Abstract
BackgroundPharmacological and clinical differences between insulin glargine and NPH insulin may translate into differences in patient reported outcomes, but existing data are equivocal.MethodsIn this 48-week, open-label, randomized, multi-center, crossover phase IV trial, insulin naïve type 2 diabetes patients with blood glucose not at target on oral hypoglycemic agents had basal insulin added to their treatment regimen. A total of 343 patients were randomized to either receive insulin glargine (n = 176; sequence A) or neutral protamine Hagedorn (NPH) insulin (n = 167; sequence B) in period 1 (weeks 1–24) and vice versa in period 2 (weeks 25–48). The primary objective was to assess patient reported outcomes using a composite Diabetes Related Quality of Life (DRQoL) score based on an unweighted Insulin Treatment Experience Questionnaire (ITEQ) score, a Problem Areas in Diabetes (PAID) questionnaire score, and the mental health score in the Short Form (SF)-12® Health Survey, analyzed by analysis of covariance (ANCOVA).ResultsPatients (mean age 62.3 ± 9.0; 39.5 % female) had a mean diabetes duration of 9.6 ± 5.9 years, a mean baseline HbA1c of 8.15 ± 0.72 %, and a mean fasting blood glucose (FBG) level of 9.37 ± 2.19 mmol/L. A total of 229 patients were available for primary endpoint evaluation (modified intention to treat population). Combining all data from both periods for each insulin treatment, on a 0–100 scale, the mean DRQoL score was 69.6 (±9.04) with insulin glargine and 70.0 (±9.40) with NPH insulin. Neither an effect of treatment with insulin glargine vs NPH insulin (p = 0.31) nor a period effect (p = 0.96), nor a sequence effect (p = 0.76) was observed using ANCOVA.ConclusionsThe results show that in a patient population with sub-optimal glycemic control at baseline, and a low target achievement rate together with a low rate of hypoglycemia, differences in the patient reported outcomes evaluated in this study were negligible between insulin glargine and NPH insulin.Trial registrationClinicaltrials.gov identifier: NCT00941369
Highlights
Pharmacological and clinical differences between insulin glargine and neutral protamine Hagedorn (NPH) insulin may translate into differences in patient reported outcomes, but existing data are equivocal
In order to allow for an accurate comparison of the two types of insulin, patients were excluded from the study if they had received treatment with any insulin within the 3 months prior to inclusion, treatment with more than two oral hypoglycemic agents (OHAs) within the 4 weeks prior to inclusion, or continuous treatment with thiazolidinediones or glucagonlike peptide (GLP)-1 receptor agonists
Demographics, and disease characteristics A total of 460 patients at 39 centers throughout Germany were screened for this study, of which 343 patients were randomized to either sequence A (n = 176) starting with insulin glargine or sequence B starting with NPH insulin (n = 167)
Summary
Pharmacological and clinical differences between insulin glargine and NPH insulin may translate into differences in patient reported outcomes, but existing data are equivocal It is well-established that achieving adequate glycemic control reduces the risk of cardiovascular complications in patients with type 2 diabetes [1, 2]. While oral antihyperglycemic treatments are often sufficient for reducing blood glucose levels in newly diagnosed patients, the progressive nature of the disease eventually requires insulin to be added to maintain glycemic control [3] Initiation of such treatment can either proceed by administration of insulin as a monotherapy, or by the addition of long-acting insulins such as neutral protamine Hagedorn (NPH) insulin or insulin glargine to the oral regimen (basal insulin supported oral therapy; BOT) [4, 5]. Reduction in lifestyle flexibility, weight gain, and management of injections all have been reported to contribute to the reluctance of patients to take insulin (psychological insulin resistance), the named differences between these two insulin regimens could be significant [12,13,14]
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