Efficacy of 500µg roflumilast once daily versus placebo over 12 weeks in patients with diabetes mellitus type 2. A double blind, parallel group, proof of concept clinical study - FORTUNA

Exclusion Criteria

• - patients diagnosed with type 1 diabetes or diabetes secondary to pancreatitis or resection of pancreas
• - patients diagnosed with hemoglobinopathies, hemolytic anemia or other diseases which interfere with HbA1c measurement
• - non-euthyroid patients or patients with a non-controlled hypo- or hyperthyroidism
• - reported gain or loss of more than 5 percent of body weight within the last 2 months prior to V0
• - treatment with any diabetes medication prior to V0
• - treatment with any weight-loss medication within 3 months prior to V0
• - treatment with any not allowed medication or nutrition additives
• - clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
• - clinically significant cardiac abnormalities (diagnosed clinically, or by X-ray/ECG) that were not related to type 2 diabetes mellitus and that required further evaluation
• - participation in a clinical study with study medication for weight loss or type 2 diabetes
• Patients were randomized after 2 weeks of the baseline period, if the following criteria were fulfilled:
• - judged to be clinically stable
• - tablet compliance ≥80 percent and ≤125 percent
• - HbA1c in the range of 7.5 percent to 8.5 percent (up to 9 percent in Mexico, Ukraine and Romania) tested at V0 by the central laboratory