Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: BI 1356 dose 1 once daily
Drug: BI 1356 dose 2 once daily
Drug: BI 1356 dose 3 once daily
Drug: Metformin

Registration Number: NCT00328172

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 302

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets matching BI 1356
BI 1356 0.5 mg	BI 1356 dose 1 once daily	BI 1356 dose 1 once daily
BI 1356 2.5 mg	BI 1356 dose 2 once daily	BI 1356 dose 2 once daily
BI 1356 5.0 mg	BI 1356 dose 3 once daily	BI 1356 dose 3 once daily
Metformin	Metformin	Metformin

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12	Baseline, week 12	The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12	Baseline, week 12	Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG.
Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks	Baseline, week 12	An absolute efficacy response is defined as HbA1c \<= 7.0% at 12 weeks. A non-response is defined as HbA1c \> 7.0% at 12 weeks.

Trial Locations

Locations (71): 1218.5.10026 Boehringer Ingelheim Investigational Site
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Columbus, Ohio, United States
1218.5.11002 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
1218.5.10016 Boehringer Ingelheim Investigational Site
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Jacksonville, Florida, United States
1218.5.10020 Boehringer Ingelheim Investigational Site
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Chula Vista, California, United States
1218.5.38002 Boehringer Ingelheim Investigational Site
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Kiev, Ukraine
1218.5.38001 Boehringer Ingelheim Investigational Site
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Kiev, Ukraine
1218.5.38006 Boehringer Ingelheim Investigational Site
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Vinnitsa, Ukraine
1218.5.10011 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
1218.5.10003 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
1218.5.10041 Boehringer Ingelheim Investigational Site
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Denver, Colorado, United States
1218.5.10017 Boehringer Ingelheim Investigational Site
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Indianapolis, Indiana, United States
1218.5.10009 Boehringer Ingelheim Investigational Site
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Omaha, Nebraska, United States
1218.5.10040 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
1218.5.10036 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
1218.5.61005 Boehringer Ingelheim Investigational Site
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Box Hill, Victoria, Australia
1218.5.10018 Boehringer Ingelheim Investigational Site
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Hollywood, Florida, United States
1218.5.10001 Boehringer Ingelheim Investigational Site
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La Jolla, California, United States
1218.5.10007 Boehringer Ingelheim Investigational Site
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Walnut Creek, California, United States
1218.5.10024 Boehringer Ingelheim Investigational Site
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Wichita, Kansas, United States
1218.5.10008 Boehringer Ingelheim Investigational Site
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Topeka, Kansas, United States
1218.5.10032 Boehringer Ingelheim Investigational Site
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Springfield, Massachusetts, United States
1218.5.10039 Boehringer Ingelheim Investigational Site
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Baltimore, Maryland, United States
1218.5.10025 Boehringer Ingelheim Investigational Site
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Chesterfield, Missouri, United States
1218.5.10029 Boehringer Ingelheim Investigational Site
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Endwell, New York, United States
1218.5.10004 Boehringer Ingelheim Investigational Site
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New Hyde Park, New York, United States
1218.5.10042 Boehringer Ingelheim Investigational Site
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Albany, New York, United States
1218.5.10035 Boehringer Ingelheim Investigational Site
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Mentor, Ohio, United States
1218.5.10023 Boehringer Ingelheim Investigational Site
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Medford, Oregon, United States
1218.5.10030 Boehringer Ingelheim Investigational Site
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Philadelphia, Pennsylvania, United States
1218.5.10044 Boehringer Ingelheim Investigational Site
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Columbia, South Carolina, United States
1218.5.10033 Boehringer Ingelheim Investigational Site
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Greer, South Carolina, United States
1218.5.10006 Boehringer Ingelheim Investigational Site
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Dallas, Texas, United States
1218.5.10038 Boehringer Ingelheim Investigational Site
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Simpsonville, South Carolina, United States
1218.5.10021 Boehringer Ingelheim Investigational Site
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Tyler, Texas, United States
1218.5.10027 Boehringer Ingelheim Investigational Site
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Salem, Virginia, United States
1218.5.10014 Boehringer Ingelheim Investigational Site
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Renton, Washington, United States
1218.5.10022 Boehringer Ingelheim Investigational Site
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Federal Way, Washington, United States
1218.5.61001 Boehringer Ingelheim Investigational Site
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Miranda, New South Wales, Australia
1218.5.61006 Boehringer Ingelheim Investigational Site
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Dandenong, Victoria, Australia
1218.5.61007 Boehringer Ingelheim Investigational Site
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East Ringwood, Victoria, Australia
1218.5.61004 Boehringer Ingelheim Investigational Site
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Fremantle, Western Australia, Australia
1218.5.61002 Boehringer Ingelheim Investigational Site
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Nedlands, Western Australia, Australia
1218.5.11011 Boehringer Ingelheim Investigational Site
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Calgary, Alberta, Canada
1218.5.11003 Boehringer Ingelheim Investigational Site
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Red Deer, Alberta, Canada
1218.5.11016 Boehringer Ingelheim Investigational Site
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Calgary, Alberta, Canada
1218.5.11004 Boehringer Ingelheim Investigational Site
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Vancouver, British Columbia, Canada
1218.5.11013 Boehringer Ingelheim Investigational Site
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Vancouver, British Columbia, Canada
1218.5.11005 Boehringer Ingelheim Investigational Site
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Hamilton, Ontario, Canada
1218.5.11015 Boehringer Ingelheim Investigational Site
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Winnipeg, Manitoba, Canada
1218.5.11014 Boehringer Ingelheim Investigational Site
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Oakville, Ontario, Canada
1218.5.11012 Boehringer Ingelheim Investigational Site
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Thornhill, Ontario, Canada
1218.5.11009 Boehringer Ingelheim Investigational Site
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Sarnia, Ontario, Canada
1218.5.11010 Boehringer Ingelheim Investigational Site
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Ottawa, Ontario, Canada
1218.5.11017 Boehringer Ingelheim Investigational Site
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Sainte-Foy, Quebec, Canada
1218.5.11018 Boehringer Ingelheim Investigational Site
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Saskatoon, Saskatchewan, Canada
1218.5.11006 Boehringer Ingelheim Investigational Site
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Montague, Prince Edward Island, Canada
1218.5.42002 Boehringer Ingelheim Investigational Site
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Olomouc 9, Czech Republic
1218.5.42003 Boehringer Ingelheim Investigational Site
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Praha 4, Czech Republic
1218.5.42001 Boehringer Ingelheim Investigational Site
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Sternberk, Czech Republic
1218.5.42004 Boehringer Ingelheim Investigational Site
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Praha 9, Czech Republic
1218.5.70001 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1218.5.70003 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1218.5.70002 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1218.5.70004 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
1218.5.38003 Boehringer Ingelheim Investigational Site
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Kiev, Ukraine
1218.5.70005 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
1218.5.38005 Boehringer Ingelheim Investigational Site
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Kharkov, Ukraine
1218.5.10034 Boehringer Ingelheim Investigational Site
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Butte, Montana, United States
1218.5.42005 Boehringer Ingelheim Investigational Site
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Praha 4, Czech Republic
1218.5.38004 Boehringer Ingelheim Investigational Site
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Lvov, Ukraine
1218.5.10012 Boehringer Ingelheim Investigational Site
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Orlando, Florida, United States