BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

Completed · Phase 2 · 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 pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

Key facts

Study ID

NCT00749190

Run by

Boehringer Ingelheim

People needed

495

Starts

2008-08-01

Last updated by the study team

2014-06-13

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
• Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
• HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only
• HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
• Age >=18 and <80years
• Body Mass Index (BMI) <=40 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if…

• Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
• Impaired hepatic function
• Renal insufficiency or impaired renal function
• Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
• Chronic or clinically relevant acute infections
• Current or chronic urogenital tract infection
• History of clinically relevant allergy/hypersensitivity
• Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
• Treatment with anti-obesity drugs within 3 months prior to informed consent
• Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
• Alcohol abuse or drug abuse
• Treatment with an investigational drug within 2 months prior to informed consent
• Women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial

Where it is running

• 1245.10.10001 Boehringer Ingelheim Investigational Site — Mission Viejo, California, United States
• 1245.10.10011 Boehringer Ingelheim Investigational Site — Pasadena, California, United States
• 1245.10.10028 Boehringer Ingelheim Investigational Site — Spring Valley, California, United States
• 1245.10.10027 Boehringer Ingelheim Investigational Site — Walnut Creek, California, United States
• 1245.10.10004 Boehringer Ingelheim Investigational Site — Clearwarter, Florida, United States
• 1245.10.10021 Boehringer Ingelheim Investigational Site — Melbourne, Florida, United States
• 1245.10.10005 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1245.10.10019 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1245.10.10024 Boehringer Ingelheim Investigational Site — Saint Cloud, Florida, United States
• 1245.10.10014 Boehringer Ingelheim Investigational Site — Roswell, Georgia, United States
• 1245.10.10016 Boehringer Ingelheim Investigational Site — Staten Island, New York, United States
• 1245.10.10009 Boehringer Ingelheim Investigational Site — Shelby, North Carolina, United States
• 1245.10.10006 Boehringer Ingelheim Investigational Site — Wadsworth, Ohio, United States
• 1245.10.10023 Boehringer Ingelheim Investigational Site — Norristown, Pennsylvania, United States
• 1245.10.10010 Boehringer Ingelheim Investigational Site — Clemson, South Carolina, United States
• 1245.10.10015 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1245.10.10012 Boehringer Ingelheim Investigational Site — Temple, Texas, United States
• 1245.10.10025 Boehringer Ingelheim Investigational Site — Federal Way, Washington, United States
• 1245.10.54002 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 1245.10.54004 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 1245.10.54008 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 1245.10.54006 Boehringer Ingelheim Investigational Site — Mar del Plata, Argentina
• 1245.10.54005 Boehringer Ingelheim Investigational Site — Mendoza, Argentina
• 1245.10.43002 Boehringer Ingelheim Investigational Site — Graz, Austria
• 1245.10.10026 Boehringer Ingelheim Investigational Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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