OBJECTIVES: This study evaluated the experience of hypoglycemia and its impact on QoL among diabetic patients treated with MF in combination with a SU in France. METHODS: This is an observational, cross sectional multi-center survey conducted in 2005. Diabetic patients (≥ 35 years old) treated with MF in combination with SU for ≥ 6 months prior to study enrollment were included. Excluded were patients receiving insulin, treated for hepatitis or HIV, or having gestational diabetes. Case report forms were developed for collection of patients' medical record, experience of hypoglycemia, and general QoL as measured by EQ-5D. The un-weighted scoring rule was used to obtain summary EuroQoL scores. Adjusted linear regression analysis was used to evaluate the effect of hypoglycemia on patients' QoL controlling for demographic and medical characteristics. RESULTS: Four-hundred patients were recruited: average age was 62 years and 46% were female; 45% of the patients have been diagnosed with diabetes for > 7 years. One-hundred-thirty-six (34%) patients reported at least one episode of hypoglycemia during the previous 6 months: 79 (58%) experienced mild/moderate symptoms, 53 (39%) had both mild/moderate and severe symptoms, and the remaining 3% had only severe symptoms. More than half of those reported mild/moderate symptoms, and > 33% of those reported severe symptoms had ≥ 3 hypoglycemic episodes during the 6-month period prior to study enrollment. Patients with hypoglycemic episodes reported significantly lower EuroQoL scores relative to those without any symptoms (0.7 vs. 0.8, p<0.0001). After adjusting for demographic and medical characteristics (age, gender, marital status, education, co-morbid conditions) the reduction in the EuroQoL score for those with any hypoglycemic symptoms was 0.08 (p = 0.0007) units. CONCLUSIONS: More than a third of the study patients experienced one or more hypoglycemic symptoms. This study found that presence of hypoglycemic symptoms is significantly associated with lower QoL.