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R2. Sun Hee Park/Prof. Moon Chan Choi

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1 R2. Sun Hee Park/Prof. Moon Chan Choi
Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial Lancet 2011; 377: 924–31 Bernard Zinman, Greg Fulcher, Paturi V Rao, Nihal Thomas, Lars A Endahl, Thue Johansen, Rebecka Lindh, Andrew Lewin, Julio Rosenstock, Michel Pinget, Chantal Mathieu R2. Sun Hee Park/Prof. Moon Chan Choi

2 less than ideal basal-replacement strategies
Introduction Replacement of basal insulin less than ideal basal-replacement strategies  Optimal treatment ? Insulin glargine Insulin detemir Insulin degludec New applications of basal insulin such as alternate-day or 3 times a week

3 Introduction This clinical proof-of-concept trial aimed to assess efficacy and safety of insulin degludec once a day or three times a week compared with insulin glargine once a day, in combination with metformin, in insulin-naïve people with type 2 diabetes who were inadequately controlled on oral antidiabetic drugs.

4 Methods + 28 clinics in 4 countries
~ Phase 2, randomised, open label, paralled group trial 2 week 1 week 16 week Block randomisation T2DM patients, 18~75yr HbA1C 7.0~11.0 % BMI 23~42kg/m2 Insulin naïve + oral antidiabetic drugs Insulin degludec, 3TW(M/W/F evening) Metformin titration period Metformin maintenance period Insulin degludic group A, OD(600nmol/ml) Insulin degludic group B, OD(900nmol/ml) Insulin glargine OD(600nmol/ml) + Metformin Primary efficacy endpoint : HbA1C Secondary efficacy endpoint : changes in FBS, required insulin dose, nine-point profiles of SMBG

5 Results

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7 Figure 2 : Mean HbA1c and plasma glucose concentrations by tiral intervention

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11 Conslusion Insulin degludec can provide equivalent glycaemic control to insulin glargine without new or increased rates of adverse events in insulin-naive people with type 2 diabetes.


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