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A Comparison of Bedtime Insulin Glargine with Bedtime Neutral Protamine Hagedorn Insulin in Patients with Type 2 Diabetes: Subgroup Analysis of Patients Taking Once-Daily Insulin in a Multicenter, Randomized, Parallel Group Study

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ABSTRACT

Background

Basal insulin is frequently administered once daily. This subgroup analysis of a multicenter, randomized, parallel study compared insulin glargine (Lantus Aventis Pharmaceuticals, Bridgewater, NJ) with neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes, evaluating only patients treated previously with once-daily NPH insulin.

Methods

Patients received bedtime insulin glargine or NPH insulin, with preprandial regular insulin. One hundred patients (mean age, 57.9 years; mean glycohemoglobin, 8.4%; mean fasting blood glucose, 167 mg/dL) were treated for up to 28 weeks.

Results

Patients treated with insulin glargine (n = 52) and NPH insulin (n = 48) achieved similar reductions from baseline in glycohemoglobin (−0.41% versus −0.46%) and fasting blood glucose (−22 mg/dL versus −22 mg/dL) at week 28. The proportion of patients reaching target fasting blood glucose (< 120 mg/dL) at 28 weeks was 34.2% with insulin glargine and 24.4% with NPH insulin. Similar proportions of patients achieved glycohemoglobin less than 7% and less than 8% in both groups. Baseline and week-28 mean daily doses of insulin glargine (27.3 IU versus 36.4 IU) were similar to NPH insulin doses (25.5 IU versus 30.2 IU). However, significantly fewer patients reported one or more episodes of hypoglycemia with insulin glargine (46.2%) versus NPH insulin (60.4%; P < 0.05). Significantly fewer patients also reported one or more symptomatic episodes confirmed by blood glucose less than 50 mg/dL with insulin glargine (17.3%) versus NPH insulin (31.3%; P < 0.005).

Conclusion

Bedtime insulin glargine is as effective as bedtime NPH insulin in improving glycemic control, with significantly less hypoglycemia.

Section snippets

Patients

The population analyzed here comprised a subset of 100 patients at 38 centers from a total population of 518 men and women 40 to 80 years of age with type 2 diabetes who had been using insulin treatment once daily for at least 3 months before study entry. The subgroup analysis included only patients who had been using once-daily basal insulin prior to randomization and were randomized to once-daily insulin glargine (n = 52) or NPH insulin (n = 48); patients who had been using multiple daily basal

Patients

Of the 100 patients treated previously with once-daily basal insulin, 52 patients received insulin glargine and 48 patients received NPH insulin. There were no differences between treatment groups with regard to baseline characteristics of patients (Table 1). The mean (± SD) glycohemoglobin levels at baseline were similar, as were the mean (± SD) fasting blood glucose levels in the insulin glargine group and the NPH insulin group.

Seven patients from the original 100 in the intent-to-treat

Discussion

The main finding in this subgroup analysis of a 28-week randomized, open-label study was that the frequency of symptomatic hypoglycemia, both unconfirmed and confirmed by blood glucose measurement, was significantly lower with insulin glargine treatment than with NPH insulin treatment. In the previously reported analysis of the total patient population, this between-treatment difference had not been statistically significant.11 As seen in the previously reported analysis of the total study

Appendix A: List of investigators and locations with patients meeting the criteria of the subgroup analysis

David S.H. Bell, Birmingham, AL; Nancy J. Bohannon and Ilyas Iliya, San Francisco, CA; John B. Buse and Joseph Largay, Chapel Hill, NC; Jackie See, Anaheim, CA; Charles Clark, Indianapolis, IN; Julio Rosenstock, Dallas, TX; Paresh Dandona, Buffalo, NY; David Kayne, Encino, CA; Mark Feinglos, Durham, NC; James Felicetta, Phoenix, AZ; Vivian Fonseca and Debra L. Simmons, Little Rock, AR; O.M. Ganda, Boston, MA; Suzanne Gebhart, Atlanta, GA; Sumer Pek, Ann Arbor, MI; Richard A. Guthrie and Lindy

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The data were presented previously at the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) congresses in 2001, and at the American Association of Clinical Endocrinology (AACE) congress in 2002.

Deceased.

The study was sponsored by Aventis Pharmaceuticals, Inc.

Drs. Vivian Fonseca, David S. Bell, Sheldon Berger, and Stephen Thomson received honoraria, consulting fees, and grant funding from Aventis Pharmaceuticals, Inc. at the time of this study. Dr. Thomas E. Mecca was employed by Hoechst Marion Roussel (now Aventis Pharmaceuticals, Inc.) at the time of this study.

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