Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies

Shuichi Suzuki, Tomonori Oura, Masakazu Takeuchi, Kristina S Boye, Shuichi Suzuki, Tomonori Oura, Masakazu Takeuchi, Kristina S Boye

Abstract

Background: Standardized patient-reported outcome (PRO) questionnaires can be utilized to evaluate treatment satisfaction (subjective evaluation of treatment) in patients with type 2 diabetes (T2D). These outcomes are important because they may affect patient adherence and overall study results.

Methods: PROs were evaluated in two randomized 26-week clinical trials in Japanese patients with T2D taking dulaglutide 0.75 mg (dulaglutide) once weekly; comparators were once-daily liraglutide (0.9 mg/day) and once-weekly placebo in one study and once-daily insulin glargine (glargine) in the other study. The Perceptions About Medications-Diabetes 21 Questionnaire - Japanese version (PAM-D21-J) and the Injectable Diabetes Medication Questionnaire - Japanese version (IDMQ-J) were completed by patients in both studies. These measures were both considered exploratory endpoints. All scale scores range from 0 to 100, with higher scores reflecting better outcomes.

Results: Patients reported that dulaglutide was more convenient and flexible than liraglutide (PAM-D21-J Convenience/Flexibility subscale: dulaglutide least-square mean [LSM], 84.58; liraglutide LSM, 78.94; p = .026), and that they were more satisfied with dulaglutide than with liraglutide (IDMQ-J Satisfaction subscale: dulaglutide, 75.24; liraglutide, 69.53; p = .012). Patients also reported that dulaglutide was more convenient and flexible than glargine (PAM-D21-J Convenience/Flexibility subscale: dulaglutide, 87.89; glargine, 79.22; p < .001), and that they were more satisfied with dulaglutide than with glargine (IDMQ-J Satisfaction subscale: dulaglutide, 78.86; glargine, 69.66; p < .001), and felt dulaglutide was more effective than glargine, with fewer symptoms and adverse events (PAM-D21-J Perceived Effectiveness subscale: dulaglutide, 77.61; glargine, 67.22; p < .001; Emotional Effects subscale: dulaglutide, 93.02; glargine, 89.55; p = .017; IDMQ-J Blood Glucose Control subscale: dulaglutide, 76.33; glargine, 67.57; p < .001). In addition, patients responded that dulaglutide was superior to placebo in the PAM-D21-J Convenience/Flexibility, Perceived Effectiveness, and Emotional Effects subscales and all IDMQ-J subscales (Satisfaction, Ease of Use, Lifestyle Impact, Blood Glucose Control).

Conclusions: Overall, after 26 weeks of once-weekly dulaglutide administration in Japanese patients with T2D, PROs were generally positive versus the three comparator treatments (liraglutide, glargine, and placebo), suggesting increased treatment satisfaction through better blood glucose control and convenience/flexibility and reduced negative emotional effects of diabetes.

Trial registration: ClinicalTrials.gov (monotherapy study: NCT01558271 , registered March 12, 2012; combination therapy study: NCT01584232 , registered April 23, 2012).

Keywords: Dulaglutide; Glucagon-like peptide-1; Patient-reported outcomes; Type 2 diabetes.

Figures

Fig. 1
Fig. 1
Study Design for the Monotherapy Study. D/E diet and exercise; I Injectable Diabetes Medication Questionnaire - Japanese version; LV30 follow-up visit 30 days after last study visit; OHA oral hypoglycemic agent; P Perceptions About Medications-Diabetes 21 Questionnaire - Japanese version; PRO Patient-Reported Outcomes
Fig. 2
Fig. 2
Study Design for the Combination Therapy Study. I Injectable Diabetes Medication Questionnaire - Japanese version; LV30 follow-up visit 30 days after last study visit; P Perceptions About Medications-Diabetes 21 Questionnaire - Japanese version; PRO patient-reported outcomes; SU sulfonylurea; TV telephone visit
Fig. 3
Fig. 3
Results of the PAM-D21-J and IDMQ-J at Week 26 in the Monotherapy Study. (a) PAM-D21-J at week 26 (LSM scores by treatment). (b) IDMQ-J at week 26 (LSM scores by treatment). IDMQ-J Injectable Diabetes Medication Questionnaire - Japanese version; LSM least-squares mean; PAM-D21-J Perceptions About Medications-Diabetes 21 Questionnaire - Japanese version. Dulaglutide and placebo administered once weekly; liraglutide administered once daily. For all subscales higher scores represent a more favorable state. *p < .05 vs. placebo, **p < .001 vs. placebo, #p < .05 vs. liraglutide
Fig. 4
Fig. 4
Results of the PAM-D21-J and IDMQ-J at Week 26 in the Combination Therapy Study. (a) PAM-D21-J at week 26 (LSM scores by treatment). (b) IDMQ-J at week 26 (LSM scores by treatment). IDMQ-J Injectable Diabetes Medication Questionnaire - Japanese version; LSM, least-squares mean; PAM-D21-J Perceptions About Medications-Diabetes 21 Questionnaire - Japanese version. Dulaglutide administered once weekly; insulin glargine administered once daily. For all subscales higher scores represent a more favorable state. *p < .05 vs. insulin glargine, **p < .001 vs. insulin glargine

References

    1. International Diabetes Federation . IDF diabetes atlas. 7. Brussels: International Diabetes Federation; 2015.
    1. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of diabetes. Diabetes Care. 2015;38:140–149. doi: 10.2337/dc14-2441.
    1. Japan Diabetes Society (Ed.). Treatment guide for diabetes 2014–2015. . Accessed 18 May 2017.
    1. Bradley C, Gamsu DS. Guidelines for encouraging psychological well-being: report of a Working Group of the World Health Organization Regional Office for Europe and International Diabetes Federation European Region St Vincent Declaration Action Programme for Diabetes. Diabet Med. 1994;11:510–6. doi: 10.1111/j.1464-5491.1994.tb00316.x.
    1. Peyrot M, Rubin RR, Lauritzen T, Skovlund SE, Snoek FJ, Matthews DR, et al. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005;28:2673–9. doi: 10.2337/diacare.28.11.2673.
    1. Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care. 2005;28:2543–2545. doi: 10.2337/diacare.28.10.2543.
    1. Ishii H, Iwamoto Y, Tajima N. An exploration of barriers to insulin initiation for physicians in Japan: findings from the Diabetes Attitudes, Wishes and Needs (DAWN) JAPAN study. PLoS One. 2012;7:e36361. doi: 10.1371/journal.pone.0036361.
    1. Ng CJ, Lai PS, Lee YK, Azmi SA, Teo CH. Barriers and facilitators to starting insulin in patients with type 2 diabetes: a systematic review. Int J Clin Pract. 2015;69:1050–1070. doi: 10.1111/ijcp.12691.
    1. U.S Department of Health and Human Services Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. . Accessed 18 May 2017.
    1. Barbosa CD, Balp MM, Kulich K, Germain N, Rofail D. A literature review to explore the link between treatment satisfaction and adherence, compliance, and persistence. Patient Prefer Adherence. 2012;6:39–48. doi: 10.2147/PPA.S24752.
    1. Trulicity . Prescribing information. Indianapolis: Lilly USA, LLC; 2017.
    1. Trulicity . Summary of product characteristics. Houten: Eli Lilly and Company; 2016.
    1. Trulicity Ateos. [Japan package insert] (in Japanese). Hyogo, Eli Lilly Japan KK; 2016. . Accessed 18 May 2017.
    1. Miyagawa J, Odawara M, Takamura T, Iwamoto N, Takita Y, Imaoka T. Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide is non-inferior to once-daily liraglutide and superior to placebo in Japanese patients with type 2 diabetes: a 26-week randomized phase III study. Diabetes Obes Metab. 2015;17:974–983. doi: 10.1111/dom.12534.
    1. Araki E, Inagaki N, Tanizawa Y, Oura T, Takeuchi M, Imaoka T. Efficacy and safety of once-weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once-daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open-label, phase III, non-inferiority study. Diabetes Obes Metab. 2015;17:994–1002. doi: 10.1111/dom.12540.
    1. Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016;18:419–424. doi: 10.1111/dom.12624.
    1. Hayes RP, Meldahl ML. Perceptions about medications-diabetes: further revision and validation. International Society for Quality of life research. 2009. p. A-83.
    1. Ishii H, Tsujii S, Tanaka M, Furuya M, Iburi T, Ueda R, et al. Development of insulin Delivery System questionnaire in Japanese (IDSQ-J) and reproducibility and adequacy assessment (in Japanese) J Japan Diab Soc. 2009;52:209–21.
    1. EuroQol Group EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Ikeda S, Shiroiwa T, Igarashi I, Noto S, Fukuda T, Saito S, et al. Developing a Japanese version of the EQ-5D-5L value set (in Japanese; abstract in English) J Natl Inst Public Health. 2015;64:47–55.
    1. Ishii H. Treatment satisfaction among patients with weekly exenatide, measurement with DTSQ (in Japanese) Jpn J Med Pharm Sci. 2014;71:135–43.
    1. Boye KS, Matza LS, Walter KN, Van Brunt K, Palsgrove AC, Tynan A. Utilities and disutilities for attributes of injectable treatments for type 2 diabetes. Eur J Health Econ. 2011;12:219–230. doi: 10.1007/s10198-010-0224-8.
    1. Ishii H, Anderson JH, Jr, Yamamura A, Takeuchi M, Ikeda I. Improvement of glycemic control and quality-of-life by insulin lispro therapy: assessing benefits by ITR-QOL questionnaires. Diabetes Res Clin Pract. 2008;81:169–78. doi: 10.1016/j.diabres.2008.03.020.
    1. Sakamaki H, Ikeda S, Ikegami N, Uchigata Y, Iwamoto Y, Origasa H, et al. Measurement of HRQL using EQ-5D in patients with type 2 diabetes mellitus in Japan. Value Health. 2006;9:47–53. doi: 10.1111/j.1524-4733.2006.00080.x.
    1. Reaney M, Yu M, Lakshmanan M, Pechtner V, van Brunt K. Treatment satisfaction in people with type 2 diabetes mellitus treated with once-weekly dulaglutide: data from the AWARD-1 and AWARD-3 clinical trials. Diabetes Obes Metab. 2015;17:896–903. doi: 10.1111/dom.12527.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner