Basal Insulin Therapy in Type 2 Diabetes

Abstract

OBJECTIVE -To determine the safety and efficacy of the long-acting analog insulin glargine compared with NPH insulin in patients with type 2 diabetes who were previously treated with insulin alone. RESEARCH DESIGN AND METHODS-A total of 518 subjects with type 2 diabetes who were receiving NPH insulin with or without regular insulin for postprandial control were randomized to receive insulin glargine (HOE 901) once daily (n ϭ 259) or NPH insulin once or twice daily (n ϭ 259) for 28 weeks in an open-label, multicenter trial. Doses were adjusted to obtain target fasting glucose Ͻ6.7 mmol/l. At study end point, the median total daily insulin dose in both treatment groups was 0.75 IU/kg. RESULTS -The treatment groups showed similar improvements in HbA 1c from baseline to end point on intent-to-treat analysis. The mean change (means Ϯ SD) in HbA 1c from baseline to end point was similar in the insulin glargine group (Ϫ0.41 Ϯ 0.1%) and the NPH group (Ϫ0.59 Ϯ 0.1%) after patients began with an average baseline HbA 1c of ϳ8.5%. The treatments were associated with similar reductions in fasting glucose levels. Overall, mild symptomatic hypoglycemia was similar in insulin glargine subjects (61.4%) and NPH insulin subjects (66.8%). However, nocturnal hypoglycemia in the insulin glargine group was reduced by 25% during the treatment period after the dose-titration phase (26.5 vs. 35.5%, P ϭ 0.0136). Subjects in the insulin glargine group experienced less weight gain than those in the NPH group (0.4 vs. 1.4 kg, P Ͻ 0.0007).CONCLUSIONS -In patients with type 2 diabetes, once-daily bedtime insulin glargine is as effective as once-or twice-daily NPH in improving and maintaining glycemic control. In addition, insulin glargine demonstrates a lower risk of nocturnal hypoglycemia and less weight gain compared with NPH insulin. Diabetes Care 24:631-636, 2001I nsulin treatment can improve and maintain glycemic control, preventing long-term complications in type 2 diabetes (1-3). Over time, most patients with type 2 diabetes experience progressive ␤-cell dysfunction and will require insulin therapy, either alone or in combination with oral agents, for satisfactory glycemic control (4). Attempts to mimic physiologic patterns of basal insulin secretion have been difficult because most currently available insulins have disadvantages, including variable absorption, pronounced peaks after injection, and abbreviated durations of action (5-8).The novel recombinant insulin analog insulin glargine (HOE 901; 21b-L-Arg-human insulin) is a modification of human insulin in which two arginines are added to the B-chain and glycine is substituted for asparagine at the A21 position of the insulin molecule. These changes cause a shift of the isoelectric point to a neutral pH (9 -11), precipitation at physiologic tissue pH, and increased hexamer stability, resulting in delayed absorption and a flat profile after injection, compared with the shorter duration of action and early peak of NPH insulin (9 -12). Short-term clinical trials in patients with type 1...

Does diabetes therapy influence the risk of cancer?

“…Curiously, this fact is not mentioned in the original report [44], which concludes with the statement that insulin glargine has a safety profile that, apart from reduced nocturnal hypoglycaemia, is 'otherwise similar to NPH insulin'. Equally curious, a later review also cites the same paper as documenting a three step or greater retinopathy progression in 7.5% of those on insulin glargine vs 2.7% of those on NPH (p<0.05) [45].…”

“…A further safety concern requiring human studies arose when one of the early clinical trials [44] was reported to have observed a threefold increase in retinopathy progression with insulin glargine compared with human insulin [41]. Curiously, this fact is not mentioned in the original report [44], which concludes with the statement that insulin glargine has a safety profile that, apart from reduced nocturnal hypoglycaemia, is 'otherwise similar to NPH insulin'.…”

Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence

“…98,99 This weight-sparing phenomenon appears to be unique for insulin detemir. While some studies have shown that patients treated with insulin glargine initially gain less weight relative to those treated with NPH, 100,101 no difference between insulin glargine and NPH was noted in patients treated for 1 year. 97 Moreover, in a recently reported study, patients with type 2 diabetes were switched from NPH insulin or insulin glargine to insulin detemir for their basal insulin supply in combination with oral anti-diabetic drugs.…”

Effect of Initiation of Basal Insulin Glargine on Glycemic Control in Patients with Diabetes: Real Life Experience from Hong Kong

“…Adherence to insulin therapy was reported to be inadequate [30] [31] and numerous factors related to patient and physician perceptions were thought to be responsible for treatment compliance [28]. In our study, a discontinuation rate was of only four percent at the end of 12 months following the initiation of insulin glargine.…”