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

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 during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Key facts

Study ID

NCT00954447

Run by

Boehringer Ingelheim

People needed

1263

Starts

2009-08-01

Last updated by the study team

2013-12-30

Who can join

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

You may qualify if…

• Diabetes type 2, detectable C-peptide, HbA1c 7-10%
• Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

You may not qualify if…

• Uncontrolled hyperglycemia during Run-in
• Myocardial infarction, stroke or TIA within 3 months prior to informed consent
• Liver impairment; gastric surgery; medical history of cancer in last 5 years
• Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
• Unsufficient birth control, pregnancy and nursing

Where it is running

• 1218.36.01051 Boehringer Ingelheim Investigational Site — Escondido, California, United States
• 1218.36.01065 Boehringer Ingelheim Investigational Site — Fresno, California, United States
• 1218.36.01021 Boehringer Ingelheim Investigational Site — Greenbrae, California, United States
• 1218.36.01013 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1218.36.01048 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1218.36.01058 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1218.36.01008 Boehringer Ingelheim Investigational Site — Santa Ana, California, United States
• 1218.36.01056 Boehringer Ingelheim Investigational Site — Waterbury, Connecticut, United States
• 1218.36.01054 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1218.36.01035 Boehringer Ingelheim Investigational Site — Inverness, Florida, United States
• 1218.36.01010 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1218.36.01042 Boehringer Ingelheim Investigational Site — New Port Richey, Florida, United States
• 1218.36.01063 Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
• 1218.36.01037 Boehringer Ingelheim Investigational Site — Ponte Vedra, Florida, United States
• 1218.36.01032 Boehringer Ingelheim Investigational Site — Saint Cloud, Florida, United States
• 1218.36.01049 Boehringer Ingelheim Investigational Site — St. Petersburg, Florida, United States
• 1218.36.01036 Boehringer Ingelheim Investigational Site — Atlanta, Georgia, United States
• 1218.36.01047 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 1218.36.01009 Boehringer Ingelheim Investigational Site — Roswell, Georgia, United States
• 1218.36.01055 Boehringer Ingelheim Investigational Site — Honolulu, Hawaii, United States
• 1218.36.01014 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1218.36.01011 Boehringer Ingelheim Investigational Site — Paducah, Kentucky, United States
• 1218.36.01034 Boehringer Ingelheim Investigational Site — City of Saint Peters, Missouri, United States
• 1218.36.01040 Boehringer Ingelheim Investigational Site — Kansas City, Missouri, United States
• 1218.36.01043 Boehringer Ingelheim Investigational Site — Escondido, California, United States

Full record on ClinicalTrials.gov

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