Efficacy and Safety of BI 10773 in Combination With Insulin 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 tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Key facts

Study ID

NCT01011868

Run by

Boehringer Ingelheim

People needed

494

Starts

2009-11-01

Last updated by the study team

2014-09-30

Who can join

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

You may qualify if…

• Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
• Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea.
• Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1 (screening)
• Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
• Age > or =18 years at Visit 1 (screening)
• BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

You may not qualify if…

• Patients with poorly controlled hyperglycemia
• Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
• MI, stroke, or TIA within 3 months prior to obtaining informed consent
• Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias
• Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. Pre-menopausal women on insufficient birth control 8. Alcohol or drug abuse

Where it is running

• 1245.33.01047 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 1245.33.01060 Boehringer Ingelheim Investigational Site — Fresno, California, United States
• 1245.33.01013 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1245.33.01008 Boehringer Ingelheim Investigational Site — Los Gatos, California, United States
• 1245.33.01019 Boehringer Ingelheim Investigational Site — National City, California, United States
• 1245.33.01055 Boehringer Ingelheim Investigational Site — Paramount, California, United States
• 1245.33.01012 Boehringer Ingelheim Investigational Site — Santa Ana, California, United States
• 1245.33.01054 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1245.33.01046 Boehringer Ingelheim Investigational Site — Bradednton, Florida, United States
• 1245.33.01050 Boehringer Ingelheim Investigational Site — Brooksville, Florida, United States
• 1245.33.01059 Boehringer Ingelheim Investigational Site — Chiefland, Florida, United States
• 1245.33.01028 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1245.33.01029 Boehringer Ingelheim Investigational Site — Fleming Island, Florida, United States
• 1245.33.01048 Boehringer Ingelheim Investigational Site — Hollywood, Florida, United States
• 1245.33.01033 Boehringer Ingelheim Investigational Site — New Port Richey, Florida, United States
• 1245.33.01027 Boehringer Ingelheim Investigational Site — Atlanta, Georgia, United States
• 1245.33.01040 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 1245.33.01062 Boehringer Ingelheim Investigational Site — Lawrenceville, Georgia, United States
• 1245.33.01020 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1245.33.01044 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1245.33.01024 Boehringer Ingelheim Investigational Site — Des Moines, Iowa, United States
• 1245.33.01022 Boehringer Ingelheim Investigational Site — Saint Louis, Maryland, United States
• 1245.33.01056 Boehringer Ingelheim Investigational Site — Olive Branch, Mississippi, United States
• 1245.33.01032 Boehringer Ingelheim Investigational Site — Kansas City, Missouri, United States
• 1245.33.01014 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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