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IIMPROVED METABOLIC CONTROL IN PATIENTS WITH TYPE 1 AND TYPE 2 DIABETES FOLLOWING THE INITIATION/SWITCHING TO INSULIN GLARGINE (LANTUS®) IN CLINICAL PRACTICE
STEPHAN A SCHREIBER AND ANIKA RUßMANN
ABSTRACT
Effective treatment of diabetes requires the optimization of insulin therapy and the education of patients on
diabetes self-management. In this open-label, 9-month, single-center study the effect of insulin glargine
(LANTUS®) on glycemic control and weight gain in patients with Type 1 and Type 2 diabetes was investigated.
Eighty-nine patients with Type 1 diabetes (mean age 38.7 ± 12.7 years) and 60 patients with Type 2 diabetes
(mean age 60.2 ± 8.1 years) were administered insulin glargine, a long-acting insulin analog. Patients were
educated on either basal–bolus therapy, if switched from a previous insulin regimen or on initiation of insulin
therapy, if not previously treated with insulin. Patients with Type 1 diabetes continued their treatment regimen
using insulin glargine as their basal insulin instead of NPH insulin. Patients with Type 2 diabetes started
insulin therapy with insulin glargine in addition to their oral treatment or were switched to the basal insulin
glargine within their combination regimen. A significant reduction in HbA1c was achieved with insulin glargine
and was maintained during the study period. Although there was variability in the weight change over the
study duration, weight was reduced overall. No unexpected adverse events or episodes of severe
hypoglycemia were detected. Treatment with insulin glargine over a 9-month period significantly improved
metabolic control, and induced weight loss in patients with Type 1 and Type 2 diabetes.
INTRODUCTION
● Optimizing existing insulin therapy is central to improving metabolic control in patients with Type 1
● Educating patients about the importance of diabetes self-management is an essential component of ● NPH insulin has provided the mainstay basal insulin in patients with Type 1 and Type 2 diabetes for ● However, the duration of action of NPH insulin is too short for it to provide 24-hour glycemic ● Insulin glargine (LANTUS®) is a new, long-acting human insulin analog that provides an effective basal insulin supply when administered once daily, shows no pronounced peaks, mimics physiologic basalinsulin over a 24-hour period and provides equivalent glycemic control to that of NPH insulin3–5 ● A single daily dose of insulin glargine is associated with less hypoglycemia than NPH insulin4 STUDY OBJECTIVES
● To determine the effect of insulin glargine on glycemic control and body weight in patients with Type
1 or Type 2 diabetes who:– were previously taking NPH insulin as their basal insulin therapy, or– were not previously receiving insulin therapy (some of the patients with Type 2 diabetes) ● To improve patient education regarding self-management of insulin therapy in order to optimize glycemic control and minimize weight gain STUDY DESIGN AND METHODS
Patients
● Patients with Type 1 (n=89) and Type 2 (n=60) diabetes received insulin glargine once daily for 9 months Study design
● This was an open study carried out in a diabetes practice in Germany● Of the patients with Type 1 diabetes, 72 were pre-treated with NPH insulin (once or twice daily) as their basal insulin therapy. A further 17 patients were pre-treated with NPH insulin once or twice daily andlente insulin at bedtime ● At the beginning of the study (baseline), patients with Type 1 diabetes were switched from their previous basal insulin therapy to once daily insulin glargine. Their pre-existing short-acting insulinregimen was maintained ● Patients with Type 2 diabetes were either initiated on insulin glargine as their basal insulin therapy in addition to their oral treatment, or were switched from their previous basal insulin therapy on to basalinsulin glargine within their combination regimen ● Patients were educated about their new insulin glargine treatment and about the concept of basal–bolus therapy prior to commencing the regimen Efficacy variables
was determined at the start of the study (baseline) and after 9 months of insulin glargine ● Body weight was monitored at baseline and endpoint ● In patients with Type 1 diabetes, the required insulin dose was recorded at baseline and endpoint Safety measurements
● Patients were asked to report all severe hypoglycemic events that occurred during the study period Statistical analysis
● All variables were analyzed using descriptive statistics RESULTS
Patients
● Efficacy data were available for 149 patients with Type 1 or Type 2 diabetes. Baseline characteristics Efficacy
● Insulin glargine caused a significant reduction in HbA diabetes, which was maintained throughout the study (Figure 1) ● Although there was variability in weight change over the study duration, insulin glargine caused an overall significant weight reduction (Figure 2) Please note: The trends in HbA level and weight were determined for the pooled data
Table 1. Baseline characteristics of subjects
Patients with Type 1
Patients with Type 2
Mean ± SEM
diabetes
diabetes
Mean ± SEM
Mean ± SEM
Figure 1. Reduction in mean HbA
levels in patients with Type 1 or Type 2 diabetes treated
with insulin glargine for 9 months
Patient group
Figure 2. Reduction in body weight in patients with Type 1 or Type 2 diabetes treated with
insulin glargine over a 9 month period
Body weight (kg)
Patient group
Figure 3. Reduction in mean HbA
levels in
patients with Type 1 diabetes treated with
insulin glargine
Efficacy: Type 1 subgroup
(%) 1c 7.3
Pre-treatment
● Insulin glargine caused an overall reduction in body weight in both subgroups of patients with Type 1 diabetes. However, the decrease in weight was not significant (Figure 4) ● There was a significant reduction in basal insulin dose in patients with Type 1 diabetes who were switched from either NPH insulin or NPH insulin combined with lente insulin on to insulin glargine atthe beginning of the study (Figure 5) Figure 4. Reduction in body weight in
Figure 5. Reduction in daily basal insulin
patients with Type 1 diabetes treated
dose in patients with Type 1 diabetes
with insulin glargine
treated with insulin glargine
Body weight (kg)
verage daily basal insulin glargine dose (IU)
Pre-treatment
Time point
● No adverse events or episodes of severe hypoglycemia occurred ● Mild hypoglycemic episodes were not documented CONCLUSIONS
● Treatment with insulin glargine over a 9 month period significantly improved metabolic control and
induced weight loss in patients with Type 1 or Type 2 diabetes ● Improvements in HbA levels and weight were observed in all patients, regardless of whether or not they had previously been taking NPH insulin as a basal insulin therapy ● These improvements were not accompanied by adverse events or severe hypoglycemia● Switching patients with Type 1 diabetes from NPH insulin or NPH insulin plus lente insulin to insulin glargine caused a significant reduction in basal insulin requirements, without compromising glycemic control ● This insulin dose reduction demonstrated that basal hyperinsulinization with the previous basal insulin schemes can be avoided following the switch to insulin glargine ● Educating patients about their treatment regimen and offering them a convenient, once-daily insulin may have been partly responsible for the good efficacy outcomes REFERENCES
1. Lee W and Zinman B. From insulin to insulin analogs: progress in the treatment of type 1 diabetes. Diabetes Reviews 1998; 6(2): 73–88.
2. Yki-Järvinen H, Kauppila M, Kujansuu E, Lahti J, Marjanen T, Niskanen L, et al. Comparison of insulin regimens in patients with
non-insulin-dependent diabetes mellitus. N Engl J Med 1992; 327(20): 1426–1433.
3. Heinemann L, Linkeschowa R, Rave K, Hompesch B, Sedalk M, Heise T. Time–action profile of the long-acting insulin analog insulin glargine (HOE 901) in comparison with those of NPH insulin and placebo. Diabetes Care 2000; 23: 644–649.
4. Yki-Järvinen H, Dressler A, Ziemen M. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in Type 2 diabetes. Diabetes Care 2000; 23: 1130–1136.
5. Pieber TR, Eugene-Jolchine I, Derobert E. Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes. The European Study Group of HOE 901 in type 1 diabetes. Diabetes Care 2000; 23: 157–162.

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