Comprehensive Add on Study in Japan

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Glycoside Hydrolase Inhibitors; Linagliptin; Metformin

Criteria

Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus

2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Exclusion criteria:

1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism

2. Impaired hepatic function

3. Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1

4. Treatment with anti-obesity drugs