Corrected by: Erratum Horm Metab Res 2009; 41(12): 909-909
DOI: 10.1055/s-0029-1243513
Abstract
This report is part of the overall evaluation of using vildagliptin in the treatment
of type 2 diabetes. Here the results of a multi-center, double-blind, randomized,
active-controlled study designed to compare the efficacy and safety of two years of
monotherapy with vildagliptin 50 mg bid and gliclazide up to 320 mg/day in drug-naïve
patients with type 2 diabetes are reported. A total of 546 patients were randomized
and ∼74% of patients completed the study in each group. HbA1c values were slightly higher in the gliclazide group (HbA1c of 8.7±0.1% vs. 8.5±0.1% in the vildagliptin group). The mean reduction in HbA1c from baseline to Week 104 was −0.5% in the vildagliptin group and −0.6% in the gliclazide
group. The associated 95% confidence interval (CI) for the between-group difference
(0.13%) in mean change was (−0.06%, 0.33%). Thus, noninferiority based on an upper
limit of the CI of 0.3% was not met. In the vildagliptin group, weight increased by
0.8±0.2 kg compared to 1.6±0.2 kg in the gliclazide group (p<0.01). Mild hypoglycemia
was recorded in 0.7% of patients in the vildagliptin group and in 1.7% in the gliclazide
group. Both drugs were well tolerated. In summary, vildagliptin monotherapy resulted
in improved glycemic control in drug-naïve patients with type 2 diabetes. Although
the hypothesis of noninferiority to gliclazide was not borne out statistically, the
reductions in HbA1c were similar over a two year period and vildagliptin had significant benefits in
terms of less weight gain and less hypoglycemia.
Key words
DPP-4 - HbA1c
- GLP-1 - gliclazide
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1 * This trial (NCT00102388) is registered with ClinicalTrials. gov.
Correspondence
J. E. Foley
Clinical Research & Development
One Health Plaza
Novartis Pharmaceuticals
East Hanover
NJ
USA
Phone: +1/862/778 32 58
Fax: +1/973/781 84 96
Email: james.foley@novartis.com