A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Linagliptin Placebo
Drug: Linagliptin
Drug: Glimepiride

Registration Number: NCT00740051

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 227

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Linagliptin Placebo	First 18 weeks of treatment
Linagliptin	Linagliptin	52 week treatment
Glimepiride	Glimepiride	Placebo patients switch to glimepiride week19-52

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline at Week 18 (Interim Analysis)	Baseline and week 18	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
HbA1c Change From Baseline at Week 18 (Final Analysis)	Baseline and week 18	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)	Baseline and week 18	This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).
Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)	Week 18	Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)	Week 18	Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)	Week 18	Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
The Change in HbA1c From Baseline by Visit Over Time	Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52	HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.
The Change in FPG From Baseline by Visit Over Time	Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52	This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.

Trial Locations

Locations (53): 1218.50.10011 Boehringer Ingelheim Investigational Site
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Peoria, Arizona, United States
1218.50.10002 Boehringer Ingelheim Investigational Site
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Eugene, Oregon, United States
1218.50.63007 Boehringer Ingelheim Investigational Site
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Pasay, Philippines
1218.50.10005 Boehringer Ingelheim Investigational Site
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Kingsport, Tennessee, United States
1218.50.52007 Boehringer Ingelheim Investigational Site
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Aguascalientes, Mexico
1218.50.11004 Boehringer Ingelheim Investigational Site
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Saskatoon, Saskatchewan, Canada
1218.50.52002 Boehringer Ingelheim Investigational Site
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Mexico, Mexico
1218.50.52003 Boehringer Ingelheim Investigational Site
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Monterrey, Mexico
1218.50.52005 Boehringer Ingelheim Investigational Site
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México, Mexico
1218.50.63001 Boehringer Ingelheim Investigational Site
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Marikina, Philippines
1218.50.63002 Boehringer Ingelheim Investigational Site
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Pasig, Philippines
1218.50.40001 Boehringer Ingelheim Investigational Site
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Bucharest, Romania
1218.50.40005 Boehringer Ingelheim Investigational Site
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Galati, Romania
1218.50.70001 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1218.50.38002 Boehringer Ingelheim Investigational Site
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Kharkiv, Ukraine
1218.50.10009 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
1218.50.10016 Boehringer Ingelheim Investigational Site
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Harbor City, California, United States
1218.50.10006 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
1218.50.10013 Boehringer Ingelheim Investigational Site
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Greenbrae, California, United States
1218.50.10017 Boehringer Ingelheim Investigational Site
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Huntington Park, California, United States
1218.50.10007 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
1218.50.10012 Boehringer Ingelheim Investigational Site
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Dallas, Texas, United States
1218.50.63006 Boehringer Ingelheim Investigational Site
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Manila, Philippines
1218.50.40002 Boehringer Ingelheim Investigational Site
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Bucharest, Romania
1218.50.10022 Boehringer Ingelheim Investigational Site
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Dallas, Texas, United States
1218.50.52008 Boehringer Ingelheim Investigational Site
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Mexico, Mexico
1218.50.11001 Boehringer Ingelheim Investigational Site
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Edmonton, Alberta, Canada
1218.50.11005 Boehringer Ingelheim Investigational Site
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Sarnia, Ontario, Canada
1218.50.10004 Boehringer Ingelheim Investigational Site
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Statesville, North Carolina, United States
1218.50.10015 Boehringer Ingelheim Investigational Site
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Greer, South Carolina, United States
1218.50.52010 Boehringer Ingelheim Investigational Site
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Guadalajara, Mexico
1218.50.52009 Boehringer Ingelheim Investigational Site
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León, Mexico
1218.50.52004 Boehringer Ingelheim Investigational Site
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México, Mexico
1218.50.63008 Boehringer Ingelheim Investigational Site
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Manila, Philippines
1218.50.70005 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
1218.50.38001 Boehringer Ingelheim Investigational Site
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Kiev, Ukraine
1218.50.11002 Boehringer Ingelheim Investigational Site
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Montague, Prince Edward Island, Canada
1218.50.52001 Boehringer Ingelheim Investigational Site
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Monterrey, Mexico
1218.50.63003 Boehringer Ingelheim Investigational Site
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Cebu, Philippines
1218.50.63005 Boehringer Ingelheim Investigational Site
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Cebu, Philippines
1218.50.63004 Boehringer Ingelheim Investigational Site
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Marikina, Philippines
1218.50.63009 Boehringer Ingelheim Investigational Site
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Pasig, Philippines
1218.50.40004 Boehringer Ingelheim Investigational Site
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Brasov, Romania
1218.50.40003 Boehringer Ingelheim Investigational Site
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Sibiu, Romania
1218.50.70002 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
1218.50.70003 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1218.50.70004 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
1218.50.38003 Boehringer Ingelheim Investigational Site
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Lvov, Ukraine
1218.50.38004 Boehringer Ingelheim Investigational Site
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Kiev, Ukraine
1218.50.38005 Boehringer Ingelheim Investigational Site
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Vinnitsa, Ukraine
1218.50.10010 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
1218.50.10018 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
1218.50.11003 Boehringer Ingelheim Investigational Site
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Edmonton, Alberta, Canada