Accepted Article
Original Article Received 15-Mar-2014 Accepted 07-May-2014 Vildagliptin added to sulfonylurea improves glycemic control without hypoglycemia and weight gain in Chinese patients with type 2 diabetes mellitus
1
Wenying Yang1, Xiaoping Xing2, Xiaofeng Lv3, Yiming Li4, Jianhua Ma5, Guoyue Yuan6 on behalf of all investigators, Feifei Sun7, Wei Wang7, Michael Woloschak8, Valentina Lukashevich8, Plamen Kozlovski9, Wolfgang Kothny9 1
China-Japan Friendship Hospital, Beijing, China
2
Peking Union Medical College Hospital, Beijing, China
3
General Hospital of Beijing Military Region, Beijing, China
4
Fudan University Affiliated Huashan Hospital, Shanghai, China
5
Nanjing First Hospital, Nanjing, China
6
Affiliated Hospital of Jiangsu University, Zhenjiang, China
7
Beijing Novartis Pharma Co., Ltd., Beijing, China
8
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
9
Novartis Pharma AG, Basel, Switzerland
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/1753-0407.12169
1 This article is protected by copyright. All rights reserved.
Accepted Article
Correspondence Prof. Wenying Yang, MD, China-Japan Friendship Hospital, No. 2 Yinghua Dong Street, Chao Yang District, Hepingli Beijing, China 100029 Tel.: +86-10-84815970 Fax: 0086-10-84205716 Email: [email protected] Running title: Vildagliptin add-on to sulfonylurea in China
Abstract
Objective: To assess the efficacy and safety of vildagliptin as add-on to sulfonylurea therapy in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy. Methods: This 24-week, randomized, double-blind, placebo-controlled study compared
vildagliptin 50 mg once daily with placebo as add-on to glimepiride in T2DM patients who were inadequately controlled [HbA1c 7.5%–11.0% (58–97 mmol/mol)] on a stable dose of
sulfonylurea for ≥12 weeks before study entry. The study is registered with ClinicalTrials.gov Identifier: NCT01357252. Results: 279 patients were randomized to receive either vildagliptin (N=143) or placebo (N=136). At baseline, overall mean age was 58.5 years, body weight 68.1 kg, duration of diabetes 6.9 years and daily glimepiride dose 3.3 mg. After 24 weeks, the adjusted mean change (AMΔ) in HbA1c was 0.7% (8 mmol/mol; baseline 8.6%, 70 mmol/mol) in the vildagliptin
group and 0.2% (2 mmol/mol; baseline 8.7%, 72 mmol/mol) in the placebo group with a treatment difference of 0.5% (5 mmol/mol; P
Original Article Received 15-Mar-2014 Accepted 07-May-2014 Vildagliptin added to sulfonylurea improves glycemic control without hypoglycemia and weight gain in Chinese patients with type 2 diabetes mellitus
1
Wenying Yang1, Xiaoping Xing2, Xiaofeng Lv3, Yiming Li4, Jianhua Ma5, Guoyue Yuan6 on behalf of all investigators, Feifei Sun7, Wei Wang7, Michael Woloschak8, Valentina Lukashevich8, Plamen Kozlovski9, Wolfgang Kothny9 1
China-Japan Friendship Hospital, Beijing, China
2
Peking Union Medical College Hospital, Beijing, China
3
General Hospital of Beijing Military Region, Beijing, China
4
Fudan University Affiliated Huashan Hospital, Shanghai, China
5
Nanjing First Hospital, Nanjing, China
6
Affiliated Hospital of Jiangsu University, Zhenjiang, China
7
Beijing Novartis Pharma Co., Ltd., Beijing, China
8
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
9
Novartis Pharma AG, Basel, Switzerland
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/1753-0407.12169
1 This article is protected by copyright. All rights reserved.
Accepted Article
Correspondence Prof. Wenying Yang, MD, China-Japan Friendship Hospital, No. 2 Yinghua Dong Street, Chao Yang District, Hepingli Beijing, China 100029 Tel.: +86-10-84815970 Fax: 0086-10-84205716 Email: [email protected] Running title: Vildagliptin add-on to sulfonylurea in China
Abstract
Objective: To assess the efficacy and safety of vildagliptin as add-on to sulfonylurea therapy in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy. Methods: This 24-week, randomized, double-blind, placebo-controlled study compared
vildagliptin 50 mg once daily with placebo as add-on to glimepiride in T2DM patients who were inadequately controlled [HbA1c 7.5%–11.0% (58–97 mmol/mol)] on a stable dose of
sulfonylurea for ≥12 weeks before study entry. The study is registered with ClinicalTrials.gov Identifier: NCT01357252. Results: 279 patients were randomized to receive either vildagliptin (N=143) or placebo (N=136). At baseline, overall mean age was 58.5 years, body weight 68.1 kg, duration of diabetes 6.9 years and daily glimepiride dose 3.3 mg. After 24 weeks, the adjusted mean change (AMΔ) in HbA1c was 0.7% (8 mmol/mol; baseline 8.6%, 70 mmol/mol) in the vildagliptin
group and 0.2% (2 mmol/mol; baseline 8.7%, 72 mmol/mol) in the placebo group with a treatment difference of 0.5% (5 mmol/mol; P
