Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey – GALATA study

Abstract

Objective:

To evaluate tolerability/safety and the efficacy of the combination of vildagliptin plus metformin in a real-life population of patients with type 2 diabetes mellitus (T2DM).

Research design and methods:

This multicenter, single-arm, 6 month, observational, prospective cohort study was conducted at 39 centers across Turkey. T2DM patients on vildagliptin and metformin for ≤4 weeks were enrolled regardless of their previous antidiabetic therapy.

Main outcome measures:

Efficacy was evaluated by measuring hemoglobin A1c (HbA1c) levels. Tolerability/safety parameters evaluated included hypoglycemic events, gastrointestinal events, peripheral edema and weight gain.

Results:

This study enrolled 665 patients with a mean ± standard deviation (SD) age of 55.1 ± 10.2 years and female predominance (n = 394, 59.2%). Safety was assessed in all enrolled patients. Hypoglycemia was reported in 10 (1.5%) patients (95% confidence interval = 0.8–2.7%). Efficacy was assessed in 289 (43.5%) patients treated for 6 ± 1 months; these patients showed a mean decrease in HbA1c of 0.8% from baseline value of 7.8% (p < 0.001). The percentages of patients who achieved HbA1c targets of ≤6.5% and ≤7.0% were significantly increased, from 10.7% to 33.6% and from 22.1% to 52.6%, respectively (p < 0.001 each). The decrease in HbA1c was independent of baseline HbA1c (≤8% vs. 8–10% vs. ≥10%), age (≤65 vs. >65 years) and body mass index (<30 vs. ≥30 kg/m²) (p < 0.001 each). In total, 136 adverse events (AEs) were observed in 71 (10.7%) patients; 10 (1.5%) patients experienced hypoglycemia and gastrointestinal AEs were most commonly reported (n = 29, 4.4%).

Conclusions:

In a ‘real-life’ setting, the vildagliptin and metformin combination was associated with significant improvements in reaching target HbA1c levels, even in elderly and obese patients with T2DM. Moreover, vildagliptin and metformin demonstrated a good overall tolerability/safety profile.

Keywords: :

• DPP-4
• HbA1c
• Real-life
• Type 2 diabetes
• Vildagliptin

Transparency

Declaration of funding

The study was funded by Novartis Pharmaceuticals Turkey.

Declaration of financial/other relationships

G.A. has disclosed that he has received sponsorship from Novartis and research grants from Novartis and Novo Nordisk; he is on Astra Zeneca’s Advisory Board and is a consultant to Eli Lilly; he is also on the Speakers’ Bureau of AstraZeneca, BMS and Merck. L.K. has disclosed that she has received sponsorship and research grants from Novartis. F.A. has disclosed that she has received research grants from Novartis, Boehringer Ingelheim and Novo Nordisk. H.S.D. has disclosed that she has received sponsorship from Novartis, and has received research grants from Novartis and Sanofi Aventis; she is also on the Speakers’ Bureau of Astra Zeneca. E.T. has disclosed that he has received research grants from Novartis, and is a consultant to Novartis and Astra Zeneca. I.B.A. and E.U. have disclosed that they are employees of Novartis.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank Cagla Ayhan MD and Prof. Sule Oktay MD PhD from Kappa Consultancy Training Research Ltd, Istanbul, who provided editorial support, and Mehmet Berktas MD MICR from Kappa Consultancy Training Research Ltd, Istanbul, who performed statistical analysis funded by Novartis Pharmaceuticals Turkey.

GALATA Study Group (in alphabetical order by investigator surname): Tarik AKBER MD, Istanbul Training and Research Hospital, Istanbul; Yasemin AKDENIZ MD, Tepecik Training and Research Hospital, Izmir; Taner Fulya AKIN MD, Pamukkale University School of Medicine, Denizli; Goksun AYVAZ MD, Gazi University School of Medicine, Ankara; Nail BAMBUL MD, Goztepe Training and Research Hospital, Istanbul; Taner BAYRAKTAROGLU MD, Bulent Ecevit University School of Medicine, Zonguldak; Fatih BORLU MD, Sisli Etfal Training and Research Hospital, Istanbul; Mustafa BOZ MD, Istanbul Training and Research Hospital, Istanbul; Ergun BOZOGLU MD, Gulhane Military Medical Academy, Ankara; Mehmet Akif BUYUKBESE MD, Sutcu Imam University School of Medicine, Kahramanmaras; Aykan CANBERK MD, Istanbul University School of Medicine, Istanbul; Abdurrahman COMLEKCI MD, Dokuz Eylul University School of Medicine, Izmir; Tuncay DELIBASI MD, Diskapi Training and Research Hospital, Ankara; Serap DEMIR MD, Kocatepe University School of Medicine, Afyon; Hatice Sebile DOKMETAS MD, Cumhuriyet University School of Medicine, Sivas and Medipol University, Istanbul; Erdal ESKIOGLU MD, Numune Training and Research Hospital, Ankara; Serdar GULER MD, Ankara Training and Research Hospital, Ankara; Serpil GULKAN MD, Diskapi Training and Research Hospital, Ankara; Zeliha HEKIMSOY MD, Celal Bayar University School of Medicine, Manisa; Zuhal KARACA MD, Inonu University School of Medicine, Malatya; Lezzan KESKIN MD, Malatya State Hospital, Malatya; Muge KESKIN MD, Ankara Training and Research Hospital, Ankara; Nizameddin KOCA MD, Sevket Yılmaz Training and Research Hospital, Bursa; Hakan KORKMAZ MD, Gaziantep University School of Medicine, Gaziantep; Elif ONDER MD, Duzce University School of Medicine, Duzce; Lale OZISIK MD, Diskapi Training and Research Hospital, Ankara; Celalettin PERU MD, Bezmi Alem Foundation University Medical Faculty Hospital, Istanbul; Mustafa SAHIN MD, Diskapi Training and Research Hospital, Ankara; Fusun SAYGILI MD, Ege University School of Medicine, Izmir; Sibel SERIN MD, Umraniye Training and Research Hospital, Istanbul; Havva SEZER MD, Kocaeli University School of Medicine, Kocaeli; Gulbuz SEZGIN MD, Maltepe University School of Medicine, Istanbul; Ertugrul TASAN MD, Bezmi Alem Foundation University Medical Faculty Hospital, Istanbul; Ilker TASCI MD, Gulhane Military Medical Academy, Ankara; Turker TASLIYURT MD, Gaziosmanpasa University School of Medicine, Tokat; Ayse Nur TORUN MD, Harran University School of Medicine, Urfa; Cigdem TURA BAHADIR MD, Ondokuz Mayis University School of Medicine, Samsun; Gul GURSOY YENER MD, Ankara Training and Research Hospital, Ankara; Zerrin YIGIT MD, Istanbul University, Institute of Cardiology, Istanbul.

Previous presentations: Preliminary results, poster presentation (PDB11) at ISPOR 16th Annual European Congress, 4 November 2013, Dublin, Ireland. Final results, oral presentation (SS-009) at National Internal Medicine Congress, 17 October 2014, Antalya, Turkey.