have shown lower day-to-day variability in the glucose-lowering effect and lower rates of hypoglycemia among patients who received degludec than among those who received basal insulin glargine. However, data are lacking on the cardiovascular safety of degludec. METHODS:We randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-to-target, event-driven cardiovascular outcomes trial. The primary composite outcome in the time-to-event analysis was the first occurrence of an adjudicated major cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) with a prespecified noninferiority margin of 1.3. Adjudicated severe hypoglycemia, as defined by the American Diabetes Association, was the prespecified, multiplicity-adjusted secondary outcome. RESULTS:Of the patients who underwent randomization, 6509 (85.2%) had established cardiovascular disease, chronic kidney disease, or both. At baseline, the mean age was 65.0 years, the mean duration of diabetes was 16.4 years, and the mean (±SD) glycated hemoglobin level was 8.4±1.7%; 83.9% of the patients were receiving insulin. The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (hazard ratio, 0.91; 95% confidence interval, 0.78 to 1.06; P<0.001 for noninferiority). At 24 months, the mean glycated hemoglobin level was 7.5±1.2% in each group, whereas the mean fasting plasma glucose level was significantly lower in the degludec group than in the glargine group (128±56 vs. 136±57 mg per deciliter, P<0.001). Prespecified adjudicated severe hypoglycemia occurred in 187 patients (4.9%) in the degludec group and in 252 (6.6%) in the glargine group, for an absolute difference of 1.7 percentage points (rate ratio, 0.60; P<0.001 for superiority; odds ratio, 0.73; P<0.001 for superiority). Rates of adverse events did not differ between the two groups. CONCLUSIONS:Among patients with type 2 diabetes at high risk for cardiovascular events, degludec was noninferior to glargine with respect to the incidence of major cardiovascular events. (Funded by Novo Nordisk and others; DEVOTE ClinicalTrials.gov number, NCT01959529 .).

Project description:IntroductionTwo studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy.Materials and methodsIn the trial involving add-on to sulfonylureas (study 03-1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24-week double-blind period, followed by a 28-week open-label period. In the open-label trial involving add-on to other OADs; that is, biguanides, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, glinides and ?-glucosidase inhibitors (study 03-2), patients received luseogliflozin for 52 weeks.ResultsIn study 03-1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24-week double-blind period compared with the placebo (-0.88%, P < 0.001), and glycated hemoglobin reduction from baseline at week 52 was -0.63%. In study 03-2, luseogliflozin added to other OADs significantly decreased glycated hemoglobin from baseline at week 52 (-0.52 to -0.68%, P < 0.001 for all OADs). Bodyweight reduction was observed in all add-on therapies, even with agents associated with weight gain, such as sulfonylureas and thiazolidinediones. Most adverse events were mild in severity. When added to a sulfonylurea, incidences of hypoglycemia during the double-blind period were 8.7% and 4.2% for luseogliflozin and placebo, respectively, but no major hypoglycemic episodes occurred. The frequency and incidences of adverse events of special interest for sodium glucose cotransporter 2 inhibitors and adverse events associated with combined OADs were acceptable.ConclusionsAdd-on therapies of luseogliflozin to existing OADs improved glycemic control, reduced bodyweight and were well tolerated in Japanese type 2 diabetic patients. These trials were registered with the Japan Pharmaceutical Information Center (add on to sulfonylurea: JapicCTI-111507; add on to other OADs: JapicCTI-111508).

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Safety, efficacy, and early clinical experience of insulin degludec in Japanese people with diabetes mellitus: A first-year report from Japan.

Publications

Safety, efficacy, and early clinical experience of insulin degludec in Japanese people with diabetes mellitus: A first-year report from Japan.

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