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

Launched by BOEHRINGER INGELHEIM · Oct 15, 2009

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Eligibility criteria

• 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