Degludec Group Research Articles

New Medications for the Treatment of Diabetes

New Medications for the Treatment of Diabetes

Insulin glargine versus insulin degludec in patients failing on oral therapy in type 2 diabetes: A retrospective real world comparative data from India

ObjectiveTo compare the changes in various glycemic parameters in insulin-naïve type 2 diabetes mellitus (DM) patients who were initiated on insulin glargine or insulin degludec in a real world setting. MethodsRetrospective data were analyzed in consecutive type 2 DM patients in a real world setting, who failed oral therapy (at least 2 oral anti-diabetic drugs) and were initiated with either insulin glargine or insulin degludec. The parameters assessed were the changes in HbA1c, fasting plasma glucose, body weight, dose of Insulin and the total number of patient reported hypoglycemic episodes up to 6 months after initiation. ResultAt baseline, insulin glargine and insulin degludec groups were similar in terms of gender, age, weight, HbA1c and duration of diabetes. After 6 months follow up the change in HbA1c (−1.09 versus −1.45 P=0.124), change in FPG (−72.81mg/dl [−4mmol/L] versus −75.88mg/dl [−4.2mmol/L] P=0.755), and the change in body weight (+1.65 versus +0.85 P=0.082) were similar in glargine and degludec groups, respectively. Patients in insulin degludec group experienced significantly lesser patient reported hypoglycemic episodes (12 versus 40) and required significantly lesser dose (25.68Units versus 18.61Units per day; P=0.002) compared to insulin glargine. 41% of the patients reached HbA1C target of ≤7% with insulin glargine compared to 69% with insulin degludec within the specified time period. ConclusionResults from this real world analysis suggest that among type 2 DM patients who were initiated on insulin degludec as compared to insulin glargine may be associated with significantly lesser patient reported hypoglycemic episodes and lesser dose of insulin while achieving similar glycemic control. This study is however limited by the retrospective nature of the data collection.

Insulin Degludecimproves Blood Glucose But Does Not Alter Arterial Stiffness in Type 1 Diabetes Patients

Insulin Degludec improves Blood Glucose but Does Not Alter Arterial Stiffness in Type 1 Diabetes Patients Masahiro Ohira, MD, PhD; Atsuhito Saiki, MD, PhD; AyakoNagumo, MD; Haruki Imamura, MD; Hidetoshi Kawana, MD; Kei Endo, MD, PhD; TakeyoshiMurano, MT, PhD; Kohji Shirai, MD, PhD; Ichiro Tatsuno, MD, PhD Abstract Background: Type 1 diabetes mellitus (T1DM) is characterized by insulin deficiency.Insulin degludec is newly developed ultra-long-acting insulin analog. However, the effect of insulin degludec on the artery is unclear. Aim:To study the efficacy of insulin degludec on artery. Methods: 28T1DM patients already onbasalbolus insulin therapy were enrolled.Patients were divided into a group that switched from insulin glargine to insulin degludec (degludec group, n=14) and a group that continued to inject insulin glargine (glargine group, n=14).We observed the change in cardio-ankle vascular index (CAVI) that reflects arterial stiffness. Results: After 6 months,degludecsignificantly improved fasting blood glucose (FBG; -95.57 ± 93.06 mg/dl, P < 0.005) and hemoglobin A1c (HbA1c: -0.73 ± 0.53 %, P < 0.0005).The decreasesinFBG and HbA1c in degludec groupwere significantly differentfrom the changesin glarginegroup (FBG: -95.57 ± 93.06 mg/dl vs+23.21 ± 70.44 mg/dl, P < 0.01; HbA1c: -0.73 ± 0.53 % vs -0.03 ± 0.75 %, P < 0.01).The changeinCAVIwas not significantly different between two groups. Conclusion:These results suggest that switching from insulin glargine to insulin degludec improves blood glucose, but does not ameliorate arterial stiffness. Full Text: PDF DOI: 10.15640/ijmp.v3n2a2

The beneficial effect of insulin degludec on nocturnal hypoglycaemia and insulin dose in type 1 diabetic patients: a systematic review and meta-analysis of randomised trials.

Insulin degludec is a new-generation ultra-long-acting basal insulin which offers a significantly more predictable glucose-lowering effect than other long-acting insulin analogues. The aim of this study was to compare the effect of treatment with insulin degludec and long-acting insulin analogues glargine and detemir in type 1 diabetic (T1D) patients by means of a systematic review and meta-analysis. The following electronic databases were searched up to January 2014: MEDLINE, EMBASE and The Cochrane Library. Additional references were obtained from the reviewed articles. There were included randomised controlled trials of at least 12-week duration with basal-bolus regimen therapies in T1D patients. Current analysis included four studies involving 1,846 T1D patients. The combined data from all trials showed a statistically significant reduction in the basal insulin dose (MD -0.042, 95 % CI -0.067 to -0.018, p = 0.001) and the total daily insulin dose (MD -0.072, 95 % CI 0.016 to -0.027, p = 0.002) in the degludec group compared to other long-acting analogues. There was also a significant reduction of nocturnal hypoglycaemia in the degludec group compared to the controls (rate ratio 0.697, 95 % CI 0.617-0.786, p = 0.000). There were no differences between the groups in terms of glycated haemoglobin values, fasting plasma glucose (FPG) and adverse events. Basal-bolus treatment with insulin degludec was superior to long-acting insulin analogues detemir and glargine in reducing the rate of nocturnal hypoglycaemia. In comparison with other long-acting analogues, treatment with insulin degludec was safe and patients obtained similar metabolic control expressed by HbA1c and FPG levels with the added benefit of a reduced basal and total insulin dose.

Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes

A fixed-ratio combination of the basal insulin analogue insulin degludec and the glucagon-like peptide-1 (GLP-1) analogue liraglutide has been developed as a once-daily injection for the treatment of type 2 diabetes. We aimed to compare combined insulin degludec-liraglutide (IDegLira) with its components given alone in insulin-naive patients. In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day). IDegLira and insulin degludec were titrated to achieve a self-measured prebreakfast plasma glucose concentration of 4-5 mmol/L. The primary endpoint was change in HbA1c after 26 weeks of treatment, and the main objective was to assess the non-inferiority of IDegLira to insulin degludec (with an upper 95% CI margin of 0·3%), and the superiority of IDegLira to liraglutide (with a lower 95% CI margin of 0%). This study is registered with ClinicalTrials.gov, number NCT01336023. 1663 adults (mean age 55 years [SD 10], HbA1c 8·3% [0·9], and BMI 31·2 kg/m(2) [4·8]) were randomly assigned, 834 to IDegLira, 414 to insulin degludec, and 415 to liraglutide. After 26 weeks, mean HbA1c had decreased by 1·9% (SD 1·1) to 6·4% (1·0) with IDegLira, by 1·4% (1·0) to 6·9% (1·1) with insulin degludec, and by 1·3% (1·1) to 7·0% (1·2) with liraglutide. IDegLira was non-inferior to insulin degludec (estimated treatment difference -0·47%, 95% CI -0·58 to -0·36, p<0·0001) and superior to liraglutide (-0·64%, -0·75 to -0·53, p<0·0001). IDegLira was generally well tolerated; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8·8 vs 19·7%), although the insulin degludec group had the fewest participants with gastrointestinal adverse events (nausea 3·6%). We noted no clinically relevant differences between treatments with respect to standard safety assessments, and the safety profile of IDegLira reflected those of its component parts. The number of confirmed hypoglycaemic events per patient year was 1·8 for IDegLira, 0·2 for liraglutide, and 2·6 for insulin degludec. Serious adverse events occurred in 19 (2%) of 825 patients in the IDegLira group, eight (2%) of 412 in the insulin degludec group, and 14 (3%) of 412 in the liraglutide group. IDegLira combines the clinical advantages of basal insulin and GLP-1 receptor agonist treatment, resulting in improved glycaemic control compared with its components given alone. Novo Nordisk.

In search of the ideal basal insulin: Does the new-generation ultra-long-acting insulin, degludec, provide the answer?

In search of the ideal basal insulin: Does the new-generation ultra-long-acting insulin, degludec, provide the answer?

Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial

Basal insulin therapy does not stop loss of β-cell function, which is the hallmark of type 2 diabetes mellitus, and thus diabetes control inevitably deteriorates. Insulin degludec is a new, ultra-longacting basal insulin. We aimed to assess efficacy and safety of insulin degludec compared with insulin glargine in patients with type 2 diabetes mellitus. In this 52 week, phase 3, open-label, treat-to-target, non-inferiority trial, undertaken at 123 sites in 12 countries, we enrolled adults (aged ≥18 years) with type 2 diabetes mellitus and a glycated haemoglobin (HbA(1c)) of 7·0-10·0% after 3 months or more of any insulin regimen (with or without oral antidiabetic drugs). We randomly allocated eligible participants in a 3:1 ratio to receive once-daily subcutaneous insulin degludec or glargine, stratified by previous insulin regimen, via a central interactive response system. Basal insulin was titrated to a target plasma glucose concentration of 3·9-<5·0 mmol/L self-measured before breakfast. The primary outcome was non-inferiority of degludec to glargine measured by change in HbA(1c) from baseline to week 52 (non-inferiority limit of 0·4%) by ANOVA in the full analysis set. We assessed rates of hypoglycaemia in all treated patients. This study is registered with ClinicalTrials.gov, number NCT00972283. 744 (99%) of 755 participants randomly allocated degludec and 248 (99%) of 251 allocated glargine were included in the full analysis set (mean age 58·9 years [SD 9·3], diabetes duration 13·5 years [7·3], HbA(1c) 8·3% [0·8], and fasting plasma glucose 9·2 mmol/L [3·1]); 618 (82%) and 211 (84%) participants completed the trial. After 1 year, HbA(1c) decreased by 1·1% in the degludec group and 1·2% in the glargine group (estimated treatment difference [degludec-glargine] 0·08%, 95% CI -0·05 to 0·21), confirming non-inferiority. Rates of overall confirmed hypoglycaemia (plasma glucose <3·1 mmol/L or severe episodes requiring assistance) were lower with degludec than glargine (11·1 vs 13·6 episodes per patient-year of exposure; estimated rate ratio 0·82, 95% CI 0·69 to 0·99; p=0·0359), as were rates of nocturnal confirmed hypoglycaemia (1·4 vs 1·8 episodes per patient-year of exposure; 0·75, 0·58 to 0·99; p=0·0399). Rates of severe hypoglycaemia seemed similar (0·06 vs 0·05 episodes per patient-year of exposure for degludec and glargine) but were too low for assessment of differences. Rates of other adverse events did not differ between groups. A policy of suboptimum diabetes control to reduce the risk of hypoglycaemia and its consequences in advanced type 2 diabetes mellitus might be unwarranted with newer basal insulins such as degludec, which are associated with lower risks of hypoglycaemia than insulin glargine. Novo Nordisk.