Clinical study of treatment switching from premixed insulin to basal insulin combined with oral hypoglycemic drugs in patients with type 2 diabetes

Abstract

AimPremixed insulin regimens are commonly used for the treatment of patients with type-2 diabetes mellitus (T2DM). However, limited data are available regarding next-step therapy options in cases where premixed insulin fails to provide adequate glycemic control. This 20-week observational study of everyday clinical practice evaluated the efficacy, safety and treatment satisfaction of insulin glargine plus oral anti-diabetic drugs (OADs) in T2DM patients previously treated with premixed insulin.MethodsIn this open-label, single-arm, 20-week study, 70 subjects with T2DM inadequately controlled with premixed insulin were switched to insulin glargine plus OADs. Changes in glycaemic control, incidence of hypoglycaemia, treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (DTSQ), serum superoxide dismutase (SOD), and serum 8-iso-prostaglandin (8-iso-PG) were evaluated at the start and the end of the study.ResultsOver the 20 week treatment period, mean (±SD) HbA1c levels decreased from 8.28 ± 1.24% to 6.83 ± 1.09%, mean (±SD) FBG levels decreased from 7.64 ± 1.36 mmol/L to 5.57 ± 1.21 mmol/L, and 2 h PBG levels decreased from 12.07 ± 1.17 mmol/L to 8.94 ± 1.56 mmol/L, all P < 0.001. A total of 3 symptomatic hypoglycemic episodes were reported. No significant reductions in body weight were observed. The mean daily dose of insulin decreased by 14 U between week 0 (30.20 ± 9.93 U) and week 20 (16.38 ± 5.15 U). The total treatment satisfaction score showed a significant increase from study baseline to end point. Significant increases in SOD(90.00 ± 16.62 to 108.81 ± 27.02 u/ml, P < 0.01) and reductions in 8-iso-PG(2.15 ± 0.61 to 1.64 ± 0.42 pg/ml, P < 0.05) were observed between the start and end of the observation period. There were significant differences in baseline HbA1c, duration of diabetes, and baseline postprandial C-peptide between the A1c ≤ 6.5% group and the A1c > 7.0% group [HbA1c: 7.25% ± 1.02% vs. 9.32% ± 1.23%; duration: 7.84 ± 1.02 vs. 13.96 ± 1.35 years; postprandial C-peptide: 4.83 ± 2.11 vs 2.54 ± 0.87 nmol/L, all P < 0.05].ConclusionsThe observational study shows that, in T2DM patients inadequately controlled with premixed insulin, switching therapy to glargine plus OADs is associated with significant improvements in glycaemic control and treatment satisfaction, and is with low incidence of hypoglycemia. Baseline postprandial C-peptide, HbA1c, and duration of diabetes are the key factors closely related to efficacy of this treatment regimen.

Glycemic control and safety in Chinese patients with type 2 diabetes mellitus who switched from premixed insulin to insulin glargine plus oral antidiabetics: a large, prospective, observational study

“…These findings are consistent with results from a previous observational study carried out in Germany and support similar findings from two smaller studies conducted in China . In the current study, HbA1c levels were decreased by –0.8% from baseline, and FPG levels and 2‐hour PPG levels were decreased from baseline by –1.4 mmol/L and –2.1 mmol/L, respectively.…”

“…In terms of safety, the current study shows a low incidence of hypoglycemic events associated with insulin glargine, similar to that observed in a previous German observational study, and in support of similar findings from two smaller Chinese studies . These results suggest that insulin glargine plus OADs is a relatively safe therapeutic option for patients with T2DM who fail to achieve glycemic control with premixed insulin.…”

“…In the current study, HbA1c levels were decreased by –0.8% from baseline, and FPG levels and 2‐hour PPG levels were decreased from baseline by –1.4 mmol/L and –2.1 mmol/L, respectively. HbA1c levels in the previous studies decreased in the range of –0.51% to –1.45%, FPG decreased between 2.07 and 3.0 mmol/L, and 2‐hour PPG decreased between 2.41 and 3.13 mmol/L . Interestingly, the greatest improvements in glycemic control across these three parameters tended to occur in patients involved in the studies of longer duration, or where the patients had received premixed insulin alone with no concomitant OADs before the switch to insulin glargine plus OADs.…”

“…Data from a large observational study conducted in Germany suggest that switching to insulin glargine (a long‐acting basal insulin analog) plus OADs results in significant improvements in glycemic control in patients who fail to achieve this using premixed insulin . Similar improvements in glycemic control after switching to insulin glargine have also been observed in two more recent studies in Chinese patients with T2DM . However, the applicability of the results of these two observational studies to the general population of patients with T2DM in China may be limited because of relatively small patient numbers and, in the case of one of the studies, the inclusion of patients from a single center only.…”

Screening the Effect of Metformin on Serum Vitamin B12 and Blood Homocysteine Levels in Patients with Type 2 Diabetes Mellitus

“…When lifestyle modification fails to achieve adequate glycaemic control, oral hypoglycemic agents are introduced as a treatment approach. [1,2] If metformin is not contraindicated and can be tolerated, it should be considered as the firstline therapy in newly diagnosed T2DM patients with HbA1cless than 9%. [3] This is attributed to the advantages of weight loss, good initial efficacy in decreasing fasting plasma glucose in overweight and obese individuals with T2DM, and low cost [4].…”