Rates Of Confirmed Hypoglycemia Research Articles

Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Renal Transplantation with Pre-existing Type 2 Diabetes Mellitus; A 1-year, Randomized, Treat-to-Target Pilot Trial.

Introduction. This study hypothesized that the insulin Degludec may have benefit if used in management of diabetes mellitus after renal transplantation to achieve better control at the critical time of adjustment of immunosuppressive regimens during the first year post transplant. Methods. Fifty patients with Type 2 diabetes Mellitus after renal transplantation with stable serum creatinine with glycosylated hemoglobin (HbA1C) 7 to 11% were included in the study to receive either Insulin Degludec or Insulin Glargine. Fasting blood glucose, 2 hour post-prandial levels and (HbA1c), were measured at 12, 16, 26, 40, and 52 weeks after renal transplantation also hypoglycemic episodes were documented all through the study. Results. Despite both groups are matched as regards demographic and metabolic data, FPG, and 2h PPG were lower in insulin Degludec group all through the study. HbA1c most pronounced decline, occurred at 52th week of treatment in both groups. The most important clinically relevant finding in our study was that; the overall confirmed hypoglycemia rates and the rate of nocturnal confirmed hypoglycemia was significantly lower with Degludec treated group (P < .001). Conclusion. Insulin Degludec provides optimum glycemic control in in the first year post-renal transplant patients with significantly lower rate of hypoglycemia. DOI: 10.52547/ijkd.6131

Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial.

Insulin degludec/insulin aspart (IDegAsp) is a fixed soluble co-formulation of basal and bolus insulin. To evaluate efficacy and safety of IDegAsp in pediatric patients with type 1 diabetes (T1D). Children and adolescents (aged 1 to <18 years) with T1D. A 16-week, phase 3b, treat-to-target, parallel-group, open-label, non-inferiority trial was conducted at 63 sites in 14 countries from October 2013 to November 2014. Patients were randomized 1:1 (age stratified: 1-<6 years; 6-<12 years; 12-<18 years) to IDegAsp once daily (OD) plus insulin aspart (IAsp) for remaining meals (IDegAsp + IAsp), or IDet OD or twice daily plus mealtime IAsp (IDet + IAsp). The primary end-point was HbA1c change from baseline at week 16. A total of 362 participants were randomized to IDegAsp + IAsp (n = 182) or IDet + IAsp (n = 180). HbA1c decreased from baseline to week 16 by 0.3% in both groups (estimated treatment difference: -0.04%-points [-0.23; 0.15]95%CI (-0.45 mmol/mol [-2.51; 1.60]95%CI ), confirming non-inferiority. There were no significant differences between treatment groups in fasting or self-measured plasma glucose. Confirmed hypoglycemia rates did not significantly differ between groups. There was a significant reduction in basal and total insulin dose with IDegAsp + IAsp vs IDet + IAsp (post hoc analysis). Mean number of injections/day was 3.6 and 4.9 with IDegAsp + IAsp and IDet + IAsp, respectively (post hoc analysis). A non-significant higher rate of severe hypoglycemia was observed with IDegAsp + IAsp vs IDet + IAsp. The most frequent adverse events in both groups were hypoglycemia, headache, and nasopharyngitis. IDegAsp + IAsp was non-inferior to IDet + IAsp regarding HbA1c, had similar hypoglycemia rates and required fewer injections.

Fasting Versus Postprandial Hyperglycemia as a Treatment Target to Lower Elevated Hemoglobin A1C

Postprandial hyperglycemia (PPHG) may need addressing when glycemic control cannot be maintained in patients with type 2 diabetes mellitus. We investigated whether glycated hemoglobin A1c (A1c) levels ≥7.0% can indicate postprandial defects warranting prandial therapy after optimized basal insulin therapy. From 6 clinical trials of insulin glargine treatment, data were pooled from 496 patients with A1c ≥7.0% after 24 weeks. Patient characteristics and clinical outcomes were summarized according to fasting plasma glucose (FPG) target achievement (<130 mg/dL), postprandial blood glucose (PPBG) levels, and PPBG increments (ΔPPBG). Basal and postprandial contributions to hyperglycemia were determined. After 24 weeks of insulin glargine titration, A1c change from baseline was greater in patients with FPG <130 mg/dL versus ≥130 mg/dL (-1.35% versus -1.11%, respectively; P = .0275), but with increased confirmed hypoglycemia rates (blood glucose <70 mg/dL; 4.06 events/patient-year versus 3.31 events/patient-year; P = .0170). However, increased severe hypoglycemia rates were observed in patients with FPG ≥130 mg/dL. At week 24, postprandial contributions to hyperglycemia increased (>60% regardless of PPBG). Patients with high FPG had lower, but substantial, relative postprandial contributions versus patients achieving FPG target. A similar pattern was observed according to whether patients had a ΔPPBG ≥50 mg/dL after any meal. After optimized basal insulin therapy, elevated A1c is the most effective indicator of residual PPHG, regardless of existent FPG or PPBG. When confronted with an uncontrolled A1c after reasonable titration of basal insulin, clinicians should be aware of probable postprandial contributions to hyperglycemia and consider prandial therapy.

Insulin degludec in Japanese patients with type 1 diabetes mellitus: A randomized controlled trial

Insulin degludec is an ultra-long-acting insulin with a flat time-action profile and duration of action >42h. Data from several studies have shown insulin degludec to have a favorable therapeutic profile in type 1 and type 2 diabetes. This was a 6-week, parallel-group, randomized controlled trial carried out in 65 Japanese patients with type 1 diabetes, previously treated with mealtime insulin aspart and either insulin glargine or neutral protamine Hagedorn insulin. Patients were randomized to receive either insulin degludec or insulin detemir, each once daily and at the same unit dose as pretrial basal insulin. During the trial, basal insulin was titrated according to a prespecified algorithm in order to achieve a fasting plasma glucose target of 80-109mg/dL. No severe hypoglycemia occurred; there was no significant difference in confirmed hypoglycemia rates with insulin degludec and insulin detemir (rate ratio degludec/detemir 0.78; 95% confidence interval 0.45-1.34). The rate of nocturnal confirmed hypoglycemia was 69% lower with insulin degludec than with insulin detemir (rate ratio 0.31; 95% confidence interval 0.13-0.78). Final fasting plasma glucose levels were similar (insulin degludec 147mg/dL, insulin detemir 136mg/dL), despite differing baseline fasting plasma glucose levels. In conclusion, no concerns relating to hypoglycemia or general safety were observed when initiating insulin degludec in Japanese patients with type 1 diabetes at the same unit dose as previous basal insulin. This trial was registered with ClinicalTrials.gov (no. NCT00841087).

Insulin Degludec is Superior to Sitagliptin in Improving Glycemic Control in Insulin-naïve Patients with Type 2 Diabetes

The efficacy and safety of ultra-long-acting insulin degludec (IDeg) was compared with sitagliptin (Sita), a DPP-4-inhibitor, in a 26-week, open-label trial. 458 insulin-naïve adults with type 2 diabetes (mean age: 56 yrs, diabetes duration: 7.7 yrs, HbA1c 8.9%) were randomized (1:1) to once-daily IDeg or Sita (100 mg orally) in addition to 1-2 OADs. The completion rate was 76% in both treatment arms. IDeg was superior to Sita in improving HbA1c, (estimated treatment difference [ETD] IDeg-Sita: -0.43% points, [95%CI: -0.61, -0.24; p<0.0001] with observed mean reductions of 1.56% vs. 1.22%-points, respectively). HbA1c <7% was achieved by 41% (IDeg) vs. 28% (Sita) of patients, p=0.034. IDeg was superior to Sita in reducing FPG (ETD IDeg-Sita: -2.17 mmol/L [-2.59, -1.74; p<0.0001] with observed mean reductions of 3.22 vs. 1.39 mmol/L, respectively. There was no significant difference in the rate of nocturnal confirmed hypoglycemia (PG <3.1 mmol/L, occurring 00:01 to 05:59, inclusive) between IDeg and Sita (0.52 vs. 0.30 episodes/patient-yr, estimated rate ratio (ERR): IDeg:Sita: 1.93 [0.90, 4.10; p=0.09]). Overall confirmed hypoglycemia rates were higher with IDeg than with Sita (3.1 vs. 1.3 episodes/patient-yr, ERR IDeg:Sita: 3.81 [2.40, 6.05; p<0.0001]); one severe episode was reported with IDeg. Weight gain was greater with IDeg: ETD IDeg-Sita: 2.75 kg [1.97, 3.54; p<0.0001]. Adverse events rates were low for both groups. IDeg was superior to Sita in improving glycemic control; overall hypoglycemia was higher with IDeg, but there was no difference in severe or nocturnal hypoglycemia. IDeg is an effective and well-tolerated alternative to additional OADs.