Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773 placebo; Drug: BI 10773 low dose; Drug: BI 10773 high dose

• Registration Number: NCT01011868
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2012-05
• Results First Submitted: 2014-05-16
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-24
• Last Update Submitted: 2014-09-24
• Results First Posted: 2014-09-30
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	BI 10773 placebo	Patients receive placebo to match BI 10773 daily
BI 10773 low dose	BI 10773 low dose	Patients receive BI 10773 low dose daily
BI 10773 high dose	BI 10773 high dose	Patients receive BI 10773 high dose daily
BI 10773 high dose	BI 10773 placebo	Patients receive BI 10773 high dose daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment	Baseline and 18 weeks	Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment	Baseline, 54 and 78 weeks	Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment
Change From Baseline in Body Weight at Follow-up	Baseline and 82 weeks	Change from baseline in body weight at follow up (82 weeks)
Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment	Baseline, 18, 54 and 78 weeks	Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment	Baseline, 54 and 78 weeks	Change from baseline in HbA1c after 54 and 78 weeks of treatment
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	Baseline, 18, 54 and 78 weeks	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
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment	Baseline and 18, 54 and 78 weeks	Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment
Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment	Baseline, 18, 54 and 78 weeks	Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment	Baseline, 18, 54, 78 weeks	Change from baseline in body weight after 18, 54 and 78 weeks of treatment

Trial Locations

Locations (99)

1245.33.01060 Boehringer Ingelheim Investigational Site; 🇺🇸 Fresno, 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

1245.33.01050 Boehringer Ingelheim Investigational Site; 🇺🇸 Brooksville, Florida, United States

1245.33.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 Santa Ana, California, United States

1245.33.01028 Boehringer Ingelheim Investigational Site; 🇺🇸 Clearwater, Florida, United States

1245.33.01046 Boehringer Ingelheim Investigational Site; 🇺🇸 Bradednton, Florida, United States

1245.33.01059 Boehringer Ingelheim Investigational Site; 🇺🇸 Chiefland, Florida, United States

1245.33.01029 Boehringer Ingelheim Investigational Site; 🇺🇸 Fleming Island, Florida, United States

1245.33.01033 Boehringer Ingelheim Investigational Site; 🇺🇸 New Port Richey, Florida, United States

1245.33.01048 Boehringer Ingelheim Investigational Site; 🇺🇸 Hollywood, Florida, United States

1245.33.01040 Boehringer Ingelheim Investigational Site; 🇺🇸 Decatur, Georgia, United States

1245.33.01062 Boehringer Ingelheim Investigational Site; 🇺🇸 Lawrenceville, Georgia, United States

1245.33.01024 Boehringer Ingelheim Investigational Site; 🇺🇸 Des Moines, Iowa, United States

1245.33.01056 Boehringer Ingelheim Investigational Site; 🇺🇸 Olive Branch, Mississippi, United States

1245.33.01051 Boehringer Ingelheim Investigational Site; 🇺🇸 New Hartford, New York, United States

1245.33.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Greensboro, North Carolina, United States

1245.33.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Jacksonville, North Carolina, United States

1245.33.01016 Boehringer Ingelheim Investigational Site; 🇺🇸 Salisbury, North Carolina, United States

1245.33.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Statesville, North Carolina, United States

1245.33.01038 Boehringer Ingelheim Investigational Site; 🇺🇸 Wilmington, North Carolina, United States

1245.33.01031 Boehringer Ingelheim Investigational Site; 🇺🇸 Tulsa, Oklahoma, United States

1245.33.01045 Boehringer Ingelheim Investigational Site; 🇺🇸 Eugene, Oregon, United States

1245.33.01042 Boehringer Ingelheim Investigational Site; 🇺🇸 Landsdale, Pennsylvania, United States

1245.33.01018 Boehringer Ingelheim Investigational Site; 🇺🇸 Altoona, Pennsylvania, United States

1245.33.01041 Boehringer Ingelheim Investigational Site; 🇺🇸 Carlisle, Pennsylvania, United States

1245.33.01036 Boehringer Ingelheim Investigational Site; 🇺🇸 Mt. Pleasant, South Carolina, United States

1245.33.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Greer, South Carolina, United States

1245.33.01035 Boehringer Ingelheim Investigational Site; 🇺🇸 Seneca, South Carolina, United States

1245.33.01058 Boehringer Ingelheim Investigational Site; 🇺🇸 Kingsport, Tennessee, United States

1245.33.01037 Boehringer Ingelheim Investigational Site; 🇺🇸 Memphis, Tennessee, United States

1245.33.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 Sugar Land, Texas, United States

1245.33.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 Norfolk, Virginia, United States

1245.33.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States

1245.33.01010 Boehringer Ingelheim Investigational Site; 🇺🇸 Federal Way, Washington, United States

1245.33.45006 Boehringer Ingelheim Investigational Site; 🇩🇰 Aalborg, Denmark

1245.33.45001 Boehringer Ingelheim Investigational Site; 🇩🇰 Aarhus C, Denmark

1245.33.45011 Boehringer Ingelheim Investigational Site; 🇩🇰 Aarhus C, Denmark

1245.33.45013 Boehringer Ingelheim Investigational Site; 🇩🇰 Aarhus C, Denmark

1245.33.45008 Boehringer Ingelheim Investigational Site; 🇩🇰 Hillerød, Denmark

1245.33.45002 Boehringer Ingelheim Investigational Site; 🇩🇰 Hvidovre, Denmark

1245.33.3302A Boehringer Ingelheim Investigational Site; 🇫🇷 Corbeil Essonnes, France

1245.33.45003 Boehringer Ingelheim Investigational Site; 🇩🇰 København NV, Denmark

1245.33.3301A Boehringer Ingelheim Investigational Site; 🇫🇷 Bondy Cedex, France

1245.33.3305A Boehringer Ingelheim Investigational Site; 🇫🇷 La Rochelle Cedex 1, France

1245.33.3306A Boehringer Ingelheim Investigational Site; 🇫🇷 Marseille, France

1245.33.3308A Boehringer Ingelheim Investigational Site; 🇫🇷 Montbrison, France

1245.33.3309A Boehringer Ingelheim Investigational Site; 🇫🇷 Nanterre Cedex, France

1245.33.3303A Boehringer Ingelheim Investigational Site; 🇫🇷 Saint Mandé, France

1245.33.3310A Boehringer Ingelheim Investigational Site; 🇫🇷 Nantes, France

1245.33.3304A Boehringer Ingelheim Investigational Site; 🇫🇷 Narbonne Cedex, France

1245.33.82008 Boehringer Ingelheim Investigational Site; 🇰🇷 Daejeon, Korea, Republic of

1245.33.82003 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1245.33.82007 Boehringer Ingelheim Investigational Site; 🇰🇷 Gwangju, Korea, Republic of

1245.33.82001 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1245.33.82004 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1245.33.82006 Boehringer Ingelheim Investigational Site; 🇰🇷 Wonju, Korea, Republic of

1245.33.82002 Boehringer Ingelheim Investigational Site; 🇰🇷 Yangsan, Korea, Republic of

1245.33.82005 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1245.33.35101 Boehringer Ingelheim Investigational Site; 🇵🇹 Coimbra, Portugal

1245.33.44001 Boehringer Ingelheim Investigational Site; 🇬🇧 Bath, United Kingdom

1245.33.44005 Boehringer Ingelheim Investigational Site; 🇬🇧 Dorking, United Kingdom

1245.33.44006 Boehringer Ingelheim Investigational Site; 🇬🇧 Blackburn, United Kingdom

1245.33.44009 Boehringer Ingelheim Investigational Site; 🇬🇧 Headington, United Kingdom

1245.33.44008 Boehringer Ingelheim Investigational Site; 🇬🇧 Leicester, United Kingdom

1245.33.44004 Boehringer Ingelheim Investigational Site; 🇬🇧 Liverpool, United Kingdom

1245.33.44002 Boehringer Ingelheim Investigational Site; 🇬🇧 Whitstable, United Kingdom

1245.33.44010 Boehringer Ingelheim Investigational Site; 🇬🇧 Wymondham, United Kingdom

1245.33.01022 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Louis, Maryland, United States

1245.33.35302 Boehringer Ingelheim Investigational Site; 🇮🇪 Dublin, Ireland

1245.33.35303 Boehringer Ingelheim Investigational Site; 🇮🇪 Dublin, Ireland

1245.33.35304 Boehringer Ingelheim Investigational Site; 🇮🇪 Dublin, Ireland

1245.33.35104 Boehringer Ingelheim Investigational Site; 🇵🇹 Aveiro, Portugal

1245.33.35102 Boehringer Ingelheim Investigational Site; 🇵🇹 Lisboa, Portugal

1245.33.35106 Boehringer Ingelheim Investigational Site; 🇵🇹 Lisboa, Portugal

1245.33.35107 Boehringer Ingelheim Investigational Site; 🇵🇹 Lisboa, Portugal

1245.33.01047 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1245.33.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1245.33.01027 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, 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

1245.33.01043 Boehringer Ingelheim Investigational Site; 🇺🇸 Las Vegas, Nevada, United States

1245.33.01025 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

1245.33.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

1245.33.01023 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

1245.33.01030 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

1245.33.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1245.33.01011 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1245.33.01049 Boehringer Ingelheim Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

1245.33.45004 Boehringer Ingelheim Investigational Site; 🇩🇰 Gentofte, Denmark

1245.33.01017 Boehringer Ingelheim Investigational Site; 🇺🇸 Omaha, Nebraska, United States

1245.33.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1245.33.01054 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

1245.33.01061 Boehringer Ingelheim Investigational Site; 🇺🇸 Milwaukee, Wisconsin, United States

1245.33.44003 Boehringer Ingelheim Investigational Site; 🇬🇧 Birmingham, United Kingdom

1245.33.44007 Boehringer Ingelheim Investigational Site; 🇬🇧 Wembley, United Kingdom

1245.33.01055 Boehringer Ingelheim Investigational Site; 🇺🇸 Paramount, California, United States

1245.33.01032 Boehringer Ingelheim Investigational Site; 🇺🇸 Kansas City, Missouri, United States

1245.33.01026 Boehringer Ingelheim Investigational Site; 🇺🇸 Winston-Salem, North Carolina, United States