Rationale, Design, and Baseline Data of the Insulin Glargine (Lantus) Versus Insulin Detemir (Levemir) Treat-To-Target (L2T3) Study: A Multinational, Randomized Noninferiority Trial of Basal Insulin Initiation in Type 2 Diabetes

Swinnen, S. G. H. A.; Snoek, Frank J.; Dain, Marie-Paule; DeVries, J. Hans; Hoekstra, J. B. L.; Holleman, F.

doi:10.1089/dia.2009.0044

Cited by 17 publications

(20 citation statements)

References 25 publications

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“…The rationale for dosing detemir twice daily and the study methods we used have been detailed before (4). In brief, this multinational, open-label trial randomized insulin-naive type 2 diabetic subjects treated for ≥3 months with stable OGLDs (including metformin ≥1 g/day) and with A1C of 7.0–10.5%, to 24-week treatment with glargine in the evening or detemir at breakfast and dinner.…”

Section: Methodsmentioning

confidence: 99%

A 24-Week, Randomized, Treat-to-Target Trial Comparing Initiation of Insulin Glargine Once-Daily With Insulin Detemir Twice-Daily in Patients With Type 2 Diabetes Inadequately Controlled on Oral Glucose-Lowering Drugs

Swinnen

Dain

Aronson³

et al. 2010

Diabetes Care

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143

129

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OBJECTIVETo determine whether glargine is noninferior to detemir regarding the percentage of patients reaching A1C <7% without symptomatic hypoglycemia ≤3.1 mmol/l.RESEARCH DESIGN AND METHODSIn this 24-week trial, 973 insulin-naive type 2 diabetic patients on stable oral glucose-lowering drugs with A1C 7.0–10.5% were randomized to glargine once daily or detemir twice daily. Insulin doses were systematically titrated.RESULTS27.5 and 25.6% of patients reached the primary outcome with glargine and detemir, respectively, demonstrating the noninferiority of glargine. Improvements in A1C were −1.46 ± 1.09% for glargine and −1.54 ± 1.11% for detemir (P = 0.149), with similar proportions of patients achieving A1C <7% (P = 0.254) but more detemir-treated patients reaching A1C <6.5% (P = 0.017). Hypoglycemia risk was similar. Weight gain was higher for glargine (difference: 0.77 kg, P < 0.001). Glargine doses were lower than detemir doses: 43.5 ± 29.0 vs. 76.5 ± 50.5 units/day (P < 0.001).CONCLUSIONSIn insulin-naive type 2 diabetic patients, glargine reached similar control as detemir, with more weight gain, but required significantly lower doses.

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Section: Methodsmentioning

confidence: 99%

A 24-Week, Randomized, Treat-to-Target Trial Comparing Initiation of Insulin Glargine Once-Daily With Insulin Detemir Twice-Daily in Patients With Type 2 Diabetes Inadequately Controlled on Oral Glucose-Lowering Drugs

Swinnen

Dain

Aronson³

et al. 2010

Diabetes Care

Self Cite

143

129

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“…It is important to note that, as described by Swinnen and coauthors, 73 the biggest predictor of success in basal insulin titration seems to be contact frequency, enforcing the titration. For patients, little and often is both easier and safer: easier because habits are more easily formed for frequently recurring events and calculation is easier from a few values rather than from many and safer because small increase steps are inherently less risky, even though the more frequent increases mean the overall speed of increase is similar.…”

Section: Appendix 1 Important Aspects Concerning Basal Insulin Titramentioning

confidence: 93%

Common Standards of Basal Insulin Titration in T2DM

Arnolds

Heise

Flacke

et al. 2013

J Diabetes Sci Technol

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Type 2 diabetes mellitus has become a worldwide major health problem, and the number of people affected is steadily increasing. Thus, not all patients suffering from the disease can be treated by specialized diabetes centers or outpatient clinics, but by primary care physicians. The latter, however, might have time constraints and have to deal with many kinds of diseases or with multimorbid patients, so their focus is not so much on lowering high blood glucose values. Thus, the physicians, as well as the patients themselves, are often reluctant to initiate and adjust insulin therapy, although basal insulin therapy is considered the appropriate strategy after oral antidiabetic drug failure, according to the latest international guidelines. A substantial number of clinical studies have shown that insulin initiation and optimization can be managed successfully by using titration algorithms-even in cases where patients themselves are the drivers of insulin titration. Nevertheless, tools and strategies are needed to facilitate this process in the daily life of both primary health care professionals and patients with diabetes.

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“…The rapid-acting analogues are insulin lispro (Humalog), insulin aspart (NovoRapid), and insulin glulisine (Apidra) [8]. The long-acting analogues are insulin glargine (Lantus), and insulin detemir (Levemir) [9]. All these analogues, except for insulin detemir, have some pharmacologically important amino acid substitutions in the primary structure of insulin (Figure 1).…”

Section: Introductionmentioning

confidence: 99%

Conformational flexibility of the pharmacologically important insulin analogues

Ksenofontova¹,

Стефанов²

2013

ABC

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Understanding the conformational flexibility of the insulin drugs is of great importance for the treatment of diabetes mellitus. Once in the body, the drug must have a certain degree of mobility within a specified period of time for the manifestation of its pharmacological properties. This mobility ensures conformational states necessary for binding with the insulin receptor and activating specific biological processes. In this work we investigated conformational flexibility of the pharmacologically important insulin analogues-insulin lispro, insulin aspart, insulin glulisine, and insulin glargine, using the molecular dynamics simulation method. This study provides new insight into the nature of behaviour of A-and B-chains. It has been found out that B-chain substitutions result in rapid acting, while long-lasting action can be achieved by substitutions in both chains. The results of this study can be used for development of new insulinbased antidiabetic drugs.

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Rationale, Design, and Baseline Data of the Insulin Glargine (Lantus) Versus Insulin Detemir (Levemir) Treat-To-Target (L2T3) Study: A Multinational, Randomized Noninferiority Trial of Basal Insulin Initiation in Type 2 Diabetes

Cited by 17 publications

References 25 publications

A 24-Week, Randomized, Treat-to-Target Trial Comparing Initiation of Insulin Glargine Once-Daily With Insulin Detemir Twice-Daily in Patients With Type 2 Diabetes Inadequately Controlled on Oral Glucose-Lowering Drugs

A 24-Week, Randomized, Treat-to-Target Trial Comparing Initiation of Insulin Glargine Once-Daily With Insulin Detemir Twice-Daily in Patients With Type 2 Diabetes Inadequately Controlled on Oral Glucose-Lowering Drugs

Common Standards of Basal Insulin Titration in T2DM

Conformational flexibility of the pharmacologically important insulin analogues

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