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

December 11, 2013 updated by: Boehringer Ingelheim

A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1560

Phase

  • Phase 3

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

  • Bulgaria
      • Sofia, Bulgaria
        • 1218.20.35201 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1218.20.35202 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1218.20.35203 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1218.20.35207 Boehringer Ingelheim Investigational Site
      • Stara Zagora, Bulgaria
        • 1218.20.35204 Boehringer Ingelheim Investigational Site
  • Denmark
      • Aalborg, Denmark
        • 1218.20.45006 Boehringer Ingelheim Investigational Site
      • Aarhus C, Denmark
        • 1218.20.45001 Boehringer Ingelheim Investigational Site
      • Aarhus C, Denmark
        • 1218.20.45011 Boehringer Ingelheim Investigational Site
      • Aarhus C, Denmark
        • 1218.20.45013 Boehringer Ingelheim Investigational Site
      • Hvidovre, Denmark
        • 1218.20.45002 Boehringer Ingelheim Investigational Site
      • København NV, Denmark
        • 1218.20.45003 Boehringer Ingelheim Investigational Site
      • Odense, Denmark
        • 1218.20.45007 Boehringer Ingelheim Investigational Site
  • France
      • Joué les Tours, France
        • 1218.20.3308A Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3308C Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3308D Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3308E Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3308F Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3309A Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3309B Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3309C Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3309D Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3309E Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3311A Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3311B Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3311C Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3313A Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3313B Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3313C Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3313D Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3314A Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3314B Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3314C Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3314D Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3314E Boehringer Ingelheim Investigational Site
      • Joué les Tours, France
        • 1218.20.3314F Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3307A Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3310A Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3310B Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3310C Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3310D Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3310E Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3312A Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3312B Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3312C Boehringer Ingelheim Investigational Site
      • Joué les Tours Cedex, France
        • 1218.20.3312D Boehringer Ingelheim Investigational Site
      • Joué les Tours cedex, France
        • 1218.20.3307B Boehringer Ingelheim Investigational Site
      • Joué les Tours cedex, France
        • 1218.20.3307C Boehringer Ingelheim Investigational Site
      • Joué les Tours cedex, France
        • 1218.20.3307D Boehringer Ingelheim Investigational Site
      • Joué les Tours cedex, France
        • 1218.20.3307E Boehringer Ingelheim Investigational Site
      • Joué les Tours cedex, France
        • 1218.20.3307F Boehringer Ingelheim Investigational Site
      • Joué les Tours cedex, France
        • 1218.20.3307G Boehringer Ingelheim Investigational Site
      • Joué les Tours cedex, France
        • 1218.20.3307H Boehringer Ingelheim Investigational Site
      • Joué les Tours cedex, France
        • 1218.20.3307I Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3302A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3302C Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3302D Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3302E Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3302G Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3302H Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3302I Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3303A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3303B Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3303C Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3303D Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3303E Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3303G Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3303H Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3303I Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3304A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3304B Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3304C Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3304D Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3304F Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3304H Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3305A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3305B Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3305H Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3306A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3306B Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3306D Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3306F Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3306G Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3306H Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.20.3306I Boehringer Ingelheim Investigational Site
      • Nantes Cedex 1, France
        • 1218.20.3301A Boehringer Ingelheim Investigational Site
      • Potigny, France
        • 1218.20.3311D Boehringer Ingelheim Investigational Site
  • Germany
      • Aschaffenburg, Germany
        • 1218.20.49004 Boehringer Ingelheim Investigational Site
      • Bad Mergentheim, Germany
        • 1218.20.49028 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1218.20.49022 Boehringer Ingelheim Investigational Site
      • Bosenheim, Germany
        • 1218.20.49024 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1218.20.49020 Boehringer Ingelheim Investigational Site
      • Flörsheim, Germany
        • 1218.20.49018 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Germany
        • 1218.20.49015 Boehringer Ingelheim Investigational Site
      • Großheirath, Germany
        • 1218.20.49006 Boehringer Ingelheim Investigational Site
      • Haag, Germany
        • 1218.20.49025 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1218.20.49016 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1218.20.49029 Boehringer Ingelheim Investigational Site
      • Hatten, Germany
        • 1218.20.49021 Boehringer Ingelheim Investigational Site
      • Kelkheim, Germany
        • 1218.20.49017 Boehringer Ingelheim Investigational Site
      • Köln, Germany
        • 1218.20.49012 Boehringer Ingelheim Investigational Site
      • Künzing, Germany
        • 1218.20.49005 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1218.20.49010 Boehringer Ingelheim Investigational Site
      • Neuwied, Germany
        • 1218.20.49003 Boehringer Ingelheim Investigational Site
      • Nürnberg, Germany
        • 1218.20.49007 Boehringer Ingelheim Investigational Site
      • Rednitzhembach, Germany
        • 1218.20.49008 Boehringer Ingelheim Investigational Site
      • Saaldorf-Surheim, Germany
        • 1218.20.49027 Boehringer Ingelheim Investigational Site
      • Saarbrücken, Germany
        • 1218.20.49014 Boehringer Ingelheim Investigational Site
      • Speyer, Germany
        • 1218.20.49030 Boehringer Ingelheim Investigational Site
      • St. Ingbert/Oberwürzbach, Germany
        • 1218.20.49019 Boehringer Ingelheim Investigational Site
      • Sulzbach-Rosenberg, Germany
        • 1218.20.49002 Boehringer Ingelheim Investigational Site
      • Unterschneidheim, Germany
        • 1218.20.49009 Boehringer Ingelheim Investigational Site
      • Wangen, Germany
        • 1218.20.49026 Boehringer Ingelheim Investigational Site
      • Westerkappeln, Germany
        • 1218.20.49011 Boehringer Ingelheim Investigational Site
      • Würzburg, Germany
        • 1218.20.49013 Boehringer Ingelheim Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • 1218.20.85201 Boehringer Ingelheim Investigational Site
      • Hong Kong, Hong Kong
        • 1218.20.85202 Boehringer Ingelheim Investigational Site
      • Hong Kong, Hong Kong
        • 1218.20.85204 Boehringer Ingelheim Investigational Site
  • Hungary
      • Ajka, Hungary
        • 1218.20.36208 Boehringer Ingelheim Investigational Site
      • Baja, Hungary
        • 1218.20.36205 Boehringer Ingelheim Investigational Site
      • Békéscsaba, Hungary
        • 1218.20.36204 Boehringer Ingelheim Investigational Site
      • Hódmezövásárhely, Hungary
        • 1218.20.36206 Boehringer Ingelheim Investigational Site
      • Makó, Hungary
        • 1218.20.36202 Boehringer Ingelheim Investigational Site
      • Miskolc, Hungary
        • 1218.20.36201 Boehringer Ingelheim Investigational Site
      • Mosonmagyarovar, Hungary
        • 1218.20.36207 Boehringer Ingelheim Investigational Site
      • Szentes, Hungary
        • 1218.20.36203 Boehringer Ingelheim Investigational Site
  • India
      • Chennai, India
        • 1218.20.91022 Boehringer Ingelheim Investigational Site
      • Coimbatore, India
        • 1218.20.91024 Boehringer Ingelheim Investigational Site
      • Gujarat, India
        • 1218.20.91025 Boehringer Ingelheim Investigational Site
      • Hyderabad, India
        • 1218.20.91023 Boehringer Ingelheim Investigational Site
      • Kochi, India
        • 1218.20.91021 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 1218.20.91020 Boehringer Ingelheim Investigational Site
      • Patna, India
        • 1218.20.91027 Boehringer Ingelheim Investigational Site
      • Tamilnadu, India
        • 1218.20.91026 Boehringer Ingelheim Investigational Site
  • Ireland
      • Co. Cork, Ireland
        • 1218.20.35307 Boehringer Ingelheim Investigational Site
      • Co. Wexford, Ireland
        • 1218.20.35304 Boehringer Ingelheim Investigational Site
      • Co. Wexford, Ireland
        • 1218.20.35306 Boehringer Ingelheim Investigational Site
      • Co. Wexford, Ireland
        • 1218.20.35310 Boehringer Ingelheim Investigational Site
      • Dublin, Ireland
        • 1218.20.35308 Boehringer Ingelheim Investigational Site
      • Waterford, Ireland
        • 1218.20.35303 Boehringer Ingelheim Investigational Site
  • Italy
      • Catania, Italy
        • 1218.20.39034 Boehringer Ingelheim Investigational Site
      • Chieti, Italy
        • 1218.20.39027 Boehringer Ingelheim Investigational Site
      • Codogno (lo), Italy
        • 1218.20.39029 Boehringer Ingelheim Investigational Site
      • Genova, Italy
        • 1218.20.39021 Boehringer Ingelheim Investigational Site
      • Perugia, Italy
        • 1218.20.39033 Boehringer Ingelheim Investigational Site
      • Pordenone, Italy
        • 1218.20.39022 Boehringer Ingelheim Investigational Site
      • Ravenna, Italy
        • 1218.20.39028 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1218.20.39030 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1218.20.39032 Boehringer Ingelheim Investigational Site
      • Siena, Italy
        • 1218.20.39020 Boehringer Ingelheim Investigational Site
  • Netherlands
      • 's Hertogenbosch, Netherlands
        • 1218.20.31023 Boehringer Ingelheim Investigational Site
      • Almere, Netherlands
        • 1218.20.31014 Boehringer Ingelheim Investigational Site
      • Beek en Donk, Netherlands
        • 1218.20.31016 Boehringer Ingelheim Investigational Site
      • Ewijk, Netherlands
        • 1218.20.31011 Boehringer Ingelheim Investigational Site
      • Hoogwoud, Netherlands
        • 1218.20.31018 Boehringer Ingelheim Investigational Site
      • Oude Pekela, Netherlands
        • 1218.20.31012 Boehringer Ingelheim Investigational Site
      • Rilland, Netherlands
        • 1218.20.31022 Boehringer Ingelheim Investigational Site
      • Roelofarendsveen, Netherlands
        • 1218.20.31019 Boehringer Ingelheim Investigational Site
      • Wildervank, Netherlands
        • 1218.20.31013 Boehringer Ingelheim Investigational Site
  • Norway
      • Fevik, Norway
        • 1218.20.47005 Boehringer Ingelheim Investigational Site
      • Fornebu, Norway
        • 1218.20.47004 Boehringer Ingelheim Investigational Site
      • Hamar, Norway
        • 1218.20.47002 Boehringer Ingelheim Investigational Site
      • RUD, Norway
        • 1218.20.47001 Boehringer Ingelheim Investigational Site
      • Sandvika, Norway
        • 1218.20.47003 Boehringer Ingelheim Investigational Site
  • Poland
      • Bialystok, Poland
        • 1218.20.48210 Boehringer Ingelheim Investigational Site
      • Gdynia, Poland
        • 1218.20.48208 Boehringer Ingelheim Investigational Site
      • Krakow, Poland
        • 1218.20.48207 Boehringer Ingelheim Investigational Site
      • Lodz, Poland
        • 1218.20.48201 Boehringer Ingelheim Investigational Site
      • Lodz, Poland
        • 1218.20.48202 Boehringer Ingelheim Investigational Site
      • Olsztyn, Poland
        • 1218.20.48203 Boehringer Ingelheim Investigational Site
      • Torun, Poland
        • 1218.20.48206 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1218.20.48205 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1218.20.48209 Boehringer Ingelheim Investigational Site
  • South Africa
      • Bellville, South Africa
        • 1218.20.27007 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 1218.20.27002 Boehringer Ingelheim Investigational Site
      • Durban, South Africa
        • 1218.20.27006 Boehringer Ingelheim Investigational Site
      • Lenasia, South Africa
        • 1218.20.27004 Boehringer Ingelheim Investigational Site
      • Lenasia, South Africa
        • 1218.20.27005 Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa
        • 1218.20.27003 Boehringer Ingelheim Investigational Site
  • Sweden
      • Göteborg, Sweden
        • 1218.20.46003 Boehringer Ingelheim Investigational Site
      • Malmö, Sweden
        • 1218.20.46001 Boehringer Ingelheim Investigational Site
      • Malmö, Sweden
        • 1218.20.46002 Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden
        • 1218.20.46004 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Baillieston, Glasgow, United Kingdom
        • 1218.20.44108 Boehringer Ingelheim Investigational Site
      • Blackpool, United Kingdom
        • 1218.20.44115 Boehringer Ingelheim Investigational Site
      • Bradford on Avon, United Kingdom
        • 1218.20.44110 Boehringer Ingelheim Investigational Site
      • Buckshaw Village, Chorley, United Kingdom
        • 1218.20.44102 Boehringer Ingelheim Investigational Site
      • Cheadle, United Kingdom
        • 1218.20.44114 Boehringer Ingelheim Investigational Site
      • Chestfield, Whitstable, United Kingdom
        • 1218.20.44116 Boehringer Ingelheim Investigational Site
      • Chippenham, United Kingdom
        • 1218.20.44109 Boehringer Ingelheim Investigational Site
      • Dundee, United Kingdom
        • 1218.20.44113 Boehringer Ingelheim Investigational Site
      • Edgbaston, Birmingham, United Kingdom
        • 1218.20.44105 Boehringer Ingelheim Investigational Site
      • Ely, United Kingdom
        • 1218.20.44112 Boehringer Ingelheim Investigational Site
      • Guildford, United Kingdom
        • 1218.20.44101 Boehringer Ingelheim Investigational Site
      • Manchester, United Kingdom
        • 1218.20.44103 Boehringer Ingelheim Investigational Site
      • Trowbridge, United Kingdom
        • 1218.20.44106 Boehringer Ingelheim Investigational Site
      • Waterloo, Liverpool, United Kingdom
        • 1218.20.44104 Boehringer Ingelheim Investigational Site
      • Westbury, United Kingdom
        • 1218.20.44111 Boehringer Ingelheim Investigational Site
      • Whitstable, United Kingdom
        • 1218.20.44107 Boehringer Ingelheim Investigational Site
  • United States
    • Arizona
      • Tempe, Arizona, United States
        • 1218.20.10033 Boehringer Ingelheim Investigational Site
    • California
      • Chula Vista, California, United States
        • 1218.20.10003 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1218.20.10020 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1218.20.10035 Boehringer Ingelheim Investigational Site
      • Los Gatos, California, United States
        • 1218.20.10037 Boehringer Ingelheim Investigational Site
    • Florida
      • West Palm Beach, Florida, United States
        • 1218.20.10034 Boehringer Ingelheim Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States
        • 1218.20.10023 Boehringer Ingelheim Investigational Site
    • Kansas
      • Topeka, Kansas, United States
        • 1218.20.10030 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 1218.20.10028 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 1218.20.10006 Boehringer Ingelheim Investigational Site
    • New York
      • Endwell, New York, United States
        • 1218.20.10022 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1218.20.10032 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 1218.20.10031 Boehringer Ingelheim Investigational Site
      • Mentor, Ohio, United States
        • 1218.20.10013 Boehringer Ingelheim Investigational Site
      • Perrysburg, Ohio, United States
        • 1218.20.10045 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 1218.20.10042 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1218.20.10024 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greer, South Carolina, United States
        • 1218.20.10002 Boehringer Ingelheim Investigational Site
    • Texas
      • San Antonio, Texas, United States
        • 1218.20.10007 Boehringer Ingelheim Investigational Site
    • Utah
      • Murray, Utah, United States
        • 1218.20.10036 Boehringer Ingelheim Investigational Site
      • Salt Lake City, Utah, United States
        • 1218.20.10029 Boehringer Ingelheim Investigational Site
    • Washington
      • Federal Way, Washington, United States
        • 1218.20.10009 Boehringer Ingelheim Investigational Site
      • Renton, Washington, United States
        • 1218.20.10026 Boehringer Ingelheim Investigational Site

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BI 1356 5mg, once daily
patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride
Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
Placebo tablets once daily
Drug: BI 1356
5mg, once daily in the morning for 104 weeks
ACTIVE_COMPARATOR: 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)
Drug: Placebo identical to BI 1356 5mg
Placebo tablet once daily
Drug: Glimepiride
1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline at Week 52
Time Frame: Baseline and week 52
This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Baseline and week 52
HbA1c Change From Baseline at Week 104
Time Frame: Baseline and week 104
This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Baseline and week 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight Change From Baseline at Week 52
Time Frame: Baseline and week 52
This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Baseline and week 52
Body Weight Change From Baseline at Week 104
Time Frame: Baseline and week 104
This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Baseline and week 104
Incidence of Hypoglycaemic Events up to 52 Weeks
Time Frame: Week 52
A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)
Week 52
Incidence of Hypoglycaemic Events up to 104 Weeks
Time Frame: Week 104
A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)
Week 104
Fasting Plasma Glucose (FPG) Change From Baseline at Week 52
Time Frame: Baseline and week 52
This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.
Baseline and week 52
Fasting Plasma Glucose (FPG) Change From Baseline at Week 104
Time Frame: Baseline and week 104
This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.
Baseline and week 104
Percentage of Patients With HbA1c <7.0% at Week 52
Time Frame: Week 52
The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Week 52
Percentage of Patients With HbA1c <7.0% at Week 104
Time Frame: Week 104
The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Week 104
Percentage of Patients With HbA1c <6.5% at Week 52
Time Frame: Week 52
The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Week 52
Percentage of Patients With HbA1c <6.5% at Week 104
Time Frame: Week 104
The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Week 104
Percentage of Patients With HbA1c Lowering by 0.5% at Week 104
Time Frame: Week 104
Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104
Week 104
2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104
Time Frame: Baseline and week 104
This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.
Baseline and week 104
HbA1c Change at Week 4
Time Frame: Baseline and week 4
Difference of base percent value [Week x(%) - baseline (%)]
Baseline and week 4
HbA1c Change at Week 8
Time Frame: Baseline and week 8
Baseline and week 8
HbA1c Change at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
HbA1c Change at Week 16
Time Frame: Baseline and week 16
Baseline and week 16
HbA1c Change at Week 28
Time Frame: Baseline and week 28
Baseline and week 28
HbA1c Change at Week 40
Time Frame: Baseline and week 40
Baseline and week 40
HbA1c Change at Week 52
Time Frame: Baseline and week 52
Baseline and week 52
HbA1c Change at Week 65
Time Frame: Baseline and week 65
Baseline and week 65
HbA1c Change at Week 78
Time Frame: Baseline and week 78
Baseline and week 78
HbA1c Change at Week 91
Time Frame: Baseline and week 91
Baseline and week 91
HbA1c Change at Week 104
Time Frame: Baseline and week 104
The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.
Baseline and week 104
Change in Baseline Lipid Parameter Cholesterol at Week 104
Time Frame: Baseline and week 104
Baseline and week 104
Change in Baseline Lipid Parameter HDL at Week 104
Time Frame: Baseline and week 104
Baseline and week 104
Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104
Time Frame: Baseline and week 104
Baseline and week 104
Change in Baseline Lipid Parameter Triglyceride at Week 104
Time Frame: Baseline and week 104
Baseline and week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

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.

General Publications

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

February 1, 2008

Primary Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (ESTIMATE)

February 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2014

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.20
  • 2007-004585-40 (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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