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      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

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          Abstract

          OBJECTIVE

          To 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 METHODS

          In 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.

          RESULTS

          27.5 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).

          CONCLUSIONS

          In 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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          Most cited references9

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          The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients.

          To compare the abilities and associated hypoglycemia risks of insulin glargine and human NPH insulin added to oral therapy of type 2 diabetes to achieve 7% HbA(1c). In a randomized, open-label, parallel, 24-week multicenter trial, 756 overweight men and women with inadequate glycemic control (HbA(1c) >7.5%) on one or two oral agents continued prestudy oral agents and received bedtime glargine or NPH once daily, titrated using a simple algorithm seeking a target fasting plasma glucose (FPG)
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            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

            Aims/hypothesis This 52-week multinational, randomised, open-label, parallel-group, non-inferiority trial compared clinical outcomes following supplementation of oral glucose-lowering drugs with basal insulin analogues detemir and glargine in type 2 diabetic patients. Methods Insulin-naive adults (n = 582, HbA1c 7.5–10.0%, BMI ≤ 40.0 kg/m2) were randomised 1:1 to receive insulin detemir or glargine once daily (evening) actively titrated to target fasting plasma glucose (FPG) ≤ 6.0 mmol/l. An additional morning insulin detemir dose was permitted if pre-dinner plasma glucose (PG) was >7.0 mmol/l after achieving FPG < 7.0 mmol/l. Due to labelling restrictions, no second glargine dose was allowed. Results Baseline HbA1c decreased from 8.6 to 7.2 and 7.1% (NS) with detemir and glargine, respectively. FPG improved from 10.8 to 7.1 and 7.0 mmol/l (NS), respectively. With detemir, 45% of participants completed the study on once daily dosing and 55% on twice daily dosing, with no difference in HbA1c. Overall, 52% of participants achieved HbA1c ≤ 7.0%: 33% (detemir) and 35% (glargine) without hypoglycaemia. Within-participant variability for self-monitored FPG and pre-dinner PG did not differ by insulin treatment, nor did the relative risk of overall or nocturnal hypoglycaemia. Modest reductions in weight gain were seen with detemir vs glargine in completers (3.0 vs 3.9 kg, p = 0.01) and in the intention-to-treat population (2.7 vs 3.5 kg, p = 0.03), primarily related to completers on once-daily detemir. Mean daily detemir dose was higher (0.78 U/kg [0.52 with once daily dosing, 1.00 U/kg with twice daily dosing]) than glargine (0.44 IU/kg). Injection site reactions were more frequent with detemir (4.5 vs 1.4%). Conclusions/interpretation Supplementation of oral agents with detemir or glargine achieves clinically important improvements in glycaemic control with low risk of hypoglycaemia. Non-inferiority was demonstrated for detemir using higher insulin doses (mainly patients on twice daily dosing); weight gain was somewhat reduced with once daily insulin detemir. ClinicalTrials.gov ID no.: NCT00283751. Electronic supplementary material The online version of this article (doi:10.1007/s00125-007-0911-x) contains supplementary material, which is available to authorised users.
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              Fear of hypoglycemia: quantification, validation, and utilization.

              Hypoglycemia can lead to various aversive symptomatic, affective, cognitive, physiological, and social consequences, which in turn can lead to the development of possible phobic avoidance behaviors associated with hypoglycemia. On the other hand, some patients may inappropriately deny or disregard warning signs of hypoglycemia. This study presents preliminary reliability and validity data on a psychometric instrument designed to quantify this fear: the hypoglycemic fear survey. The instrument was found to have internal consistency and test-retest stability, to covary with elevated glycosylated hemoglobin, and to be sensitive to a behavioral treatment program designed to increase awareness of hypoglycemia.
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                Author and article information

                Journal
                Diabetes Care
                diacare
                dcare
                Diabetes Care
                Diabetes Care
                American Diabetes Association
                0149-5992
                1935-5548
                June 2010
                3 March 2010
                : 33
                : 6
                : 1176-1178
                Affiliations
                [1] 1Department of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands;
                [2] 2Global Metabolism, sanofi-aventis, Paris, France;
                [3] 3LMC Endocrinology Centers, Toronto, Ontario, Canada;
                [4] 4Department of Cardiovascular Sciences, University of Leicester, Leicester Royal Infirmary, Leicester, U.K.;
                [5] 5Division of Endocrinology and Metabolism, McMaster University Medical Center, Hamilton, Ontario, Canada;
                [6] 6Department of Endocrinology, Diabetes and Nutrition, Charité University Medicine, Berlin, Germany;
                [7] 7Department of Medical Psychology, VU University Medical Center, Amsterdam, the Netherlands.
                Author notes
                Corresponding author: Sanne G. Swinnen, s.g.swinnen@ 123456amc.uva.nl .
                Article
                2294
                10.2337/dc09-2294
                2875419
                20200301
                53929784-4ab5-4134-9258-5b9036b4ed38
                © 2010 by the American Diabetes Association.

                Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

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                Categories
                Original Research
                Clinical Care/Education/Nutrition/Psychosocial Research

                Endocrinology & Diabetes
                Endocrinology & Diabetes

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