Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

• 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 (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Linagliptin

Criteria

Inclusion criteria:

1. Diabetes type 2, detectable C-peptide, HbA1c 7-10%

2. Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

Exclusion criteria:

1. Uncontrolled hyperglycemia during Run-in

2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent

3. Liver impairment; gastric surgery; medical history of cancer in last 5 years

4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation

5. Unsufficient birth control, pregnancy and nursing