Insulin glargine compared to NPH among insulin-naïve, U.S. inner city, ethnic minority type 2 diabetic patients

Abstract

Aims: We compared basal regimens of glargine or NPH among insulin-naïve, U.S. inner city, ethnic minority type 2 diabetic patients who were sub-optimally controlled on maximally tolerated doses of combination oral agents.

Methods: Eighty-five subjects were randomized to 26 weeks of open-label, add-on therapy using single doses of bedtime NPH, bedtime glargine, or morning glargine; initially through an 8-week dose titration phase, followed by a 16-week maintenance phase during which insulin doses were adjusted only to avoid symptomatic hypoglycemia.

Results: All three groups were comparable at baseline (mean HbA(1c) 9.3 ± 1.4%), and improved their HbA(1c) (to 7.8 ± 1.3%), fasting, and pre-supper glucose readings, with no significant between-group differences. Weight gain was greater with either glargine regimen (+3.1 ± 4.1 kg and +1.7 ± 4.2 kg) compared to NPH (-0.2 ± 3.9 kg), despite comparable total insulin doses. Pre-supper hypoglycemia occurred more frequently with morning glargine, but nocturnal hypoglycemia and improvements in treatment satisfaction did not differ among groups.

Conclusions: Among inner city ethnic minority type 2 diabetic patients in the U.S., we found no differences in basal glycemic control or nocturnal hypoglycemia between glargine and NPH, although glargine precipitated greater weight gain.

Trial registration: ClinicalTrials.gov NCT00686712.

Figure 1

Flowchart of Enrolled Subjects. * Protocol violations included confirmed noncompliance with insulin or concurrent oral agents for ≥ 2 weeks; SMBG occurring less than once daily for 4 or more days per week over 2 consecutive scheduled visits; or any verified falsification of SMBG readings.