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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00622284
First received: February 13, 2008
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo identical to BI 1356 5mg
Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
Drug: BI 1356
Drug: Glimepiride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • HbA1c Change From Baseline at Week 52 [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
    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.

  • HbA1c Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Body Weight Change From Baseline at Week 52 [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
    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.

  • Body Weight Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.

  • Incidence of Hypoglycaemic Events up to 52 Weeks [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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)

  • Incidence of Hypoglycaemic Events up to 104 Weeks [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    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)

  • Fasting Plasma Glucose (FPG) Change From Baseline at Week 52 [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
    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.

  • Fasting Plasma Glucose (FPG) Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With HbA1c <7.0% at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With HbA1c <7.0% at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With HbA1c <6.5% at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With HbA1c <6.5% at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With HbA1c Lowering by 0.5% at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104

  • 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.

  • HbA1c Change at Week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
    Difference of base percent value [Week x(%) - baseline (%)]

  • HbA1c Change at Week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 16 [ Time Frame: Baseline and week 16 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 28 [ Time Frame: Baseline and week 28 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 40 [ Time Frame: Baseline and week 40 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 52 [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 65 [ Time Frame: Baseline and week 65 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 78 [ Time Frame: Baseline and week 78 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 91 [ Time Frame: Baseline and week 91 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.

  • Change in Baseline Lipid Parameter Cholesterol at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
  • Change in Baseline Lipid Parameter HDL at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
  • Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
  • Change in Baseline Lipid Parameter Triglyceride at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]

Enrollment: 1560
Study Start Date: February 2008
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622284

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

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00622284     History of Changes
Other Study ID Numbers: 1218.20, 2007-004585-40
Study First Received: February 13, 2008
Results First Received: November 30, 2011
Last Updated: December 11, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Denmark: Danish Medicines Agency
France: AFSSAPS 143/147, bld Anatole France 93285 Saint-Denis Cedex FRANCE
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Italy: Comitato Etico Locale per la Sperimentazione Clinica dei Medicinali A.O. Universitaria Senese - Località Le Scotte - SIENA
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Poland: Registration Medicinal Product Medical Device Biocidal Product
South Africa: Medicines Control Council
Sweden: Sweden; Läkemedelsverket (Medical Product Agency)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
BI 1356
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014