Skip to main content
Top
Published in: Diabetes Therapy 4/2019

Open Access 01-08-2019 | Dulaglutid | Original Research

Clinical Efficacy and Parameters Affecting the Response to Dulaglutide Treatment in Patients with Type 2 Diabetes: A Retrospective, Real-World Data Study

Authors: Jee Hee Yoo, Yun Kyung Cho, Jiwoo Lee, Hwi Seung Kim, Yu Mi Kang, Chang Hee Jung, Joong-Yeol Park, Woo Je Lee

Published in: Diabetes Therapy | Issue 4/2019

Login to get access

Abstract

Introduction

This study aimed to investigate the efficacy and clinical factors affecting the glycemic response to dulaglutide in type 2 diabetes (T2D) in a real-world clinical setting.

Methods

We conducted a retrospective study of 234 patients at the Asan Medical Center, Republic of Korea, who had T2D and initiated dulaglutide from June 2016 to December 2017. The primary outcome was the change in glycated hemoglobin (HbA1c) concentration between baseline and 6 months after the initiation of therapy. Multivariate regression analysis was used to determine the clinical parameters contributing to a superior glycemic response to dulaglutide.

Results

The mean age of the patients was 53, and 50% were male. Their mean baseline HbA1c, body mass index and duration of diabetes were 8.8%, 27.6 kg/m2 and 10.2 years, respectively. The change in HbA1c between baseline and 6 months was − 0.92% (95% CI: − 1.1% to − 0.74%, p < 0.001). The reduction in body weight over the same period was −2.1 kg (95% CI: − 2.9 to − 1.3 kg, p < 0.001). Using multivariate regression analysis, baseline HbA1c was found to be a significant predictor of superior glycemic response to dulaglutide.

Conclusion

The use of dulaglutide was associated with a significant reduction in HbA1c and body weight over a 6-month period in a real-world clinical setting. T2D patients with higher baseline HbA1c concentrations were more likely to demonstrate good clinical responses to dulaglutide.
Appendix
Available only for authorised users
Literature
1.
go back to reference Umpierrez GE, Blevins T, Rosenstock J, Cheng C, Anderson JH, Bastyr EJ, 3rd Group EGOS. The effects of LY2189265, a long-acting glucagon-like peptide-1 analogue, in a randomized, placebo-controlled, double-blind study of overweight/obese patients with type 2 diabetes: the EGO study. Diabetes Obes Metab. 2011;13:418–25.CrossRef Umpierrez GE, Blevins T, Rosenstock J, Cheng C, Anderson JH, Bastyr EJ, 3rd Group EGOS. The effects of LY2189265, a long-acting glucagon-like peptide-1 analogue, in a randomized, placebo-controlled, double-blind study of overweight/obese patients with type 2 diabetes: the EGO study. Diabetes Obes Metab. 2011;13:418–25.CrossRef
2.
go back to reference Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, Milicevic Z. Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebo-controlled study. Diabetes Med. 2012;29:1260–7.CrossRef Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, Milicevic Z. Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebo-controlled study. Diabetes Med. 2012;29:1260–7.CrossRef
3.
go back to reference American Diabetes Association. 9 pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2019. Diabetes Care. 2019;42:S90–102.CrossRef American Diabetes Association. 9 pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2019. Diabetes Care. 2019;42:S90–102.CrossRef
4.
go back to reference Won JC, Lee JH, Kim JH, Kang ES, Won KC, Kim DJ, Lee MK. Diabetes fact sheet in Korea, 2016: an appraisal of current status. Diabetes Metab J. 2018;42:415–24.CrossRef Won JC, Lee JH, Kim JH, Kang ES, Won KC, Kim DJ, Lee MK. Diabetes fact sheet in Korea, 2016: an appraisal of current status. Diabetes Metab J. 2018;42:415–24.CrossRef
5.
go back to reference Lipscombe L, Booth G, Butalia S, Dasgupta K, Eurich DT, Goldenberg R, Khan N, MacCallum L, Shah BR, Simpson S, Diabetes Canada Clinical Practice Guidelines Expert C. Pharmacologic glycemic management of type 2 diabetes in adults. Can J Diabetes. 2018;42(Suppl 1):S88–103.CrossRef Lipscombe L, Booth G, Butalia S, Dasgupta K, Eurich DT, Goldenberg R, Khan N, MacCallum L, Shah BR, Simpson S, Diabetes Canada Clinical Practice Guidelines Expert C. Pharmacologic glycemic management of type 2 diabetes in adults. Can J Diabetes. 2018;42(Suppl 1):S88–103.CrossRef
6.
go back to reference Davies MJ, D’Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;2018(41):2669–701.CrossRef Davies MJ, D’Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;2018(41):2669–701.CrossRef
7.
go back to reference Lu JM. The role of glucagon-like peptide-1 receptor agonists in type 2 diabetes in Asia. Adv Ther. 2019;36:798–805.CrossRef Lu JM. The role of glucagon-like peptide-1 receptor agonists in type 2 diabetes in Asia. Adv Ther. 2019;36:798–805.CrossRef
8.
go back to reference Dungan KM, Povedano ST, Forst T, Gonzalez JG, Atisso C, Sealls W, Fahrbach JL. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384:1349–57.CrossRef Dungan KM, Povedano ST, Forst T, Gonzalez JG, Atisso C, Sealls W, Fahrbach JL. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384:1349–57.CrossRef
9.
go back to reference Dungan KM, Weitgasser R, Perez Manghi F, Pintilei E, Fahrbach JL, Jiang HH, Shell J, Robertson KE. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18:475–82.CrossRef Dungan KM, Weitgasser R, Perez Manghi F, Pintilei E, Fahrbach JL, Jiang HH, Shell J, Robertson KE. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18:475–82.CrossRef
10.
go back to reference Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38:2241–9.CrossRef Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38:2241–9.CrossRef
11.
go back to reference Inoue H, Tamaki Y, Kashihara Y, Muraki S, Kakara M, Hirota T, Ieiri I. Efficacy of DPP-4 inhibitors, GLP-1 analogues, and SGLT2 inhibitors as add-ons to metformin monotherapy in T2DM patients: a model-based meta-analysis. Br J Clin Pharmacol. 2019;85:393–402.CrossRef Inoue H, Tamaki Y, Kashihara Y, Muraki S, Kakara M, Hirota T, Ieiri I. Efficacy of DPP-4 inhibitors, GLP-1 analogues, and SGLT2 inhibitors as add-ons to metformin monotherapy in T2DM patients: a model-based meta-analysis. Br J Clin Pharmacol. 2019;85:393–402.CrossRef
12.
go back to reference Kugler AJ, Thiman ML. Efficacy and safety profile of once-weekly dulaglutide in type 2 diabetes: a report on the emerging new data. Diabetes Metab Syndr Obes. 2018;11:187–97.CrossRef Kugler AJ, Thiman ML. Efficacy and safety profile of once-weekly dulaglutide in type 2 diabetes: a report on the emerging new data. Diabetes Metab Syndr Obes. 2018;11:187–97.CrossRef
13.
go back to reference Shi LX, Liu XM, Shi YQ, Li QM, Ma JH, Li YB, Du LY, Wang F, Chen LL. Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: post hoc analyses of a randomized, double-blind, phase 3 study. J Diabetes Investig. 2019. https://doi.org/10.1111/jdi.13075.CrossRefPubMed Shi LX, Liu XM, Shi YQ, Li QM, Ma JH, Li YB, Du LY, Wang F, Chen LL. Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: post hoc analyses of a randomized, double-blind, phase 3 study. J Diabetes Investig. 2019. https://​doi.​org/​10.​1111/​jdi.​13075.CrossRefPubMed
14.
go back to reference Onishi Y, Oura T, Matsui A, Matsuura J, Iwamoto N. Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan. Endocr J. 2017;64:553–60.CrossRef Onishi Y, Oura T, Matsui A, Matsuura J, Iwamoto N. Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan. Endocr J. 2017;64:553–60.CrossRef
15.
go back to reference Wysham C, Guerci B, D’Alessio D, Jia N, Botros FT. Baseline factors associated with glycaemic response to treatment with once-weekly dulaglutide in patients with type 2 diabetes. Diabetes Obes Metab. 2016;18:1138–42.CrossRef Wysham C, Guerci B, D’Alessio D, Jia N, Botros FT. Baseline factors associated with glycaemic response to treatment with once-weekly dulaglutide in patients with type 2 diabetes. Diabetes Obes Metab. 2016;18:1138–42.CrossRef
16.
go back to reference Mathieu C, Del Prato S, Botros FT, Thieu VT, Pavo I, Jia N, Haupt A, Karanikas CA, Garcia-Perez LE. Effect of once weekly dulaglutide by baseline beta-cell function in people with type 2 diabetes in the AWARD programme. Diabetes Obes Metab. 2018;20:2023–8.CrossRef Mathieu C, Del Prato S, Botros FT, Thieu VT, Pavo I, Jia N, Haupt A, Karanikas CA, Garcia-Perez LE. Effect of once weekly dulaglutide by baseline beta-cell function in people with type 2 diabetes in the AWARD programme. Diabetes Obes Metab. 2018;20:2023–8.CrossRef
17.
go back to reference Kaneko S, Oura T, Matsui A, Shingaki T, Takeuchi M. Efficacy and safety of subgroup analysis stratified by baseline HbA1c in a Japanese phase 3 study of dulaglutide 0.75 mg compared with insulin glargine in patients with type 2 diabetes. Endocr J. 2017;64:1165–72.CrossRef Kaneko S, Oura T, Matsui A, Shingaki T, Takeuchi M. Efficacy and safety of subgroup analysis stratified by baseline HbA1c in a Japanese phase 3 study of dulaglutide 0.75 mg compared with insulin glargine in patients with type 2 diabetes. Endocr J. 2017;64:1165–72.CrossRef
18.
go back to reference Jones AG, McDonald TJ, Shields BM, Hill AV, Hyde CJ, Knight BA, Hattersley AT. Markers of beta-cell failure predict poor glycemic response to glp-1 receptor agonist therapy in type 2 diabetes. Diabetes Care. 2016;39:250–7.PubMed Jones AG, McDonald TJ, Shields BM, Hill AV, Hyde CJ, Knight BA, Hattersley AT. Markers of beta-cell failure predict poor glycemic response to glp-1 receptor agonist therapy in type 2 diabetes. Diabetes Care. 2016;39:250–7.PubMed
19.
go back to reference Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37:2149–58.CrossRef Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37:2149–58.CrossRef
20.
go back to reference Mody R, Grabner M, Yu M, Turner R, Kwan AYM, York W, Fernandez Lando L. Real-world effectiveness, adherence and persistence among patients with type 2 diabetes mellitus initiating dulaglutide treatment. Curr Med Res Opin. 2018;34:995–1003.CrossRef Mody R, Grabner M, Yu M, Turner R, Kwan AYM, York W, Fernandez Lando L. Real-world effectiveness, adherence and persistence among patients with type 2 diabetes mellitus initiating dulaglutide treatment. Curr Med Res Opin. 2018;34:995–1003.CrossRef
21.
go back to reference Ghosal S, Sinha B. Liraglutide and dulaglutide therapy in addition to SGLT-2 inhibitor and metformin treatment in Indian type 2 diabetics: a real world retrospective observational study. Clin Diabetes Endocrinol. 2018;4:11.CrossRef Ghosal S, Sinha B. Liraglutide and dulaglutide therapy in addition to SGLT-2 inhibitor and metformin treatment in Indian type 2 diabetics: a real world retrospective observational study. Clin Diabetes Endocrinol. 2018;4:11.CrossRef
22.
go back to reference Li Z, Zhang Y, Quan X, Yang Z, Zeng X, Ji L, Sun F, Zhan S. Efficacy and acceptability of glycemic control of glucagon-like peptide-1 receptor agonists among type 2 diabetes: a systematic review and network meta-analysis. PLoS One. 2016;11:e0154206.CrossRef Li Z, Zhang Y, Quan X, Yang Z, Zeng X, Ji L, Sun F, Zhan S. Efficacy and acceptability of glycemic control of glucagon-like peptide-1 receptor agonists among type 2 diabetes: a systematic review and network meta-analysis. PLoS One. 2016;11:e0154206.CrossRef
23.
go back to reference Gallwitz B, Dagogo-Jack S, Thieu V, Garcia-Perez LE, Pavo I, Yu M, Robertson KE, Zhang N, Giorgino F. Effect of once-weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c. Diabetes Obes Metab. 2018;20:409–18.CrossRef Gallwitz B, Dagogo-Jack S, Thieu V, Garcia-Perez LE, Pavo I, Yu M, Robertson KE, Zhang N, Giorgino F. Effect of once-weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c. Diabetes Obes Metab. 2018;20:409–18.CrossRef
24.
go back to reference Pantalone KM, Patel H, Yu M, Lando LF. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018;20:1461–9.CrossRef Pantalone KM, Patel H, Yu M, Lando LF. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018;20:1461–9.CrossRef
25.
go back to reference Ahmann A, Rodbard HW, Rosenstock J, Lahtela JT, de Loredo L, Tornoe K, Boopalan A, Nauck MA, Group NNS. Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2015;17:1056–64.CrossRef Ahmann A, Rodbard HW, Rosenstock J, Lahtela JT, de Loredo L, Tornoe K, Boopalan A, Nauck MA, Group NNS. Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2015;17:1056–64.CrossRef
26.
go back to reference Bain SC, Mosenzon O, Arechavaleta R, Bogdanski P, Comlekci A, Consoli A, Deerochanawong C, Dungan K, Faingold MC, Farkouh ME, Franco DR, Gram J, Guja C, Joshi P, Malek R, Merino-Torres JF, Nauck MA, Pedersen SD, Sheu WH, Silver RJ, Tack CJ, Tandon N, Jeppesen OK, Strange M, Thomsen M, Husain M. Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: rationale, design and patient baseline characteristics for the PIONEER 6 trial. Diabetes Obes Metab. 2018;21:499–508.CrossRef Bain SC, Mosenzon O, Arechavaleta R, Bogdanski P, Comlekci A, Consoli A, Deerochanawong C, Dungan K, Faingold MC, Farkouh ME, Franco DR, Gram J, Guja C, Joshi P, Malek R, Merino-Torres JF, Nauck MA, Pedersen SD, Sheu WH, Silver RJ, Tack CJ, Tandon N, Jeppesen OK, Strange M, Thomsen M, Husain M. Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: rationale, design and patient baseline characteristics for the PIONEER 6 trial. Diabetes Obes Metab. 2018;21:499–508.CrossRef
27.
go back to reference Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahren B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA, Harmony 6 Study G. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014;37:2317–25.CrossRef Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahren B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA, Harmony 6 Study G. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014;37:2317–25.CrossRef
28.
go back to reference Iwamoto N, Matsui A, Kazama H, Oura T. Subgroup analysis stratified by baseline pancreatic beta-cell function in a Japanese study of dulaglutide in patients with type 2 diabetes. Diabetes Ther. 2018;9:383–94.CrossRef Iwamoto N, Matsui A, Kazama H, Oura T. Subgroup analysis stratified by baseline pancreatic beta-cell function in a Japanese study of dulaglutide in patients with type 2 diabetes. Diabetes Ther. 2018;9:383–94.CrossRef
29.
go back to reference Boustani MA, Pittman I, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥ 65 and < 65 years. Diabetes Obes Metab. 2016;18:820–8.CrossRef Boustani MA, Pittman I, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥ 65 and < 65 years. Diabetes Obes Metab. 2016;18:820–8.CrossRef
Metadata
Title
Clinical Efficacy and Parameters Affecting the Response to Dulaglutide Treatment in Patients with Type 2 Diabetes: A Retrospective, Real-World Data Study
Authors
Jee Hee Yoo
Yun Kyung Cho
Jiwoo Lee
Hwi Seung Kim
Yu Mi Kang
Chang Hee Jung
Joong-Yeol Park
Woo Je Lee
Publication date
01-08-2019
Publisher
Springer Healthcare
Published in
Diabetes Therapy / Issue 4/2019
Print ISSN: 1869-6953
Electronic ISSN: 1869-6961
DOI
https://doi.org/10.1007/s13300-019-0658-7

Other articles of this Issue 4/2019

Diabetes Therapy 4/2019 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.