Exenatide Twice Daily Versus Premixed Insulin Aspart 70/30 in Metformin-Treated Patients With Type 2 Diabetes A randomized 26-week study on glycemic control and hypoglycemia

被引：75

作者：

Gallwitz, Baptist ^{[2
]}

Bohmer, Michael

Segiet, Thomas

Molle, Andrea

Milek, Karsten ^{[3
]}

Becker, Bernd

Helsberg, Karin ^{[1
]}

Petto, Helmut ^{[4
]}

Peters, Natalie ^{[1
]}

Bachmann, Oliver ^{[1
]}

机构：

[1] Lilly Deutschland, Bad Homburg, Germany

[2] Univ Tubingen Hosp, Dept Med 4, Tubingen, Germany

[3] Ctr Diabetol, Hohenmolsen, Germany

[4] Eli Lilly, Vienna, Austria

来源：

DIABETES CARE | 2011年 / 34卷 / 03期

关键词：

SULFONYLUREA;

D O I：

10.2337/dc10-1900

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVE-Hypoglycemia causes recurrent morbidity in patients with type 2 diabetes. This study evaluated if exenatide twice daily (BID) was noninferior to premixed insulin aspart 70/30 BID (PIA) for glycemic control and associated with less hypoglycemia. RESEARCH DESIGN AND METHODS-In this open-label study, metformin-treated adults with type 2 diabetes were randomized to 26-week treatment with exenatide BID (4 weeks 5 mu g, then 10 mu g) or PIA. RESULTS-Exenatide BID (n = 181) was noninferior to PIA (n = 173) for A1C control (least squares [LS] mean change -1.0 vs. -1.14%; difference [95% CI] 0.14 [-0.003 to 0.291]) and associated with a lower risk for hypoglycemia (8.0 vs. 20.5%, P < 0.05). LS mean weight decreased by 4.1 kg and increased by 1.0 kg with PIA (P < 0.001). A total of 39.2 vs. 20.8% of patients reached the composite end point of A1C < 7.0%, no weight gain, and no hypoglycemia (P < 0.001; post hoc analysis). CONCLUSIONS-In metformin-treated patients, exenatide BID was noninferior to PIA for glycemic control but superior for hypoglycemia and weight control.

引用

页码：604 / 606

页数：3

共 13 条

[1] Standards of medical care in diabetes 2008 [J].

不详 .

DIABETES CARE, 2008, 31 :S12-S54

[2]

Amer Diabet Assoc, 2011, DIABETES CARE, V34, pS11, DOI [10.2337/dc10-S062, 10.2337/dc14-S081, 10.2337/dc11-S011, 10.2337/dc13-S011, 10.2337/dc13-S067, 10.2337/dc12-s064, 10.2337/dc11-S062, 10.2337/dc10-S011, 10.2337/dc12-s011]

[3] Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea [J].