Exp Clin Endocrinol Diabetes 2020; 128(04): 224-230
DOI: 10.1055/a-0824-6607
Article
© Georg Thieme Verlag KG Stuttgart · New York

Real-World Adequacy of Glycaemic Control in Treatment-Naïve Greek Patients with Type 2 Diabetes Mellitus Initiating Treatment with Metformin Monotherapy at the Maximum Tolerated Dose: The Reload Study

Vasilis Tsimihodimos
1   Department of Internal Medicine, School of Medicine, University of Ioannina, Ioannina, Greece
,
Alexandra Bargiota
2   Department of Endocrinology and Metabolic Diseases, University of Thessaly School of Medicine, Larissa, Greece
,
Emmanouil M. Pagkalos
3   Private Hospital Thermi Clinic, Thessaloniki, Greece
,
Christos Manes
4   Diabetes Center, Papageorgiou General Hospital, Thessaloniki, Greece
,
Aggelos Papas
5   Diabetes Center, Venizelio General Hospital Heraklion, Crete, Greece
,
Eugenia Karamousouli
6   Merck Sharp & Dohme (MSD), Athens, Greece
,
Bernd Voss
7   MSD RBSC, Lindenplatz 1, Haar Deutschland, Germany
,
Moses S Elisaf
1   Department of Internal Medicine, School of Medicine, University of Ioannina, Ioannina, Greece
› Author Affiliations
Funding This study was funded by Merck Sharp & Dohme (MSD) Greece.
Further Information

Publication History

received 14 October 2018
revised 15 December 2018

accepted 18 December 2018

Publication Date:
22 January 2019 (online)

Abstract

Background Metformin, in the absence of contraindications or intolerance, is recommended as first-line treatment for patients with type 2 diabetes mellitus (T2DM). This observational, retrospective study assessed the real-world adequacy of glycaemic control in Greek patients with T2DM initiating metformin monotherapy at maximum tolerated dose.

Methods Included patients received metformin monotherapy for ≥24 months; relevant patient data were collected immediately prior to metformin initiation (baseline) and at other prespecified time points. The primary objective was to report, after 9 months of metformin treatment, the percentage of patients with baseline glycated haemoglobin (HbA1c) levels ≥6.5% (≥48 mmol/mol) achieving HbA1c<6.5%. Secondary objectives included the assessment of time spent with poor glycaemic control and time to treatment intensification. A sensitivity analysis assessed the percentage of patients with baseline HbA1c≥7% (≥53 mmol/mol) achieving HbA1c<7% (<53 mmol/mol).

Results Of the enrolled patients (N=316), 247 had baseline HbA1c ≥6.5%; following 9 months on metformin, 90 (36.4%) patients achieved HbA1c<6.5% (mean HbA1c change−1.3% [−14 mmol/mol]). Median time of exposure to HbA1c ≥6.5% was 23.4 months and time to treatment intensification was 28.0 months. The sensitivity analysis revealed that the proportion of patients achieving HbA1c<7.0% was 50% (mean HbA1cpy for up to 24 months. Addressing clinical inertia could improve disease outcomes and, possibly, economic burden.

 
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