- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01011868
Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes
September 24, 2014 updated by: Boehringer Ingelheim
A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
494
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalborg, Denmark
- 1245.33.45006 Boehringer Ingelheim Investigational Site
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Aarhus C, Denmark
- 1245.33.45001 Boehringer Ingelheim Investigational Site
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Aarhus C, Denmark
- 1245.33.45011 Boehringer Ingelheim Investigational Site
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Aarhus C, Denmark
- 1245.33.45013 Boehringer Ingelheim Investigational Site
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Gentofte, Denmark
- 1245.33.45004 Boehringer Ingelheim Investigational Site
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Hillerød, Denmark
- 1245.33.45008 Boehringer Ingelheim Investigational Site
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Hvidovre, Denmark
- 1245.33.45002 Boehringer Ingelheim Investigational Site
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København NV, Denmark
- 1245.33.45003 Boehringer Ingelheim Investigational Site
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Bondy Cedex, France
- 1245.33.3301A Boehringer Ingelheim Investigational Site
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Corbeil Essonnes, France
- 1245.33.3302A Boehringer Ingelheim Investigational Site
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La Rochelle Cedex 1, France
- 1245.33.3305A Boehringer Ingelheim Investigational Site
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Marseille, France
- 1245.33.3306A Boehringer Ingelheim Investigational Site
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Montbrison, France
- 1245.33.3308A Boehringer Ingelheim Investigational Site
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Nanterre Cedex, France
- 1245.33.3309A Boehringer Ingelheim Investigational Site
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Nantes, France
- 1245.33.3310A Boehringer Ingelheim Investigational Site
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Narbonne Cedex, France
- 1245.33.3304A Boehringer Ingelheim Investigational Site
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Saint Mandé, France
- 1245.33.3303A Boehringer Ingelheim Investigational Site
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Dublin, Ireland
- 1245.33.35302 Boehringer Ingelheim Investigational Site
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Dublin, Ireland
- 1245.33.35303 Boehringer Ingelheim Investigational Site
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Dublin, Ireland
- 1245.33.35304 Boehringer Ingelheim Investigational Site
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Daejeon, Korea, Republic of
- 1245.33.82008 Boehringer Ingelheim Investigational Site
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Gwangju, Korea, Republic of
- 1245.33.82007 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1245.33.82001 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1245.33.82003 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1245.33.82004 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1245.33.82005 Boehringer Ingelheim Investigational Site
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Wonju, Korea, Republic of
- 1245.33.82006 Boehringer Ingelheim Investigational Site
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Yangsan, Korea, Republic of
- 1245.33.82002 Boehringer Ingelheim Investigational Site
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Aveiro, Portugal
- 1245.33.35104 Boehringer Ingelheim Investigational Site
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Coimbra, Portugal
- 1245.33.35101 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
- 1245.33.35102 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
- 1245.33.35106 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
- 1245.33.35107 Boehringer Ingelheim Investigational Site
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Bath, United Kingdom
- 1245.33.44001 Boehringer Ingelheim Investigational Site
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Birmingham, United Kingdom
- 1245.33.44003 Boehringer Ingelheim Investigational Site
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Blackburn, United Kingdom
- 1245.33.44006 Boehringer Ingelheim Investigational Site
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Dorking, United Kingdom
- 1245.33.44005 Boehringer Ingelheim Investigational Site
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Headington, United Kingdom
- 1245.33.44009 Boehringer Ingelheim Investigational Site
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Leicester, United Kingdom
- 1245.33.44008 Boehringer Ingelheim Investigational Site
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Liverpool, United Kingdom
- 1245.33.44004 Boehringer Ingelheim Investigational Site
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Wembley, United Kingdom
- 1245.33.44007 Boehringer Ingelheim Investigational Site
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Whitstable, United Kingdom
- 1245.33.44002 Boehringer Ingelheim Investigational Site
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Wymondham, United Kingdom
- 1245.33.44010 Boehringer Ingelheim Investigational Site
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Alabama
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Birmingham, Alabama, United States
- 1245.33.01014 Boehringer Ingelheim Investigational Site
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Arizona
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Phoenix, Arizona, United States
- 1245.33.01047 Boehringer Ingelheim Investigational Site
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California
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Fresno, California, United States
- 1245.33.01060 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
- 1245.33.01013 Boehringer Ingelheim Investigational Site
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Los Gatos, California, United States
- 1245.33.01008 Boehringer Ingelheim Investigational Site
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National City, California, United States
- 1245.33.01019 Boehringer Ingelheim Investigational Site
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Paramount, California, United States
- 1245.33.01055 Boehringer Ingelheim Investigational Site
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Santa Ana, California, United States
- 1245.33.01012 Boehringer Ingelheim Investigational Site
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Colorado
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Denver, Colorado, United States
- 1245.33.01054 Boehringer Ingelheim Investigational Site
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Florida
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Bradednton, Florida, United States
- 1245.33.01046 Boehringer Ingelheim Investigational Site
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Brooksville, Florida, United States
- 1245.33.01050 Boehringer Ingelheim Investigational Site
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Chiefland, Florida, United States
- 1245.33.01059 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
- 1245.33.01028 Boehringer Ingelheim Investigational Site
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Fleming Island, Florida, United States
- 1245.33.01029 Boehringer Ingelheim Investigational Site
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Hollywood, Florida, United States
- 1245.33.01048 Boehringer Ingelheim Investigational Site
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New Port Richey, Florida, United States
- 1245.33.01033 Boehringer Ingelheim Investigational Site
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Georgia
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Atlanta, Georgia, United States
- 1245.33.01027 Boehringer Ingelheim Investigational Site
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Decatur, Georgia, United States
- 1245.33.01040 Boehringer Ingelheim Investigational Site
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Lawrenceville, Georgia, United States
- 1245.33.01062 Boehringer Ingelheim Investigational Site
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Illinois
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Chicago, Illinois, United States
- 1245.33.01020 Boehringer Ingelheim Investigational Site
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Chicago, Illinois, United States
- 1245.33.01044 Boehringer Ingelheim Investigational Site
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Iowa
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Des Moines, Iowa, United States
- 1245.33.01024 Boehringer Ingelheim Investigational Site
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Maryland
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St. Louis, Maryland, United States
- 1245.33.01022 Boehringer Ingelheim Investigational Site
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Mississippi
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Olive Branch, Mississippi, United States
- 1245.33.01056 Boehringer Ingelheim Investigational Site
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Missouri
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Kansas City, Missouri, United States
- 1245.33.01032 Boehringer Ingelheim Investigational Site
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Nebraska
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Omaha, Nebraska, United States
- 1245.33.01017 Boehringer Ingelheim Investigational Site
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Nevada
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Las Vegas, Nevada, United States
- 1245.33.01043 Boehringer Ingelheim Investigational Site
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New York
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New Hartford, New York, United States
- 1245.33.01051 Boehringer Ingelheim Investigational Site
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North Carolina
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Greensboro, North Carolina, United States
- 1245.33.01007 Boehringer Ingelheim Investigational Site
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Jacksonville, North Carolina, United States
- 1245.33.01003 Boehringer Ingelheim Investigational Site
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Salisbury, North Carolina, United States
- 1245.33.01016 Boehringer Ingelheim Investigational Site
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Statesville, North Carolina, United States
- 1245.33.01005 Boehringer Ingelheim Investigational Site
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Wilmington, North Carolina, United States
- 1245.33.01038 Boehringer Ingelheim Investigational Site
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Winston-Salem, North Carolina, United States
- 1245.33.01026 Boehringer Ingelheim Investigational Site
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Ohio
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Cincinnati, Ohio, United States
- 1245.33.01025 Boehringer Ingelheim Investigational Site
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Columbus, Ohio, United States
- 1245.33.01001 Boehringer Ingelheim Investigational Site
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Oklahoma
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Tulsa, Oklahoma, United States
- 1245.33.01031 Boehringer Ingelheim Investigational Site
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Oregon
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Eugene, Oregon, United States
- 1245.33.01045 Boehringer Ingelheim Investigational Site
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Pennsylvania
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Altoona, Pennsylvania, United States
- 1245.33.01018 Boehringer Ingelheim Investigational Site
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Carlisle, Pennsylvania, United States
- 1245.33.01041 Boehringer Ingelheim Investigational Site
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Landsdale, Pennsylvania, United States
- 1245.33.01042 Boehringer Ingelheim Investigational Site
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South Carolina
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Greer, South Carolina, United States
- 1245.33.01004 Boehringer Ingelheim Investigational Site
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Mt. Pleasant, South Carolina, United States
- 1245.33.01036 Boehringer Ingelheim Investigational Site
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Seneca, South Carolina, United States
- 1245.33.01035 Boehringer Ingelheim Investigational Site
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Tennessee
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Kingsport, Tennessee, United States
- 1245.33.01058 Boehringer Ingelheim Investigational Site
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Memphis, Tennessee, United States
- 1245.33.01037 Boehringer Ingelheim Investigational Site
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Texas
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Dallas, Texas, United States
- 1245.33.01023 Boehringer Ingelheim Investigational Site
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Dallas, Texas, United States
- 1245.33.01030 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
- 1245.33.01006 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
- 1245.33.01011 Boehringer Ingelheim Investigational Site
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Sugar Land, Texas, United States
- 1245.33.01002 Boehringer Ingelheim Investigational Site
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Utah
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Salt Lake City, Utah, United States
- 1245.33.01049 Boehringer Ingelheim Investigational Site
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Virginia
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Norfolk, Virginia, United States
- 1245.33.01015 Boehringer Ingelheim Investigational Site
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Richmond, Virginia, United States
- 1245.33.01009 Boehringer Ingelheim Investigational Site
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Washington
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Federal Way, Washington, United States
- 1245.33.01010 Boehringer Ingelheim Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States
- 1245.33.01061 Boehringer Ingelheim Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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)
Exclusion criteria:
- 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
6. 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BI 10773 low dose
Patients receive BI 10773 low dose daily
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BI 10773 low dose
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Experimental: BI 10773 high dose
Patients receive BI 10773 high dose daily
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BI 10773 placebo
BI 10773 high dose
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Placebo Comparator: placebo
Patients receive placebo to match BI 10773 daily
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BI 10773 placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment
Time Frame: Baseline and 18 weeks
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Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment
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Baseline and 18 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment
Time Frame: Baseline and 18, 54 and 78 weeks
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Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment
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Baseline and 18, 54 and 78 weeks
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Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Time Frame: Baseline, 18, 54 and 78 weeks
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Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
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Baseline, 18, 54 and 78 weeks
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Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Time Frame: Baseline, 18, 54 and 78 weeks
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Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
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Baseline, 18, 54 and 78 weeks
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Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment
Time Frame: Baseline, 54 and 78 weeks
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Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment
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Baseline, 54 and 78 weeks
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Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment
Time Frame: Baseline, 18, 54, 78 weeks
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Change from baseline in body weight after 18, 54 and 78 weeks of treatment
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Baseline, 18, 54, 78 weeks
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Change From Baseline in Body Weight at Follow-up
Time Frame: Baseline and 82 weeks
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Change from baseline in body weight at follow up (82 weeks)
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Baseline and 82 weeks
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Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment
Time Frame: Baseline, 54 and 78 weeks
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Change from baseline in HbA1c after 54 and 78 weeks of treatment
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Baseline, 54 and 78 weeks
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The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment
Time Frame: Baseline, 18, 54 and 78 weeks
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The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0%
After 18, 54, and 78 weeks of treatment
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Baseline, 18, 54 and 78 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmed Hypoglycemic Events
Time Frame: During the course of the study (82 weeks)
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Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value ≤70 ml/dL or where assistance was required.
Symptomatic hypoglycemic events were to be reported as adverse events.
Investigator-defined hypoglycaemia adverse events include all events that investigator marked as 'Hypoglycaemic event' in CRFs, regardless of the reported term or blood glucose value.
It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g.
dizziness, hyperhidrosis, and asthenia).
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During the course of the study (82 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
November 10, 2009
First Submitted That Met QC Criteria
November 10, 2009
First Posted (Estimate)
November 11, 2009
Study Record Updates
Last Update Posted (Estimate)
September 30, 2014
Last Update Submitted That Met QC Criteria
September 24, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1245.33
- 2009-013668-38 (EudraCT Number: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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