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CC BY-NC-ND 4.0 · Exp Clin Endocrinol Diabetes 2021; 129(09): 666-673
DOI: 10.1055/a-0899-5118
Article

Effectiveness of Insulin Degludec in Thai Patients with Diabetes Mellitus: Real-World Evidence From a Specialized Diabetes Center

Yotsapon Thewjitcharoen
Diabetes and Thyroid Center, Theptarin Hospital, Bangkok, Thailand
,
Nalin Yenseung
Diabetes and Thyroid Center, Theptarin Hospital, Bangkok, Thailand
,
Areeya Malidaeng
Diabetes and Thyroid Center, Theptarin Hospital, Bangkok, Thailand
,
Siriwan Butadej
Diabetes and Thyroid Center, Theptarin Hospital, Bangkok, Thailand
,
Phawinpon Chotwanvirat
Diabetes and Thyroid Center, Theptarin Hospital, Bangkok, Thailand
,
Sirinate Krittiyawong
Diabetes and Thyroid Center, Theptarin Hospital, Bangkok, Thailand
,
Chattip Thammawiwat
Diabetes and Thyroid Center, Theptarin Hospital, Bangkok, Thailand
,
Thep Himathongkam
Diabetes and Thyroid Center, Theptarin Hospital, Bangkok, Thailand
› Author Affiliations Funding: This work was supported by the grant for promoting research in Theptarin Hospital (Grant No. 1/2560). The funders had no role in the manuscript writing, editing, approval, or decision to publish.
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Abstract

Background Insulin degludec, an ultra-long-acting insulin analogue, has been available in Thailand since October 2016. Although clinical trial results revealed less hypoglycemia, data from real-world settings is limited especially in Asian patients. This study aimed to evaluate prospectively the real-world effectiveness, safety, quality of life (QOL) and patient satisfaction with insulin degludec among Thai patients with diabetes mellitus (DM).

Methods From October 2016 to September 2017, all patients who had started insulin degludec for at least 3 months were observed and evaluated at baseline, 3, 6, and 12 months. QOL was assessed using WHOQOL-BREF-THAI and level of satisfaction was measured by 7-point Likert scale. Glycemic fluctuation from paired iPro2 continuous glucose monitoring (CGM) obtained 4–6 weeks apart were also evaluated from a subset of patients with T1DM who switched from insulin glargine to insulin degludec.

Results A total of 55 patients (T2DM 76.4%, females 54.5%, mean age 57.1±16.1 years, duration of diabetes 16.7±8.8 years, BMI 27.3±5.5 kg/m2, baseline A1C 9.3±2.3%, median duration of treatment 8 months) were included in the study. In T1DM patients (n=13), the overall mean A1C reduction at 12 months was 0.5% with minimal weight gain of 0.9 kgs at 12 months. In T2DM patients (n=42), the overall mean A1C reduction at 12 months was 0.8% with minimal weight loss of 0.4 kgs at 12 months. The proportion of T1DM patients who could achieve optimal glycemic control increased slightly from 14.3 to 18.2% but the proportion of T2DM patients who could achieve optimal glycemic control increased from 30.8 to 53.8%. Patient satisfaction showed a sustained improvement throughout the duration of study. In four T1DM patients who had paired CGM data, insulin degludec provided greater reductions in glycemic variability endpoints with increased time-in-range when compared with previous insulin glargine.

Discussion Our data suggested that the effectiveness of insulin degludec was consistent with the results seen in clinical trials with lower risk of patients-reported hypoglycemia, and a significant improvement in glycemic control. Patients also reported higher treatment satisfaction. More long-term and cost-effectiveness data are needed to establish the role of this ultra-long-acting insulin in real-world settings.

Key words

insulin degludec - real-world evidence - Thai patients - continuous glucose monitoring - glycemic variability


Publication History

Received: 02 March 2019
Received: 12 April 2019

Accepted: 24 April 2019

Article published online:
09 October 2019

© 2019. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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  • References

  • 1 Nathan DM. DCCT/EDIC Research Group. The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: overview. Diabetes Care 2014; 37: 9-16
    CrossrefPubMedGoogle Scholar
  • 2 Frier BM. Hypoglycaemia in diabetes mellitus: epidemiology and clinical implications. Nat Rev Endocrinol 2014; 10: 711-722
    CrossrefPubMedGoogle Scholar
  • 3 Heise T, Nosek L, Bøttcher SG. et al. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in Type 2 diabetes. Diabetes Obes Metab 2012; 14: 944-950
    CrossrefPubMedGoogle Scholar
  • 4 Tibaldi JM. Evolution of insulin development: focus on key parameters. Adv Ther 2012; 29: 590-619
    CrossrefPubMedGoogle Scholar
  • 5 Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet 2014; 53: 787-800
    CrossrefPubMedGoogle Scholar
  • 6 Heller S, Buse J, Fisher M. et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN® Basal-Bolus Type 1): a phase 3, randomised, open-label, treat to-target non-inferiority trial. Lancet 2012; 379: 1489-1497
    CrossrefPubMedGoogle Scholar
  • 7 Garber AJ, King AB, Del Prato S. et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN® Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012; 379: 1498-1507
    CrossrefPubMedGoogle Scholar
  • 8 Zinman B, Philis-Tsimikas A, Cariou B. et al. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN® Once Long). Diabetes Care 2012; 35: 2464-2471
    CrossrefPubMedGoogle Scholar
  • 9 Marso SP, McGuire DK, Zinman B. et al. DEVOTE Study Group Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med 2017; 377: 723-732
    CrossrefPubMedGoogle Scholar
  • 10 Sherman RE, Anderson SA, Dal Pan GJ. et al. Real-world evidence - what is it and what can it tell us?. N Engl J Med 2016; 375: 2293-2297
    CrossrefPubMedGoogle Scholar
  • 11 Kaku K, Wolden ML, Hyllested-Winge J. et al. Insulin degludec in clinical practice: A review of Japanese Real-World Data. Diabetes Ther 2017; 8: 189-195
    CrossrefPubMedGoogle Scholar
  • 12 Chan WB, Chen JF, Goh SY. et al. Challenges and unmet needs in basal insulin therapy: lessons from the Asian experience. Diabetes Metab Syndr Obes 2017; 10: 521-532
    CrossrefPubMedGoogle Scholar
  • 13 Mahatnirunjul S, Tuntipivatanakul W, Pumpisanchai W. Comparison of the WHOQOL-100 and the WHOQOL-BREF (26 items). J Ment Health Thai 1998; 5: 4-15
    PubMedGoogle Scholar
  • 14 Inchiostro S, Candido R, Cavalot F. How can we monitor glycaemic variability in the clinical setting?. Diabetes Obes Metab 2013; 15 Suppl 2 13-16
    CrossrefPubMedGoogle Scholar
  • 15 Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart. Diabet Med 2006; 23: 879-886
    CrossrefPubMedGoogle Scholar
  • 16 Galasso S, Facchinetti A, Bonora BM. et al. Switching from twice-daily glargine or detemir to once-daily degludec improves glucose control in type 1 diabetes. An observational study. Nutr Metab Cardiovasc Dis 2016; 26: 1112-1119
    CrossrefPubMedGoogle Scholar
  • 17 Onishi Y, Iwamoto Y, Yoo SJ. et al. Insulin degludec compared with insulin glargine in insulin-naïve patients with type 2 diabetes: a 26-week, randomized, controlled, Pan-Asian, treat-to-target trial. J Diabetes Investig 2013; 4: 605-612
    CrossrefPubMedGoogle Scholar
  • 18 Fidler C, Elmelund Christensen T. et al. Hypoglycemia: an overview of fear of hypoglycemia, quality-of-life, and impact on costs. J Med Econ 2011; 14: 646-655
    CrossrefPubMedGoogle Scholar
  • 19 Khunti K, Alsifri S, Aronson R. et al. Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study. Diabetes Obes Metab 2016; 18: 907-915
    CrossrefPubMedGoogle Scholar
  • 20 Rodbard D. Continuous glucose monitoring: A review of recent studies demonstrating improved glycemic outcomes. Diabetes Technol Ther 2017; 19: S25-S37
    CrossrefPubMedGoogle Scholar
  • 21 Zinman B, Marso SP, Poulter NR. et al. Day-to-day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2). Diabetologia 2018; 61: 48-57
    CrossrefPubMedGoogle Scholar
  • 22 Diana CH, Oscar M, Ana M. et al. Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes. J Clin Transl Endocrinol 2018; 12: 8-12
    PubMedGoogle Scholar
  • 23 Yotsapon T, Sirinate K, Ekgaluck W. et al. Clinical characteristics and outcomes of the oldest old people with type 2 diabetes - perspective from a tertiary diabetes center in Thailand. BMC Endocr Disord 2016; 16: 30
    CrossrefPubMedGoogle Scholar
  • 24 Oishi A, Makita N, Manaka K. et al. Successful glycemic control with three times a week degludec injection by medical staff for an elderly hemodialysis patient with type 2 diabetes. Diabetol Int 2015; 7: 95-99
    CrossrefPubMedGoogle Scholar
  • 25 Nagai Y, Murakami M, Igarashi K. et al. Efficacy and safety of thrice-weekly insulin degludec in elderly patients with type 2 diabetes assessed by continuous glucose monitoring. Endocr J 2016; 63: 1099-1106
    CrossrefPubMedGoogle Scholar
  • 26 Goh SG, Rusli BN, Khalid BA. Development and validation of the Asian Diabetes Quality of Life (AsianDQOL) Questionnaire. Diabetes Res Clin Pract 2015; 108: 489-498
    CrossrefPubMedGoogle Scholar
  • 27 Zhong Y, Lin PJ, Cohen JT. et al. Cost-utility analyses in diabetes: a systematic review and implications from real-world evidence. Value Health 2015; 18: 308-314
    CrossrefPubMedGoogle Scholar
  • 28 Beran D, Ewen M, Laing R. Constraints and challenges in access to insulin: a global perspective. Lancet Diabetes. Lancet Diabetes Endocrinol 2016; 4: 275-285
    CrossrefPubMedGoogle Scholar
  • 29 Ericsson A, Pollock RF, Hunt B. et al. Evaluation of the cost-utility of insulin degludec vs insulin glargine in Sweden. J Med Econ 2013; 16: 1442-1452
    CrossrefPubMedGoogle Scholar
  • 30 Evans M, Wolden M, Gundgaard J. et al. Cost-effectiveness of insulin degludec compared with insulin glargine in a basal-bolus regimen in patients with type 1 diabetes mellitus in the UK. J Med Econ 2015; 18: 56-68
    CrossrefPubMedGoogle Scholar