Dataset Information

The Effect of Linagliptin versus Metformin Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus.

ABSTRACT:

Introduction

There have been no studies directly comparing the effect of dipeptidyl peptidase-4 inhibitors with that of metformin on treatment-related quality of life (QOL) when used as first-line therapy in patients with type 2 diabetes mellitus (T2DM).

Methods

This study is a prospective, randomized, open-label, multicenter, parallel-group, comparative study. Forty-four participants who failed to achieve target glycemic control with diet and exercise therapy were randomly allocated to receive linagliptin or metformin therapy. We compared treatment-related QOL among the two groups using the Oral Hypoglycemic Agent Questionnaire, version 2 (OHA-Q version 2) and the self-administered Diabetes Therapy-Related QOL (DTR-QOL) questionnaire.

Results

After randomization, 21 patients in the linagliptin group and 22 patients in the metformin treatment group were included in the full analysis set. Biochemical parameters, incidence of adverse effects, and rate of adherence to medication were comparable between the two groups. Over the 24-week treatment period, no significant differences in overall OHA-Q scores between the groups were observed, although the subscale 1 (treatment convenience) score was significantly higher in the linagliptin group than in the metformin group. The overall DTR-QOL score did not differ between the two groups; however, the DTR-QOL scores significantly improved after 24 weeks of linagliptin treatment, but not after metformin treatment.

Conclusion

We did not find significantly better treatment-related QOL with linagliptin among Japanese patients with T2DM. In terms of treatment convenience, our data showed that linagliptin was superior to metformin.

Funding

This study was financially supported by Nippon Boehringer Ingelheim Co., Ltd. and Eli Lilly and Company. The journal's article processing fees were covered by a research fund from Juntendo University.

Clinical trial registration

UMIN000022953.

SUBMITTER: Mita T

PROVIDER: S-EPMC6349297 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundAssessing the health-related quality of life in patients with type 2 diabetes mellitus is important for evaluation of treatment outcome. The purpose of this study was to evaluate the health-related quality of life in type 2 diabetes mellitus patients and its related factors in Yazd.MethodsData were gathered by using the EuroQoL-five-dimension-5 level instrument as well as using medical records of 734 outpatients with type 2 diabetes mellitus who were referred to the largest governmental diabetes center in South of Iran, Yazd province. When appropriate, the Kruskal-Wallis test or the Wilcoxon test was used to test the difference in the health-related quality-of-life scores in each factor. Finally, the adjusted limited dependent variable mixture model was developed to investigate factors associated with health-related quality-of-life scores.ResultsThe mean and median of the EuroQoL-five-dimension-5 level index values of 717 patients who completed the questionnaires were 0.75 ± 0.006 and 0.72 ± 0.20, respectively, and those of the Visual Analogue Scale scores were 69.25 ± 0.63 and 75 ± 30, respectively. The mean scores for health-related quality of life were significantly higher for employed, educated, single, and male patients, as well as patients without comorbidities, diabetes-related complications, and hemoglobin A1c level >7%. Adjusted limited dependent variable mixture model showed that gender, age, marital status, and diabetes-related complications are significant independent predictors of EuroQoL-five-dimension-5 level index value.ConclusionThe mean scores for health-related quality of life in patients with type 2 diabetes mellitus were moderate in this study, and this finding is consistent with health-related quality-of-life scores reported in other studies conducted in the Middle East region. Therefore, health-related quality of life should be the most important consideration in the management of patients. In parallel, some factors, especially gender, should be considered to improve health-related quality of life.

Project description:IntroductionTreatment-related quality of life (QOL) is an important aspect of diabetes management. We evaluated the influence of a sodium-glucose cotransporter 2 (SGLT2) inhibitor, tofogliflozin, on treatment-related QOL in Japanese patients with type 2 diabetes mellitus (T2DM).MethodsThis is the prespecified subanalysis study of the "Using TOfogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA)" trial. Treatment-related QOL was evaluated at baseline, week 26, week 52, and week 104 after the initiation of the study using the Diabetes Therapy-Related QOL questionnaire (DTR-QOL). Among the 340 patients in the original UTOPIA study, a total of 252 patients (127, tofogliflozin group; 125, conventional treatment group) who completed the DTR-QOL questionnaire at baseline were the study subjects of the current subanalysis.ResultsThe tofogliflozin and conventional treatment groups exhibited almost comparable baseline clinical characteristics, while the use of antihypertensive drugs and lipid-lowering agents was significantly lower in the tofogliflozin treatment group than in the conventional treatment group. Tofogliflozin treatment increased the total score of DTR-QOL7 from baseline (P < 0.001), while conventional treatment did not change it. There were statistically significant differences in delta change in the total DTR-QOL7 score and DTR-QOL7 Q4, Q5, Q6, and Q7 scores from the baseline to week 104 between the treatment groups. Delta changes in HbA1c (Spearman's correlation coefficient, ρ = - 0.30, P < 0.001), fasting blood glucose (ρ = - 0.16, P = 0.031), BMI (ρ = - 0.19, P = 0.008), and waist circumference (ρ = - 0.17, P = 0.024) at week 104 were negatively associated with delta change in the total QOL7 score.ConclusionsOur data indicated that tofogliflozin treatment improved treatment-related QOL compared to conventional treatment in Japanese patients with T2DM, in accordance with the improvement of major cardiovascular risk factors.Trial registrationUMIN000017607.

Project description:BACKGROUND:Polyneuropathy is one of the commonest complications of long-standing diabetes. Progressive sensory loss can predispose patients to foot ulcer and the neuropathy oftentimes causes pain. The pain can significantly affect the quality of life of patients. OBJECTIVES:To describes the health-related quality of life of patients with type II diabetes mellitus suffering from painful diabetic peripheral neuropathy at two referral hospitals in Addis Ababa, Ethiopia, 2017. METHODS:An institution based cross sectional study with internal comparison was conducted among a sample of 220 type II diabetes mellitus patients in a 1:1 matched ratio of those with and without diabetes associated peripheral neuropathic pain. All were having regular follow up at two hospitals in Addis Ababa, Ethiopia. The Short Form (SF-36) health-related quality of life instrument was used to collect data on quality of life while basic socio-demographic and other disease specific features were collected using a structured questionnaire. Descriptive statistics was used to examine the mean scores of health related quality of life. Cronbach's alpha coefficient and Pearson's correlation coefficient were applied to estimate the internal consistency, and the level of agreement between the different domains of SF-36, respectively. To measure association between health related quality of life domains and explanatory variables, independent T-test and ANOVA were performed followed by multiple linear regression analyses. RESULTS:The health related quality of life of type II diabetes mellitus patients with peripheral neuropathic pain was poorer than those without pain in all the eight domains and the two summary scores by SF-36 (p < 0.001). Higher mean score difference was observed in Mental Component Summary Score (MCS) (14.6) compared to Physical Component Score (PCS) (9.3). Among the eight domains, the largest mean difference was found with the physical one (39.1) followed by mental health (38.2) and physical functioning (30). Pain intensity had a statistically significant negative correlation with all domains as well as the two summary scores. Younger age, a higher level of education, being single, a higher monthly income, normal body mass index, HbA1c less than seven mmo/L, absence of other diabetic complications and taking only oral hypoglycemic agents were found to predict better health related quality of life. CONCLUSION:The presence of diabetic peripheral neuropathic pain was found to negatively influence the health-related quality of life of type II diabetic patients; the greatest impact being on the 'role physical' and 'mental health' domains. Older age, presence of diabetes related complications, longer duration of illness negatively influenced the health-related quality of life.

Project description:IntroductionIn the randomized Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) 10 trial, once-daily orally administered semaglutide-the first oral glucagon-like peptide 1 receptor agonist (GLP-1RA)-was similarly tolerated with comparable (at 7 mg) or better (at 14 mg) efficacy versus the injectable GLP-1RA dulaglutide 0.75 mg. Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.MethodsThe DTR-QoL comprises 29 questions, providing four domain and total scores. Answers were converted to a score between 0 and 100, with higher scores indicating greater HRQoL. Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients. Outcomes were assessed at weeks 26 and 52.ResultsMean baseline DTR-QoL domain scores were similar between treatment arms and were generally lower (giving more scope for improvement) for "anxiety and dissatisfaction with treatment" (62.1-65.3) and "satisfaction with treatment" (53.9-57.9) than "burden on social activities and daily activities" (76.5-77.7) and "hypoglycemia" (83.5-88.2). Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg for the total score (estimated mean change from baseline [CfB] 7.3 and 8.1 vs 3.3; estimated treatment difference [ETD] 3.9 and 4.8) and the "anxiety and dissatisfaction with treatment" domain (CfB 9.7 and 10.9 vs 3.7; ETD 6.0 and 7.2) at week 52. Orally administered semaglutide 14 mg improved the "satisfaction with treatment" domain versus dulaglutide 0.75 mg (CFB 13.8 vs 5.7; ETD 8.1). DTR-QoL scores for orally administered semaglutide tended to be more durable (sustained over time) than for dulaglutide. Outcomes for the trial product estimand were similar.ConclusionOrally administered semaglutide 7 and 14 mg improved the patients' HRQoL measured by the Japanese-specific DTR-QoL instrument versus dulaglutide 0.75 mg at week 52.Trial registrationClinicalTrials.gov NCT03015220.