Treatment satisfaction and quality of life using an early insulinization strategy with insulin glargine compared to an adjusted oral therapy in the management of Type 2 diabetes: The Canadian INSIGHT Study

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Abstract

The objective was to compare the impact on treatment satisfaction (TS) and quality of life (QoL) of early insulinization with glargine versus adjusting oral antidiabetic drug (OAD) therapy in people with Type 2 diabetes with uncontrolled glycemia.

TS and QoL were assessed at baseline, weeks 12 and 24 within the Canadian INSIGHT, a randomized 24-week trial of Type 2 patients.

A total of 366 patients randomized to either the insulin glargine arm (n = 182) or the adjusted OAD therapy arm (n = 184) completed both questionnaires.

At baseline, TS and QoL were similar in both groups. A1c reduction was greater in the insulin glargine arm. TS improved from baseline in both treatment arms; however, there was greater increase with insulin glargine + OAD. Perceived frequency of hypoglycemia and hypoglycemia were lower at week 24, with no differences between the two groups. Perceived frequency of hyperglycemia improved with glargine at week 12, and no difference was found at 24 weeks. Finally, QoL improved in both groups, but significantly more with glargine at both weeks 12 and 24.

Improving glucose control by adding insulin glargine to OAD therapy had a positive impact on TS and general QoL without complaints related to hypoglycemia.

Introduction

Diabetes can have a profound effect on quality of life. It is one of the most psychologically demanding of the chronic diseases [1]. It is essential that the evaluation of new treatments for diabetes include an assessment of their impact on treatment satisfaction and quality of life. Ideally, improved metabolic control should not occur at the expense of an adverse effect on well-being.

Patients with Type 2 diabetes mellitus are usually treated initially with oral antidiabetic drugs (OADs), and insulin is typically withheld until patients are unresponsive to a combination of lifestyle approaches and 1 or more OADs including metformin, insulin secretagogues, alpha glucosidase inhibitors or thiazolidinediones. Recently, there has been a renewed interest in the role of early insulin therapy for the management of Type 2 diabetes in an effort to meet increasingly stringent diabetes guidelines, promoting near-normal A1c levels [2], [3]. Concerns among patients and their providers regarding an adverse effect on quality of life may be a factor in the traditional approach of withholding insulin until other therapies are no longer effective.

Basal insulin secretion remains constant throughout the day and is essential for glucose regulation in both the liver and the peripheral insulin target tissues (muscle and adipose tissue) [4]. Insulin glargine (Lantus®) is a safe, soluble long-acting insulin preparation that can be administered once daily and provides a reliable level of basal insulin coverage over 24 h [5]. Trials have shown that using insulin glargine to target near normal glucose levels is associated with lower rates of hypoglycemia than NPH insulin [6], [7]. Most recently, the Canadian INSIGHT (Implementing New Strategies with Insulin Glargine for Hyperglycemia Treatment) trial showed that when insulin naïve patients with Type 2 diabetes and inadequate glycemic control on 0, 1 or 2 oral agents are treated by adding insulin glargine to their regimen, they more rapidly achieve a HbA1c < 6.5% than adding and adjusting OAD therapy. As a secondary endpoint, TS and QOL were assessed using two validated psychometric instruments—the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and Audit of Diabetes Dependent Quality of Life (ADDQoL) Questionnaire.

Section snippets

Patients and methods

A detailed description of the protocol and main results has been previously published [8]. Briefly 19 endocrinologists or experts selected 34 family physicians for a mentor/preceptor relationship, facilitating insulin initiation. The family physicians had little expertise with insulin initiation and were provided with education and resources to help them feel comfortable with the therapy. Study subjects included in this analysis are a subset of the intent-to-treat population. They were aged

Questionnaires

Self-administered diabetes treatment satisfaction (DTSQ) and quality of life (QoL) questionnaires were administered at baseline, weeks 12 and 24. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) measures satisfaction with treatment regimen (six items), Perceived Frequency of Hyperglycemia (one item) and Perceived Frequency of Hypoglycemia (one item) over the past few weeks [9]. The Audit of Diabetes-Dependent Quality of Life (ADDQoL) is designed to measure individuals’ perception of the

Statistical analysis

The primary TS and QOL outcome variables were the changes from baseline to week 12 and baseline to week 24 in the DTSQ and ADDQoL scores. Although the sample size calculation was based on the primary clinical variable of change in A1c, prior studies suggested that the sample size was more than sufficient to detect meaningful differences in change between bedtime insulinization with glargine and optimization of OAD therapy with no insulin in psychological outcomes [11]. Between treatment arms

Results

A total of 366 of the 405 subjects (90.4%) randomized to either the insulin glargine + OAD arm (n = 182) or the adjusted OAD therapy arm (n = 184) completed both the DTSQ and the ADDQoL questionnaires at baseline, and at 12 and/or 24 weeks. Patients’ characteristics were similar at baseline for age, sex, age at onset, duration of diabetes, glucose control (A1c, FPG), and comorbidities (Table 1). These results are restricted to the patients who completed both questionnaires. At baseline, TS and QoL

Discussion

The evaluation of new treatments for diabetes often overlooks an assessment of treatment satisfaction and impact on quality of life. These evaluations are particularly important when comparative treatments may be equally efficacious, as satisfaction is likely to lead to patient preferences for one treatment over another. Increased patient satisfaction with a treatment has also been shown to be related to adherence to prescription regimens.

Studies have examined the impact of different insulin

Conclusions

The Canadian INSIGHT trial suggests that improving glucose control by adding insulin glargine to OAD therapy in patients with Type 2 diabetes had a positive impact on TS and general QoL (using the ADDQoL) without complaints related to hypoglycemia. The study should help allay concerns among patients and their providers that an early insulinization strategy in Type 2 diabetes will have an adverse effect on quality of life.

Conflict of interest

There are no conflicts of interest.

Acknowledgements

Financial support: Dr. Gerstein holds the McMaster University Population Health Institute Chair in Diabetes Research. Dr. Harris holds the Ian McWhittney Chair for Studies in Family Medicine. The study was supported by a grant from Sanofi-Aventis Canada Inc.

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