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Exp Clin Endocrinol Diabetes 2014; 122(08): 469-476
DOI: 10.1055/s-0034-1374586
Article
© J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York

Efficacy and Safety Comparison of Add-on Therapy with Liraglutide, Saxagliptin and Vildagliptin, All in Combination with Current Conventional Oral Hypoglycemic Agents Therapy in Poorly Controlled Chinese Type 2 Diabetes

C.-J. Li   *
1   Department of Endocrinology, 2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics, Key Laboratory of Hormone and Development (Ministry of Health), Metabolic Disease Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
,
Q. Yu   *
1   Department of Endocrinology, 2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics, Key Laboratory of Hormone and Development (Ministry of Health), Metabolic Disease Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
,
P. Yu
1   Department of Endocrinology, 2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics, Key Laboratory of Hormone and Development (Ministry of Health), Metabolic Disease Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
,
Q.-M. Zhang
1   Department of Endocrinology, 2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics, Key Laboratory of Hormone and Development (Ministry of Health), Metabolic Disease Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
,
M. Ding
1   Department of Endocrinology, 2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics, Key Laboratory of Hormone and Development (Ministry of Health), Metabolic Disease Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
,
X.-J. Liu
1   Department of Endocrinology, 2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics, Key Laboratory of Hormone and Development (Ministry of Health), Metabolic Disease Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
,
D.-M. Yu
1   Department of Endocrinology, 2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics, Key Laboratory of Hormone and Development (Ministry of Health), Metabolic Disease Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
› Author Affiliations
Further Information

Publication History

received 26 November 2013
first decision 04 March 2014

accepted 31 March 2014

Publication Date:
16 May 2014 (online)

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Abstract

Objective

To compare the efficacy and safety of adding liraglutide, saxagliptin and vildagliptin to current therapy in Chinese type 2 diabetes subjects with poor glycemic control.

Method:

A 24-week, randomized, open-label, parallel clinical trial was performed. A total 178 patients completed the trial who had been randomly assigned to add-on once daily liraglutide (1.2 mg/day injected subcutaneously), to saxagliptin (5 mg once daily) or to vildagliptin (50 mg twice daily). Glycosylated hemoglobin (HbA1c) values, fasting and postprandial blood glucose (FBG and P2BG), body weight, body mass index (BMI), episodes of hypoglycemia and adverse events were evaluated.

Results:

Over the 24-week treatment period, greater lowering of mean of HbA1c was achieved with 1.2 mg liraglutide (−1.50%, 95% CI [−1.67, −1.34]) than with saxagliptin (−1.23%, 95% CI [−1.36, −1.11]) and vildagliptin (−1.25%, 95% CI [−1.37, −1.13]). There was no significant between-group difference of percentages of subjects who reached a target HbA1c<7.0%, but significantly more subjects with liraglutide achieved HbA1c≤6.5% compared with saxagliptin and vildagliptin. The mean reduction of FBG value from baseline was 2.23 mmol/L with liraglutide, much greater than 1.83 mmol/L with saxagliptin (p=0.013), but similar to 2.03 mmol/L with ­vildaglitpin group. As to the P2BG value, greater reductions was found with liraglutide (−4.80 mmol/L) than −3.56 mmol/L with saxagliptin (p=0.000) and −3.57 mmol/L with vildagliptin (p=0.000). Moreover, greater mean reductions of body weight and BMI with liraglutide (−6.0 kg and −2.1 kg/m2) were achieved than with saxagliptin and vildagliptin (both p<0.001), whereas no significant difference was found between saxagliptin and vildagliptin group. The incidence of hypoglycemia was recorded low and similar in each treatment group. Nausea was more common with liraglutide (27%) than with saxagliptin (3.2%) and vildagliptin (5.2%), but no significant between-group difference was reported in other AEs.

Conclusions:

Adding liraglutide demonstrated superiority to saxagliptin and vildagliptin for reductions of HbA1c and weight loss in Chinese subjects with T2DM who had inadequate glycemic control with conventional oral hypoglycemic agents. These findings support the add-on of liraglutide could offer notable advantages over DPP-4 inhibitors in both efficacy and safety.

Key words

type 2 diabetes - GLP-1 - DPP-4 inhibitor

* Chun-Jun Li and Qian Yu contributed equally to this study.


 

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