Insulin Initiation in Patients not Adequately Controlled on Oral Agents
Insulin Initiation in Patients not Adequately Controlled on Oral Agents
Published: October 2008
It is well established that tight glycaemic control in type 2 diabetes (T2DM) reduces the risk of microvascular complications. The majority of patients will, at some point, need to start insulin therapy in order to achieve the American Diabetes Association (ADA) goal of a glycated haemoglobin (HbA1c) below 7%. This is largely because of the progressive loss of betacell function associated with the course of T2DM. Adding insulin to oral agent therapy can be an effective means of reaching the target level for HbA1c. This approach has proved to be feasible in clinical trials that rely on dose-titration protocols for regular adjustment of the insulin dose. Furthermore, reliable patients should be able to follow such protocols and make dose changes based on their home glucose-monitoring values.
The timely addition of insulin to an oral agent regimen along with close attention to its optimal dosing will lead to better glucose control, which will translate into better health for these patients.T2DM is associated with enormous morbidity and mortality. In the US, it contributes to more cases of adult-onset loss of vision, renal failure and amputation than any other disease.1 Diabetes is also a major risk factor for cardiovascular disease. Patients with T2DM have a two- to five-fold increased risk for cardiovascular disease compared with patients without diabetes.1 About 80% will die from cardiovascular disease.2 Clinical trials have shown that maintaining tight glycaemic control can prevent the onset and slow the progression of microvascular complications in T2DM.3,4 Epidemiological data have suggested that cardiovascular disease may be prevented as well.5 Data from these studies have helped the ADA establish its 2007 clinical practice recommendations for glycaemic control. For patients in general, the goal is <7%, while the goal for the individual patient is an HbA1c as close to normal (<6%) as possible without significant hypoglycaemia.6
The Challenge of Maintaining Glycaemic Control
Maintaining HbA1C <7% is a challenge in clinical practice. Despite publication of an evidence-based HbA1C target, the majority of adults with T2DM in the US probably do not have an HbA1C value <7%. In fact, analysis of data from the National Health and Nutrition Examination Survey (NHANES) III revealed that mean HbA1c values of patients with T2DM actually deteriorated from the study years of 1988–1994 and 1999–2000, and that a smaller percentage had HbA1C values below 7%.7
Higher rates of control have been reported in patients with T2DM who are being managed by endocrinologists.8 A more common use of insulin in this setting may be a reason for this observation.Delay in starting insulin is an important reason why patients with T2DM do not reach the HbA1c goal. Insulin is often started after oral agents have failed to control hyperglycaemia for an extended period of time. The lack of timely progression of therapy to maintain good control in patients with T2DM is illustrated in a study that examined the pattern of use of oral agents in the treatment of T2DM.9 From the time of diagnosis to the start of insulin therapy, the average patient had spent five years with HbA1c above 8% and 10 years above 7%.Diminished insulin secretion due to a progressive loss of beta-cell function limits the amount of time during which oral agents by themselves are able to maintain HbA1c below 7%. Most people with T2DM will require insulin therapy in order to maintain this degree of control.10 Any delay in starting insulin, as the disease progresses, puts patients at risk of developing diabetic complications.
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