Insulin Glargine and Educational Intervention in Patients with Type 2 Diabetes in Clinical Practice: Long-Term Improvement in Glycaemic Control Without Weight Gain

Dear Editors,

In clinical practice it is often difficult to achieve the stringent HbA1c targets set by organizations such as the American Diabetes Association (ADA) for patients with Type 2 diabetes. This is due to a number of factors including insufficient glycaemic control with oral antidiabetic agents (OADs) combined with physician and/or patient reluctance to commence insulin therapy; inadequate insulin titration due to fear of hypoglycaemia; and a lack of patient education regarding correct diabetes management. Self-managed patients in an outpatient setting need to be motivated and compliant in order to optimize treatment success ([Mudaliar and Edelman, 2001]), to which distinct barriers exist ([Brown et al., 2002]). The benefits of educational programmes in improving health outcomes, including metabolic control, have been documented; however, such programmes are under-utilized ([Graziani et al., 1999]). The current retrospective analysis assessed the effect of 30 months' treatment following initiation of once-daily insulin glargine (glargine; LANTUS), a long-acting basal insulin analogue, plus ongoing previous oral or prandial insulin therapy, in conjunction with an educational programme, on glycaemic control, body weight, and incidence of severe hypoglycaemia in patients with Type 2 diabetes undergoing routine diabetes care in a clinical practice in Germany.

In the current investigation, patients were initiated onto glargine therapy for the following reasons: inadequate control on previous OAD or insulin treatment (HbA1c > 7 %/fasting blood glucose [FBG] > 140 mg/dL [> 7.8 mmol/L]); body mass index (BMI) ≥ 25 kg/m²; patients who specifically requested glargine therapy from their physician. Glargine was initiated as follows: insulin-naïve patients on OADs received ≤ 8 IU (normal BMI) or ≤ 12 IU (BMI ≥ 25 kg/m²) glargine and were stabilized on each incremental dose for ≥ 5 days before further increases were made to a target FBG of 80 - 120 mg/dL (4.4 - 6.7 mmol/L). Prior OAD regimens were maintained throughout. These patients contacted the clinical practice daily to report blood glucose measurements until the target FBG was met. Insulin-experienced patients were treated as follows: those on twice-daily NPH insulin plus prandial insulin (intensified conventional therapy [ICT]) were switched to once-daily glargine at a dose of 80 % of their previous NPH insulin dose and titrated until the target FBG (80 - 120 mg/dL) was reached. Prandial insulin was continued. Patients on twice-daily premixed insulin (conventional insulin therapy [CIT]) were switched to once-daily insulin glargine plus prandial insulin. Before glargine initiation, insulin-experienced patients took part in a 12-lesson educational programme on ICT (Table [1]). Previously insulin-naïve patients participated in a shorter version of this programme (5 lessons; Table [1]). Throughout the 30 months, patients met with their physician every 4 - 8 weeks to receive continued treatment and educational support. Metabolic control (HbA1c; HPLC technique, DCCT-calibrated, reference range 4.7 - 6.7 %) and body weight were recorded at 0, 9, 18, and 30 months. All variables were analysed using a paired t-test, from which mean values and standard deviations were derived.

Table 1 Details of the 12-lesson educational programme on intensified conventional therapy undertaken by previously insulin-experienced patients Lesson (90 minutes each) Topic Week 1 What is diabetes? Insulin and injection technique* Hypoglycaemia Food and diet* Week 2 Blood glucose self-monitoring* Identifying carbohydrates in meals Hypoglycaemia*: reasons for hypoglycaemia, treatment of hypoglycaemia, glucagon and its use Week 3 Different types of diabetes Quantifying carbohydrates in a meal Week 4 Adapting insulin doses: reduction (repetition) Week 5 Adapting insulin doses: increments of insulin doses (repetition) Week 6 Sport and physical exercise* Food: sweetners, alcohol, diabetes in restaurants, energy from carbohydrates, fats and proteins Week 7 HbA1c: complications of diabetes Smoking Precaution and prevention of diabetes complications* Week 8 Food and diet: shopping in a supermarket Week 9 Insulin pump Food and diet (repeat) Week 10 Control of glucosurea Travelling Adapting insulin doses: reduction (repeat) Week 11 Correcting blood glucose levels Metabolic control Adapting insulin doses: increments (repeat) Week 12 Social questions (pension, insurance, occupation) * Indicates the shortened version of the programme undertaken by previously insulin-naïve patients

Results from our investigation showed that 46 patients were analysed (41 % female; mean age 61.5 ± 8.6 years). Previous treatment regimens included OADs only (n = 18) of once-daily glimepiride with or without metformin or twice-daily glibenclamide. Other previous treatment regimens included insulin therapy only (n = 28) of either CIT or ICT. CIT consisted of twice-daily premixed insulin (30 % regular human insulin [RHI]/70 % NPH insulin). ICT consisted of twice-daily basal insulin (morning NPH insulin plus bedtime NPH insulin or insulin lente) with RHI or a rapid-acting analogue at mealtimes and for correction of high blood glucose at other times. Following initiation of glargine, there was a significant reduction in HbA1c at 9 and 30 months (Fig. [1]). There was no significant change in body weight (baseline: 86 ± 17.7; 30 months: 86 ± 18.2 kg) and no serious hypoglycaemic episodes were recorded.

Fig. 1 Metabolic control (HbA1c) in patients with Type 2 diabetes following initiation of insulin glargine therapy in combination with an educational programme. OAD = oral antidiabetic agents; * p < 0.002; † p < 0.001; ‡ p < 0.015; ∞ p < 0.005; all from baseline; Data are mean plus standard deviation.

This retrospective analysis reflects data obtained from true clinical practice over 30 months following initiation of glargine in combination with an educational programme in insulin-naïve and insulin-experienced patients with Type 2 diabetes. Although it is not possible to distinguish between the effects of glargine and the educational programme, it is likely that both contributed to the improvement in metabolic control and stabilized body weight observed. All patients chose to remain on glargine after 30 months and those previously on ICT reported a preference for the once-daily dosing regimen of glargine. This study supports the beneficial effects of glargine observed in clinical trials as well as the benefit of educational programmes in everyday clinical practice.

This study was not sponsored; however, data from this study have previously been published as abstracts at two ADA congresses: Diabetes 2002; 51 (Suppl 2): A114 (Abstract 464), Diabetes 2003; 52(Suppl 1): A455 (Abstract 1972), the International Diabetes Federation 2003 congress: Diabetes Metab 2003; 29 (Spec No 2): 4S231 (Abstract 2212) and the European Association for the Study of Diabetes 2004 congress: Diabetologia 2004; 47 (Suppl 1): A271 (Abstract 748).

References

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• 2 Graziani C, Rosenthal M, Diamond J. Diabetes education program use and patient-perceived barriers to attendance.  Fam Med. 1999;  31 358-363
• 3 Mudaliar S, Edelman S V. Insulin therapy in type 2 diabetes.  Endocrinol Metab Clin North Am. 2001;  30 935-982