Summary:
This is a randomized, double-blind parallel group study. It will compare the safety and efficacy, and initial combination therapy with linagliptin (5mg) + pioglitazone (15mg, 30mg or 45mg) versus monotherapy with pioglitizone (15mg, 30mg or 45mg), or linagliptin 5mg once daily for 30 weeks, followed by a 54-week blinded trial period with linigliptin (5mg) + pioglitizone (30mg or 45mg) in patients with Type 2 Diabetes who have insufficient glycemic control and are on diet and exercise only.
Qualified Participants Must:
Have a diagnosis of Type 2 Diabetes
Be 18-80 years of age
Have an HbA1c of 7-10.5% on diet and exercise alone without oral antidiabetic therapy within 10 weeks of starting the trial
Qualified Participants May Receive:
Study medication, labwork, glucometer with strips/supplies at no cost and compensation for time and travel.