Japanese P III vs Voglibose and Placebo

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Inositol; Linagliptin; Voglibose

Criteria

Inclusion criteria:

1. Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.

2. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)

3. Age: >= 20 and <= 80

4. Body Mass Index (BMI) <= 40 kg/m2

Exclusion criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1

2. Impaired hepatic function

3. History of severe allergy/hypersensitivity

4. Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1

5. Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3