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Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.
Diabetes Obes Metab. 2014 May; 16(5):403-9.DO

Abstract

AIM

The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add-on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control.

METHODS

A multicentre, double-blind, placebo-controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks.

RESULTS

After 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was -1.01% with vildagliptin (baseline 8.75%) and -0.25% with placebo (baseline 8.80%), with a between-treatment difference of -0.76% (p < 0.001). Significantly more patients on vildagliptin achieved the HbA1c target <7% (28.3% vs. 5.6%; p < 0.001). The difference in fasting plasma glucose reduction between vildagliptin and placebo was -1.13 mmol/l (p < 0.001). In subgroup of patients with baseline HbA1c ≤8%, vildagliptin reduced HbA1c by 0.74% from baseline 7.82% (between-treatment difference: -0.97%; p < 0.001) with significantly more patients achieving the HbA1c target <7% (38.6% vs. 13.9%; p = 0.014). Vildagliptin was well tolerated with low incidence of hypoglycaemia, slightly higher than with placebo (5.1% vs. 1.9%) and no clinically relevant weight gain.

CONCLUSIONS

Vildagliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin plus glimepiride combination. The addition of vildagliptin was well tolerated with low risk of hypoglycaemia and weight gain. This makes vildagliptin an attractive treatment option for patients failing on metformin plus SU particularly in patients with baseline HbA1c ≤8%.

Authors+Show Affiliations

Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24199686

Citation

Lukashevich, V, et al. "Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Dual Combination of Metformin and Sulphonylurea." Diabetes, Obesity & Metabolism, vol. 16, no. 5, 2014, pp. 403-9.
Lukashevich V, Del Prato S, Araga M, et al. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014;16(5):403-9.
Lukashevich, V., Del Prato, S., Araga, M., & Kothny, W. (2014). Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes, Obesity & Metabolism, 16(5), 403-9. https://doi.org/10.1111/dom.12229
Lukashevich V, et al. Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Dual Combination of Metformin and Sulphonylurea. Diabetes Obes Metab. 2014;16(5):403-9. PubMed PMID: 24199686.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. AU - Lukashevich,V, AU - Del Prato,S, AU - Araga,M, AU - Kothny,W, Y1 - 2013/12/02/ PY - 2013/09/18/received PY - 2013/10/29/revised PY - 2013/10/29/accepted PY - 2013/11/9/entrez PY - 2013/11/10/pubmed PY - 2015/1/24/medline KW - DPP-4 inhibitor KW - glimepiride KW - metformin KW - oral antidiabetic drug KW - type 2 diabetes KW - vildagliptin SP - 403 EP - 9 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 16 IS - 5 N2 - AIM: The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add-on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control. METHODS: A multicentre, double-blind, placebo-controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks. RESULTS: After 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was -1.01% with vildagliptin (baseline 8.75%) and -0.25% with placebo (baseline 8.80%), with a between-treatment difference of -0.76% (p < 0.001). Significantly more patients on vildagliptin achieved the HbA1c target <7% (28.3% vs. 5.6%; p < 0.001). The difference in fasting plasma glucose reduction between vildagliptin and placebo was -1.13 mmol/l (p < 0.001). In subgroup of patients with baseline HbA1c ≤8%, vildagliptin reduced HbA1c by 0.74% from baseline 7.82% (between-treatment difference: -0.97%; p < 0.001) with significantly more patients achieving the HbA1c target <7% (38.6% vs. 13.9%; p = 0.014). Vildagliptin was well tolerated with low incidence of hypoglycaemia, slightly higher than with placebo (5.1% vs. 1.9%) and no clinically relevant weight gain. CONCLUSIONS: Vildagliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin plus glimepiride combination. The addition of vildagliptin was well tolerated with low risk of hypoglycaemia and weight gain. This makes vildagliptin an attractive treatment option for patients failing on metformin plus SU particularly in patients with baseline HbA1c ≤8%. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/24199686/Efficacy_and_safety_of_vildagliptin_in_patients_with_type_2_diabetes_mellitus_inadequately_controlled_with_dual_combination_of_metformin_and_sulphonylurea_ L2 - https://doi.org/10.1111/dom.12229 DB - PRIME DP - Unbound Medicine ER -