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Randomized Controlled Trial
. 2015 Jun 9:13:77.
doi: 10.1186/s12955-015-0279-4.

Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents--a randomized, prospective, crossover, open clinical trial

Norbert Hermanns  1 , Bernd Kulzer  2 , Thomas Kohlmann  3 , Stephan Jacob  4 , Wolfgang Landgraf  5 , Karlheinz Theobald  6 , Thomas Haak  7
Affiliations
Randomized Controlled Trial

Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents--a randomized, prospective, crossover, open clinical trial

Norbert Hermanns et al. Health Qual Life Outcomes. .

Abstract

Background: Pharmacological and clinical differences between insulin glargine and NPH insulin may translate into differences in patient reported outcomes, but existing data are equivocal.

Methods: In 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).

Results: Patients (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.

Conclusions: The 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 registration: Clinicaltrials.gov identifier: NCT00941369.

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Figures

Fig. 1
Fig. 1
Study design. OAD, oral antidiabetic drugs / oral hypoglycemic agents corresponding to a maximum of 2 drugs out of metformin, sulfonylurea or a DPP-IV inhibitor; NPH, neutral protamine Hagedorn
Fig. 2
Fig. 2
Patient disposition. No further data are available for patients not getting randomized
Fig. 3
Fig. 3
7-point blood glucose profile (ITT). Meaurements: 1-before breakfast, 2-2 h after breakfast, 3-before lunch, 4-2 h after lunch, 5-before dinner, 7-before sleeping. Source: bgprofcurve.sas[SVN:20879] Date Extract: 08FEB2013 Table Generation: 10JUNE2013 15:21
See this image and copyright information in PMC

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