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Efficacy and Safety of BI 135...

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

Last Updated: 2014-01-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 1356 5mg, once daily

patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride

Group Type EXPERIMENTAL

Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg

Intervention Type DRUG

Placebo tablets once daily

BI 1356

Intervention Type DRUG

5mg, once daily in the morning for 104 weeks

Glimepiride

patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)

Group Type ACTIVE_COMPARATOR

Placebo identical to BI 1356 5mg

Intervention Type DRUG

Placebo tablet once daily

Glimepiride

Intervention Type DRUG

1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

Interventions

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Placebo identical to BI 1356 5mg

Placebo tablet once daily

Intervention Type DRUG

Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg

Placebo tablets once daily

Intervention Type DRUG

BI 1356

5mg, once daily in the morning for 104 weeks

Intervention Type DRUG

Glimepiride

1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Exclusion Criteria

1. Myocardial infarction, stroke or transient ischemic attack (TIA)
2. Impaired hepatic function
3. Renal failure or renal impairment
4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.20.10033 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Site Status

1218.20.10003 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Site Status

1218.20.10020 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1218.20.10035 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1218.20.10037 Boehringer Ingelheim Investigational Site

Los Gatos, California, United States

Site Status

1218.20.10034 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Site Status

1218.20.10023 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

1218.20.10030 Boehringer Ingelheim Investigational Site

Topeka, Kansas, United States

Site Status

1218.20.10028 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1218.20.10006 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Site Status

1218.20.10022 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Site Status

1218.20.10032 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1218.20.10031 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

1218.20.10013 Boehringer Ingelheim Investigational Site

Mentor, Ohio, United States

Site Status

1218.20.10045 Boehringer Ingelheim Investigational Site

Perrysburg, Ohio, United States

Site Status

1218.20.10042 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

1218.20.10024 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1218.20.10002 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Site Status

1218.20.10007 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1218.20.10036 Boehringer Ingelheim Investigational Site

Murray, Utah, United States

Site Status

1218.20.10029 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Site Status

1218.20.10009 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Site Status

1218.20.10026 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Site Status

1218.20.35201 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1218.20.35202 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1218.20.35203 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1218.20.35207 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1218.20.35204 Boehringer Ingelheim Investigational Site

Stara Zagora, , Bulgaria

Site Status

1218.20.45006 Boehringer Ingelheim Investigational Site

Aalborg, , Denmark

Site Status

1218.20.45001 Boehringer Ingelheim Investigational Site

Aarhus C, , Denmark

Site Status

1218.20.45011 Boehringer Ingelheim Investigational Site

Aarhus C, , Denmark

Site Status

1218.20.45013 Boehringer Ingelheim Investigational Site

Aarhus C, , Denmark

Site Status

1218.20.45002 Boehringer Ingelheim Investigational Site

Hvidovre, , Denmark

Site Status

1218.20.45003 Boehringer Ingelheim Investigational Site

København NV, , Denmark

Site Status