Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).

Key facts

Study ID

NCT01087502

Run by

Boehringer Ingelheim

People needed

241

Starts

2010-03-01

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes mellitus
• GFR<60 ml/min
• HbA1c >=7.0% to <= 10%
• Age >= 18 years
• BMI <=45 kg/m2
• Signed and dated written informed consent

You may not qualify if…

• Myocardial infarction, stroke or TIA within 3 months prior to informed consent
• Renal impairment requiring dialysis
• Bariatric surgery
• Impaired hepatic function
• Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors
• Treatment with anti-obesity drugs
• Treatment with SU, glinides and metformin 8 weeks prior to informed consent

Where it is running

• 1218.64.10018 Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
• 1218.64.10016 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 1218.64.10015 Boehringer Ingelheim Investigational Site — Boise, Idaho, United States
• 1218.64.10002 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1218.64.10004 Boehringer Ingelheim Investigational Site — Flint, Michigan, United States
• 1218.64.10006 Boehringer Ingelheim Investigational Site — Kansas City, Missouri, United States
• 1218.64.10003 Boehringer Ingelheim Investigational Site — The Bronx, New York, United States
• 1218.64.10013 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1218.64.10020 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1218.64.10008 Boehringer Ingelheim Investigational Site — Pittsburgh, Pennsylvania, United States
• 1218.64.10009 Boehringer Ingelheim Investigational Site — Arlington, Texas, United States
• 1218.64.10005 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1218.64.10011 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1218.64.10014 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1218.64.10010 Boehringer Ingelheim Investigational Site — Tacoma, Washington, United States
• 1218.64.61005 Boehringer Ingelheim Investigational Site — Gosford, New South Wales, Australia
• 1218.64.61001 Boehringer Ingelheim Investigational Site — Liverpool, New South Wales, Australia
• 1218.64.61002 Boehringer Ingelheim Investigational Site — St Leonards, New South Wales, Australia
• 1218.64.61003 Boehringer Ingelheim Investigational Site — Adelaide, South Australia, Australia
• 1218.64.61004 Boehringer Ingelheim Investigational Site — Reservoir, Victoria, Australia
• 1218.64.20008 Boehringer Ingelheim Investigational Site — Corunna, Ontario, Canada
• 1218.64.20005 Boehringer Ingelheim Investigational Site — Hamilton, Ontario, Canada
• 1218.64.20007 Boehringer Ingelheim Investigational Site — Hamilton, Ontario, Canada
• 1218.64.20002 Boehringer Ingelheim Investigational Site — Sarnia, Ontario, Canada
• 1218.64.10007 Boehringer Ingelheim Investigational Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.