Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

Launched by BOEHRINGER INGELHEIM · Mar 31, 2006

Keywords

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Gender

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Eligibility criteria

• Inclusion criteria:
• Inclusion_Criteria:
• • Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
• • HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
• • HbA1c 7.5 10.0% at screening for patients treated with metformin alone
• • HbA1c 7.5 10.0% at beginning of the placebo run-in phase
• • Age \> 21 and \< 75 years
• • MI \> 25 and \< 40 kg/m2 (Body Mass Index)
• Exclusion criteria:
• Exclusion_Criteria:
• • Clinically relevant cardiovascular disease
• • Impaired hepatic function
• • Renal insufficiency or impaired renal function
• • Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
• • Treatment with insulin within 3 months prior to screening