Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Inclusion criteria:

1. Diagnosis of diabetes mellitus prior to informed consent
2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
3. Glycosylated haemoglobin A1 >= 7.5% and <= 10%
4. Age between 18 and less than 80
5. - Body Mass index less or equal to 45

Exclusion criteria:

1. Uncontrolled hyperglycaemia during run in period
2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
3. Impaired hepatic function
4. Gastric by pass surgery
5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
6. Treatment with anti-obesity drugs
7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
8. Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial