ArticlesA 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
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
References (18)
- et al.
Insulins today and beyond
Lancet
(2001) Control of glycaemia
Baillieres Clin Endocrinol Metab
(1993)- et al.
Global burden of diabetes, 1995–2025: prevalence, numerical estimates, and projections
Diabetes Care
(1998) Standards of medical care for patients with diabetes mellitus. ADA Position Statement
Diabetes Care
(2001)The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group
N Engl J Med
(1993)Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group
Lancet
(1998)- et al.
Appropriate insulin regimes for type 2 diabetes: a multicenter randomized crossover study
Diabetes Care
(2000) Banting Lecture
Hypoglycemia: the limiting factor in the management of IDDM. Diabetes
(1994)- et al.
Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro
Diabetes
(2000)
Cited by (0)
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.