Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Obesity

In brief

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Key facts

Study ID

NCT01306214

Run by

Boehringer Ingelheim

People needed

566

Starts

2011-02-01

Expected to finish

2013-04-01

Last updated by the study team

2014-06-17

Who can join

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

You may qualify if…

• Diagnosis of T2DM prior to informed consent
• Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin
• Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose
• HbA1c >=7.5% and <=10% at screening

You may not qualify if…

• Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
• Any contraindications to metformin according to the local label
• Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent

Where it is running

• 1245.49.10011 Boehringer Ingelheim Investigational Site — Chandler, Arizona, United States
• 1245.49.10004 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• 1245.49.10002 Boehringer Ingelheim Investigational Site — Corona, California, United States
• 1245.49.10013 Boehringer Ingelheim Investigational Site — El Cajon, California, United States
• 1245.49.10030 Boehringer Ingelheim Investigational Site — Lomita, California, United States
• 1245.49.10014 Boehringer Ingelheim Investigational Site — Spring Valley, California, United States
• 1245.49.10019 Boehringer Ingelheim Investigational Site — Westlake Village, California, United States
• 1245.49.10024 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1245.49.10018 Boehringer Ingelheim Investigational Site — Hialeah, Florida, United States
• 1245.49.10016 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1245.49.10021 Boehringer Ingelheim Investigational Site — Blue Ridge, Georgia, United States
• 1245.49.10009 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1245.49.10015 Boehringer Ingelheim Investigational Site — Evansville, Indiana, United States
• 1245.49.10023 Boehringer Ingelheim Investigational Site — Greenville, North Carolina, United States
• 1245.49.10007 Boehringer Ingelheim Investigational Site — Fargo, North Dakota, United States
• 1245.49.10006 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1245.49.10025 Boehringer Ingelheim Investigational Site — Greer, South Carolina, United States
• 1245.49.10022 Boehringer Ingelheim Investigational Site — Memphis, Tennessee, United States
• 1245.49.10003 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
• 1245.49.10001 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1245.49.10031 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1245.49.10033 Boehringer Ingelheim Investigational Site — Bountiful, Utah, United States
• 1245.49.10032 Boehringer Ingelheim Investigational Site — Salt Lake City, Utah, United States
• 1245.49.10026 Boehringer Ingelheim Investigational Site — Norfolk, Virginia, United States
• 1245.49.10005 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, 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.