Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia

Abstract

Aims: To assess the effectiveness and safety of vildagliptin/metformin initial combination therapy in drug-naïve patients with type 2 diabetes mellitus (T2DM).

Methods: INITIAL was a 24-week prospective, observational study in T2DM patients with glycated hemoglobin (HbA1c) ≥ 7.5%, and prescribed vildagliptin/metformin as initial combination therapy. The primary endpoint was change in HbA1c from baseline to week 24. Key secondary endpoints were HbA1c change from baseline to week 12, proportion of patients achieving HbA1c ≤7.0%, change in body weight at 12 and 24 weeks, change in HbA1c by sub-groups (baseline HbA1c, age, body mass index [BMI], dosage strength, co-morbidities) from baseline to week 24, and safety.

Results: A total of 532 patients were enrolled. The mean age, HbA1c, and BMI were 49.6 ± 11.27 years, 9.3 ± 1.57%, and 26.7 ± 4.50 kg/m², respectively. Cardiovascular risk factors present at baseline were dyslipidemia (30.1%), hypertension (29.7%), and obesity (20.9%). The mean reductions in HbA1c from baseline to week 12 (−1.6 ± 1.59%) and 24 (−1.9 ± 1.70%) were statistically significant (p < .001). At 24 weeks, 39.6% of patients achieved HbA1c ≤ 7.0%, and the mean body weight reduction was −1.1 ± 2.62 kg. HbA1c reductions were consistently seen from baseline to weeks 12 and 24 in the various sub-groups. Overall, 48 (9.0%) patients reported adverse events, including one hypoglycemic episode. There were no serious adverse events or deaths.

Conclusions: Overall, in a relatively young drug-naïve T2DM Asian study population with high baseline HbA1c and often associated with cardiovascular risk factors, vildagliptin/metformin combination therapy was associated with significant and clinically relevant HbA1c reduction from baseline. This effect was seen at week 12, was maintained over 24 weeks, and was accompanied by good tolerability.

Keywords:

• Initial combination therapy
• Real-life
• Type 2 diabetes mellitus
• Vildagliptin
• Asia
• Metformin

Transparency

Declaration of funding

The study was funded by Novartis Pharma AG and its respective country affiliates. Novartis Pharma AG has provided oversight on the conduct of the study, including design, collection, compilation, and analysis of data.

Declaration of financial/other interests

MC: Speaker bureau and advisory board for Novartis, MSD, Astra Zeneca, Janssen, Novo Nordisk, Sanofi, Boehringer Ingelheim and Lilly. THK: No conflicts of interest to disclose. RCM: Advisory Board and speaker for Astra Zeneca, Merck, Novo Nordisk, Eli Lilly, Novartis. PF: Speaker and Advisory board for Novartis, Novo Nordisk, Sanofi, and Eli Lilly and Investigator for Novartis, Novo Nordisk, Sanofi. KC, PHZ, and AS are employees and shareholders of Novartis Pharma AG. MC, THK, RCM, and PF are co-primary authors on this paper. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentation

Parts of the data were presented as a poster (P-774) at the 53^rd European Association for the Study of Diabetes Annual Meeting, September 11–15, 2017, Lisbon, Portugal, and oral presentation at the 19^th Asia Pacific Diabetes Conference, July 20–22, 2017, Melbourne, Australia.

Acknowledgments

The authors thank Sashi Kiran Goteti, PhD, and G. Lakshmi Deepa, PhD of Novartis Healthcare Pvt. Ltd, Hyderabad, India for providing medical writing support for the manuscript, which was funded by Novartis Pharma AG, Basel, Switzerland, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).