RESOLUTE Study in the Czech Republic: insulin glargine improves the compensation of type 2 diabetes in patients with unsatisfactory results of therapy with a combination of insulin detemir and oral antidiabetics. Results of the non‑intervention RESOLUTE Project in the Czech Republic

Česká verzia

Authors: M. Kvapil
Authors place of work: Interní klinika 2. lékařské fakulty UK a FN Motol Praha, přednosta prof. MU Dr. Milan Kvapil, CSc., MBA
Published in the journal: Vnitř Lék 2013; 59(9): 800-806
Category: Original Contributions

Summary

Introduction:
The RESOLUTE was a multinational, non interventional, 6 month prospective observational project evaluating in clinical practice, whether patients with type 2 diabetes mellitus (T2DM) inadequately controlled with detemir in combination with oral anti‑diabetic drugs (OADs) may benefit from switching to glargine. In Czech Republic 200 patients, for whom the participating physician according to their own consideration, had decided to prescribe insulin glargine in replacement of insulin detemir, were included in this project.

Objectives:
The primary endpoint was to assess the change in HbA_1c over the 6- month period in T2DM patients treated with insulin glargin after switch from insulin detemir. Secondary endpoints included the evaluation of the change in fasting plasma glucose, insulin dose, body weight over the 6-month period after starting insulin glargine , the evaluation of the number of hypoglycemia during the last month of therapy which each basal insulin and the frequency of adverse events (AE) during treatment with insulin glargine.

Results:
Insulin glargine therapy resulted in a statistically significant improvement in compensation of diabetes characterized by a mean HbA_1c decrease of about 0.82 (± 0.93) % (p < 0.001) and a mean decrease of recorded fasting glycemia about 1.91 (± 2.81) mmol/ l (p < 0.001). No significant change in the mean body weight was recorded during study [+0.12 (± 2.98) kg; p = NS]. The mean daily insulin glargine dose used at the end of the observation increased in comparison with last mean daily dose of insulin detemir [+2.99 (± 7.54) U; p < 0.001]. The improvement in glycemic control was accompanied by low risk of hypoglycemia. The percentage of patients with documented symptomatic (5.0%), nocturnal (2.5%) and severe (0%) hypoglycemia in the last month of glargine therapy was consistently lower compared with the last month of previous treatment with detemir (14.6%, 9.5% and 2.5%, respectively). Other adverse events were reported in 3.0% of patients on glargine therapy. No adverse events were considered as adverse event related to insulin glargin treatment. No serious adverse or no serious adverse events leading to treatment discontinuation or death were documented during the course of the study.

Conclusion:
Under real‑life conditions, switching from insulin detemir to once‑ daily insulin glargine in poorly controlled T2DM patients resulted in clinically relevant improvements in glycemic control without an increase in weight and hypoglycemia risk.

Key words:
diabetes mellitus type 2 – insulin glargine – insulin detemir

Zdroje

1. Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2009; 52: 17– 30.

2. Holman RR, Farmer AJ, Davies MJ et al. Three‑year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med 2009; 361: 1736– 1747.

3. Inzucchi SE, Bergenstal RM, Buse JB et al. Management of hyperglycaemia in type 2 diabetes: a patient‑ centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2012; 55: 1577– 1596.

4. SPC přípravku Lantus [online]. SÚKL [cit. 22– 12– 2012]. Dostupné z: www.sukl.cz.

5. SPC přípravku Levemir [online]. SÚKL [cit. 22– 12– 2012]. Dostupné z: www.sukl.cz.

6. DeVries JH, Meneghini L, Barnett A et al. Pooled Hypoglycemia Event Rates With Inzulin Glargine Added to Metformin (IG‑ M) from Treat‑ to‑ Target Type 2 Diabetes Mellitus (T2DM) Trials. Diabetes 2012; 61 (Suppl 1): A552– A553.

7. Home PD, Fritsche A, Schinzel S et al. Meta‑analysis of individual patient data to assess the risk of hypoglycaemia in people with type 2 diabetes using NPH insulin or insulin glargine. Diabetes Obes Metab 2010; 12: 772– 779.

8. Mullins P, Sharplin P, Yki‑ Jarvinen H et al. Negative binomial meta‑regression analysis of combined glycosylated hemoglobin and hypoglycemia outcomes across eleven Phase III and IV studies of inzulin glargine compared with neutral protamine Hagedorn inzulin in type 1 and type 2 diabetes mellitus. Clin Ther 2007; 29: 1607– 1619.

9. Swinnen SG, Simon AC, Holleman F et al. Inzulin detemir versus inzulin glargine for type 2 diabetes mellitus. Cochrane Database Syst Rev 2011: CD006383.

10. Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes (EFFICACY) [online] [cit. 26– 11– 2012]. Available from: http:/ / clinicaltrials.gov/ ct2/ show/ NCT00909480.

11. Ligthelm RJ, Borzi V, Gumprecht J et al. Importance of observational studies in clinical practice. Clin Ther 2007; 29: 1284– 1292.

12. Hajos TR, Pouwer F, de Grooth R et al. The longitudinal association between glycaemic control and health‑related quality of life following insulin therapy optimisation in type 2 diabetes patients. A prospective observational study in secondary care. Qual Life Res 2012; 8: 1359– 1365.

13. Meneghini L, Koenen C, Weng W et al. The usage of a simplified self‑ titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes – results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab 2007; 9: 902– 913.

14. Liverse AG, Rodriguez M, Czupryniak L et al. Glycaemic control of Type 2 diabetics with insulin glargine in everyday practice: Type 2 diabetic patients poorly controlled on insulin detemir therapy benefit from switching to insulin glargine. Diabetes Stoff Herz 2013; 22: 141– 147.

15. Rosenstock J, Davies M, Home PD et al. A randomised, 52‑week, treat‑ to‑ target trial comparing insulin detemir with insulin glargine when administered as add‑ on to glucose‑lowering drugs in insulin‑naive people with type 2 diabetes. Diabetologia 2008; 51: 408– 416.

16. Veneman TF, Storms FEMG, Eland IA et al. From insulin detemir to glargine: Effect on glycemic control and psychological wellbeing in patients with diabetes mellitus type 2 in daily practice. J Diabetes Mellitus 2012; 2: 101– 108.

17. The ORIGIN trial investigators. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012; 367: 319– 328.