Abstract:
BACKGROUND:Lispro Mix 25% insulin lispro/75% insulin lispro protamine (LM25) and Lispro Mix 50% insulin lispro/50% insulin lispro protamine (LM50) were compared as starter insulins in East Asian patients with type 2 diabetes. METHODS:Phase 4, open-label, randomized trial conducted in China, Japan, Korea, and Turkey. Subjects received twice-daily LM25 (n = 207) or LM50 (n = 196) for 26 weeks. The primary outcome was the HbA1c change from baseline. RESULTS:The least squares mean changes from baseline in HbA1c are -1.52% and -1.69% for LM25 and LM50, respectively, and the least squares mean difference [95% CI] is 0.17% [-0.01, 0.35]. More subjects in the LM50 group than in the LM25 group achieved HbA1c targets of <7.0% (59.7% versus 45.9%, respectively; p = 0.007). LM50 was more effective than LM25 in reducing postprandial glucose after the morning (mean difference in change from baseline, 0.56 mmol/L; p = 0.038) and evening (1.11 mmol/L; p < 0.001) meals. The reduction in fasting blood glucose was significantly greater (p = 0.046) in the LM25 group (LS mean [95% CI] change from baseline: -2.37 mmol/L [-2.68, -2.06]) than in the LM50 group (-1.99 mmol/L [-2.30, -1.68]). LM50 was more effective than LM25 in reducing HbA1c in subjects with baseline HbA1c , postprandial glucose, or carbohydrate intake levels greater than the median levels. Hypoglycemia rates and weight gain were similar between groups. CONCLUSIONS:LM25 and LM50 were noninferior to each other in improving glycemic control in Asian patients with type 2 diabetes. In addition, LM50 was more efficacious than LM25 with respect to the percentage of subjects reaching target HbA1c levels. Copyright © 2016 John Wiley & Sons, Ltd.
journal_name
Diabetes Metab Res Revjournal_title
Diabetes/metabolism research and reviewsauthors
Watada H,Su Q,Li PF,Iwamoto N,Qian L,Yang WYdoi
10.1002/dmrr.2816subject
Has Abstractpub_date
2017-01-01 00:00:00issue
1eissn
1520-7552issn
1520-7560journal_volume
33pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:To compare in atrial fibrillation patients with and without diabetes, (1) baseline characteristics, (2) additional risk factors for stroke or peripheric or visceral embolism (hypertension, previous stroke, age >75 years), (3) mortality, (4) stroke or embolism, and (5) oral anticoagulation in the year 2000. ...
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