search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo identical to BI 1356 5mg
Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
BI 1356
Glimepiride
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1218.20.10033 Boehringer Ingelheim Investigational Site
  • 1218.20.10003 Boehringer Ingelheim Investigational Site
  • 1218.20.10020 Boehringer Ingelheim Investigational Site
  • 1218.20.10035 Boehringer Ingelheim Investigational Site
  • 1218.20.10037 Boehringer Ingelheim Investigational Site
  • 1218.20.10034 Boehringer Ingelheim Investigational Site
  • 1218.20.10023 Boehringer Ingelheim Investigational Site
  • 1218.20.10030 Boehringer Ingelheim Investigational Site
  • 1218.20.10028 Boehringer Ingelheim Investigational Site
  • 1218.20.10006 Boehringer Ingelheim Investigational Site
  • 1218.20.10022 Boehringer Ingelheim Investigational Site
  • 1218.20.10032 Boehringer Ingelheim Investigational Site
  • 1218.20.10031 Boehringer Ingelheim Investigational Site
  • 1218.20.10013 Boehringer Ingelheim Investigational Site
  • 1218.20.10045 Boehringer Ingelheim Investigational Site
  • 1218.20.10042 Boehringer Ingelheim Investigational Site
  • 1218.20.10024 Boehringer Ingelheim Investigational Site
  • 1218.20.10002 Boehringer Ingelheim Investigational Site
  • 1218.20.10007 Boehringer Ingelheim Investigational Site
  • 1218.20.10036 Boehringer Ingelheim Investigational Site
  • 1218.20.10029 Boehringer Ingelheim Investigational Site
  • 1218.20.10009 Boehringer Ingelheim Investigational Site
  • 1218.20.10026 Boehringer Ingelheim Investigational Site
  • 1218.20.35201 Boehringer Ingelheim Investigational Site
  • 1218.20.35202 Boehringer Ingelheim Investigational Site
  • 1218.20.35203 Boehringer Ingelheim Investigational Site
  • 1218.20.35207 Boehringer Ingelheim Investigational Site
  • 1218.20.35204 Boehringer Ingelheim Investigational Site
  • 1218.20.45006 Boehringer Ingelheim Investigational Site
  • 1218.20.45001 Boehringer Ingelheim Investigational Site
  • 1218.20.45011 Boehringer Ingelheim Investigational Site
  • 1218.20.45013 Boehringer Ingelheim Investigational Site
  • 1218.20.45002 Boehringer Ingelheim Investigational Site
  • 1218.20.45003 Boehringer Ingelheim Investigational Site
  • 1218.20.45007 Boehringer Ingelheim Investigational Site
  • 1218.20.3307A Boehringer Ingelheim Investigational Site
  • 1218.20.3307B Boehringer Ingelheim Investigational Site
  • 1218.20.3307C Boehringer Ingelheim Investigational Site
  • 1218.20.3307D Boehringer Ingelheim Investigational Site
  • 1218.20.3307E Boehringer Ingelheim Investigational Site
  • 1218.20.3307F Boehringer Ingelheim Investigational Site
  • 1218.20.3307G Boehringer Ingelheim Investigational Site
  • 1218.20.3307H Boehringer Ingelheim Investigational Site
  • 1218.20.3307I Boehringer Ingelheim Investigational Site
  • 1218.20.3310A Boehringer Ingelheim Investigational Site
  • 1218.20.3310B Boehringer Ingelheim Investigational Site
  • 1218.20.3310C Boehringer Ingelheim Investigational Site
  • 1218.20.3310D Boehringer Ingelheim Investigational Site
  • 1218.20.3310E Boehringer Ingelheim Investigational Site
  • 1218.20.3312A Boehringer Ingelheim Investigational Site
  • 1218.20.3312B Boehringer Ingelheim Investigational Site
  • 1218.20.3312C Boehringer Ingelheim Investigational Site
  • 1218.20.3312D Boehringer Ingelheim Investigational Site
  • 1218.20.3308A Boehringer Ingelheim Investigational Site
  • 1218.20.3308C Boehringer Ingelheim Investigational Site
  • 1218.20.3308D Boehringer Ingelheim Investigational Site
  • 1218.20.3308E Boehringer Ingelheim Investigational Site
  • 1218.20.3308F Boehringer Ingelheim Investigational Site
  • 1218.20.3309A Boehringer Ingelheim Investigational Site
  • 1218.20.3309B Boehringer Ingelheim Investigational Site
  • 1218.20.3309C Boehringer Ingelheim Investigational Site
  • 1218.20.3309D Boehringer Ingelheim Investigational Site
  • 1218.20.3309E Boehringer Ingelheim Investigational Site
  • 1218.20.3311A Boehringer Ingelheim Investigational Site
  • 1218.20.3311B Boehringer Ingelheim Investigational Site
  • 1218.20.3311C Boehringer Ingelheim Investigational Site
  • 1218.20.3313A Boehringer Ingelheim Investigational Site
  • 1218.20.3313B Boehringer Ingelheim Investigational Site
  • 1218.20.3313C Boehringer Ingelheim Investigational Site
  • 1218.20.3313D Boehringer Ingelheim Investigational Site
  • 1218.20.3314A Boehringer Ingelheim Investigational Site
  • 1218.20.3314B Boehringer Ingelheim Investigational Site
  • 1218.20.3314C Boehringer Ingelheim Investigational Site
  • 1218.20.3314D Boehringer Ingelheim Investigational Site
  • 1218.20.3314E Boehringer Ingelheim Investigational Site
  • 1218.20.3314F Boehringer Ingelheim Investigational Site
  • 1218.20.3301A Boehringer Ingelheim Investigational Site
  • 1218.20.3302A Boehringer Ingelheim Investigational Site
  • 1218.20.3302C Boehringer Ingelheim Investigational Site
  • 1218.20.3302D Boehringer Ingelheim Investigational Site
  • 1218.20.3302E Boehringer Ingelheim Investigational Site
  • 1218.20.3302G Boehringer Ingelheim Investigational Site
  • 1218.20.3302H Boehringer Ingelheim Investigational Site
  • 1218.20.3302I Boehringer Ingelheim Investigational Site
  • 1218.20.3303A Boehringer Ingelheim Investigational Site
  • 1218.20.3303B Boehringer Ingelheim Investigational Site
  • 1218.20.3303C Boehringer Ingelheim Investigational Site
  • 1218.20.3303D Boehringer Ingelheim Investigational Site
  • 1218.20.3303E Boehringer Ingelheim Investigational Site
  • 1218.20.3303G Boehringer Ingelheim Investigational Site
  • 1218.20.3303H Boehringer Ingelheim Investigational Site
  • 1218.20.3303I Boehringer Ingelheim Investigational Site
  • 1218.20.3304A Boehringer Ingelheim Investigational Site
  • 1218.20.3304B Boehringer Ingelheim Investigational Site
  • 1218.20.3304C Boehringer Ingelheim Investigational Site
  • 1218.20.3304D Boehringer Ingelheim Investigational Site
  • 1218.20.3304F Boehringer Ingelheim Investigational Site
  • 1218.20.3304H Boehringer Ingelheim Investigational Site
  • 1218.20.3305A Boehringer Ingelheim Investigational Site
  • 1218.20.3305B Boehringer Ingelheim Investigational Site
  • 1218.20.3305H Boehringer Ingelheim Investigational Site
  • 1218.20.3306A Boehringer Ingelheim Investigational Site
  • 1218.20.3306B Boehringer Ingelheim Investigational Site
  • 1218.20.3306D Boehringer Ingelheim Investigational Site
  • 1218.20.3306F Boehringer Ingelheim Investigational Site
  • 1218.20.3306G Boehringer Ingelheim Investigational Site
  • 1218.20.3306H Boehringer Ingelheim Investigational Site
  • 1218.20.3306I Boehringer Ingelheim Investigational Site
  • 1218.20.3311D Boehringer Ingelheim Investigational Site
  • 1218.20.49004 Boehringer Ingelheim Investigational Site
  • 1218.20.49028 Boehringer Ingelheim Investigational Site
  • 1218.20.49022 Boehringer Ingelheim Investigational Site
  • 1218.20.49024 Boehringer Ingelheim Investigational Site
  • 1218.20.49020 Boehringer Ingelheim Investigational Site
  • 1218.20.49018 Boehringer Ingelheim Investigational Site
  • 1218.20.49015 Boehringer Ingelheim Investigational Site
  • 1218.20.49006 Boehringer Ingelheim Investigational Site
  • 1218.20.49025 Boehringer Ingelheim Investigational Site
  • 1218.20.49016 Boehringer Ingelheim Investigational Site
  • 1218.20.49029 Boehringer Ingelheim Investigational Site
  • 1218.20.49021 Boehringer Ingelheim Investigational Site
  • 1218.20.49017 Boehringer Ingelheim Investigational Site
  • 1218.20.49012 Boehringer Ingelheim Investigational Site
  • 1218.20.49005 Boehringer Ingelheim Investigational Site
  • 1218.20.49010 Boehringer Ingelheim Investigational Site
  • 1218.20.49003 Boehringer Ingelheim Investigational Site
  • 1218.20.49007 Boehringer Ingelheim Investigational Site
  • 1218.20.49008 Boehringer Ingelheim Investigational Site
  • 1218.20.49027 Boehringer Ingelheim Investigational Site
  • 1218.20.49014 Boehringer Ingelheim Investigational Site
  • 1218.20.49030 Boehringer Ingelheim Investigational Site
  • 1218.20.49019 Boehringer Ingelheim Investigational Site
  • 1218.20.49002 Boehringer Ingelheim Investigational Site
  • 1218.20.49009 Boehringer Ingelheim Investigational Site
  • 1218.20.49026 Boehringer Ingelheim Investigational Site
  • 1218.20.49011 Boehringer Ingelheim Investigational Site
  • 1218.20.49013 Boehringer Ingelheim Investigational Site
  • 1218.20.85201 Boehringer Ingelheim Investigational Site
  • 1218.20.85202 Boehringer Ingelheim Investigational Site
  • 1218.20.85204 Boehringer Ingelheim Investigational Site
  • 1218.20.36208 Boehringer Ingelheim Investigational Site
  • 1218.20.36205 Boehringer Ingelheim Investigational Site
  • 1218.20.36204 Boehringer Ingelheim Investigational Site
  • 1218.20.36206 Boehringer Ingelheim Investigational Site
  • 1218.20.36202 Boehringer Ingelheim Investigational Site
  • 1218.20.36201 Boehringer Ingelheim Investigational Site
  • 1218.20.36207 Boehringer Ingelheim Investigational Site
  • 1218.20.36203 Boehringer Ingelheim Investigational Site
  • 1218.20.91022 Boehringer Ingelheim Investigational Site
  • 1218.20.91024 Boehringer Ingelheim Investigational Site
  • 1218.20.91025 Boehringer Ingelheim Investigational Site
  • 1218.20.91023 Boehringer Ingelheim Investigational Site
  • 1218.20.91021 Boehringer Ingelheim Investigational Site
  • 1218.20.91020 Boehringer Ingelheim Investigational Site
  • 1218.20.91027 Boehringer Ingelheim Investigational Site
  • 1218.20.91026 Boehringer Ingelheim Investigational Site
  • 1218.20.35307 Boehringer Ingelheim Investigational Site
  • 1218.20.35304 Boehringer Ingelheim Investigational Site
  • 1218.20.35306 Boehringer Ingelheim Investigational Site
  • 1218.20.35310 Boehringer Ingelheim Investigational Site
  • 1218.20.35308 Boehringer Ingelheim Investigational Site
  • 1218.20.35303 Boehringer Ingelheim Investigational Site
  • 1218.20.39034 Boehringer Ingelheim Investigational Site
  • 1218.20.39027 Boehringer Ingelheim Investigational Site
  • 1218.20.39029 Boehringer Ingelheim Investigational Site
  • 1218.20.39021 Boehringer Ingelheim Investigational Site
  • 1218.20.39033 Boehringer Ingelheim Investigational Site
  • 1218.20.39022 Boehringer Ingelheim Investigational Site
  • 1218.20.39028 Boehringer Ingelheim Investigational Site
  • 1218.20.39030 Boehringer Ingelheim Investigational Site
  • 1218.20.39032 Boehringer Ingelheim Investigational Site
  • 1218.20.39020 Boehringer Ingelheim Investigational Site
  • 1218.20.31023 Boehringer Ingelheim Investigational Site
  • 1218.20.31014 Boehringer Ingelheim Investigational Site
  • 1218.20.31016 Boehringer Ingelheim Investigational Site
  • 1218.20.31011 Boehringer Ingelheim Investigational Site
  • 1218.20.31018 Boehringer Ingelheim Investigational Site
  • 1218.20.31012 Boehringer Ingelheim Investigational Site
  • 1218.20.31022 Boehringer Ingelheim Investigational Site
  • 1218.20.31019 Boehringer Ingelheim Investigational Site
  • 1218.20.31013 Boehringer Ingelheim Investigational Site
  • 1218.20.47005 Boehringer Ingelheim Investigational Site
  • 1218.20.47004 Boehringer Ingelheim Investigational Site
  • 1218.20.47002 Boehringer Ingelheim Investigational Site
  • 1218.20.47001 Boehringer Ingelheim Investigational Site
  • 1218.20.47003 Boehringer Ingelheim Investigational Site
  • 1218.20.48210 Boehringer Ingelheim Investigational Site
  • 1218.20.48208 Boehringer Ingelheim Investigational Site
  • 1218.20.48207 Boehringer Ingelheim Investigational Site
  • 1218.20.48201 Boehringer Ingelheim Investigational Site
  • 1218.20.48202 Boehringer Ingelheim Investigational Site
  • 1218.20.48203 Boehringer Ingelheim Investigational Site
  • 1218.20.48206 Boehringer Ingelheim Investigational Site
  • 1218.20.48205 Boehringer Ingelheim Investigational Site
  • 1218.20.48209 Boehringer Ingelheim Investigational Site
  • 1218.20.27007 Boehringer Ingelheim Investigational Site
  • 1218.20.27002 Boehringer Ingelheim Investigational Site
  • 1218.20.27006 Boehringer Ingelheim Investigational Site
  • 1218.20.27004 Boehringer Ingelheim Investigational Site
  • 1218.20.27005 Boehringer Ingelheim Investigational Site
  • 1218.20.27003 Boehringer Ingelheim Investigational Site
  • 1218.20.46003 Boehringer Ingelheim Investigational Site
  • 1218.20.46001 Boehringer Ingelheim Investigational Site
  • 1218.20.46002 Boehringer Ingelheim Investigational Site
  • 1218.20.46004 Boehringer Ingelheim Investigational Site
  • 1218.20.44108 Boehringer Ingelheim Investigational Site
  • 1218.20.44115 Boehringer Ingelheim Investigational Site
  • 1218.20.44110 Boehringer Ingelheim Investigational Site
  • 1218.20.44102 Boehringer Ingelheim Investigational Site
  • 1218.20.44114 Boehringer Ingelheim Investigational Site
  • 1218.20.44116 Boehringer Ingelheim Investigational Site
  • 1218.20.44109 Boehringer Ingelheim Investigational Site
  • 1218.20.44113 Boehringer Ingelheim Investigational Site
  • 1218.20.44105 Boehringer Ingelheim Investigational Site
  • 1218.20.44112 Boehringer Ingelheim Investigational Site
  • 1218.20.44101 Boehringer Ingelheim Investigational Site
  • 1218.20.44103 Boehringer Ingelheim Investigational Site
  • 1218.20.44106 Boehringer Ingelheim Investigational Site
  • 1218.20.44104 Boehringer Ingelheim Investigational Site
  • 1218.20.44111 Boehringer Ingelheim Investigational Site
  • 1218.20.44107 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BI 1356 5mg, once daily

Glimepiride

Arm Description

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

Outcomes

Primary Outcome Measures

HbA1c Change From Baseline at 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.
HbA1c Change From Baseline at 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.

Secondary Outcome Measures

Body Weight Change From Baseline at 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.
Body Weight Change From Baseline at 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.
Incidence of Hypoglycaemic Events up to 52 Weeks
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
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
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
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
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
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
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
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
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
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
Difference of base percent value [Week x(%) - baseline (%)]
HbA1c Change at Week 8
HbA1c Change at Week 12
HbA1c Change at Week 16
HbA1c Change at Week 28
HbA1c Change at Week 40
HbA1c Change at Week 52
HbA1c Change at Week 65
HbA1c Change at Week 78
HbA1c Change at Week 91
HbA1c Change at 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.
Change in Baseline Lipid Parameter Cholesterol at Week 104
Change in Baseline Lipid Parameter HDL at Week 104
Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104
Change in Baseline Lipid Parameter Triglyceride at Week 104

Full Information

First Posted
February 13, 2008
Last Updated
December 11, 2013
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00622284
Brief Title
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 1356 5mg, once daily
Arm Type
Experimental
Arm Description
patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo identical to BI 1356 5mg
Intervention Description
Placebo tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
Intervention Description
Placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
BI 1356
Intervention Description
5mg, once daily in the morning for 104 weeks
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Intervention Description
1mg or 2mg or 3mg or 4mg in the morning for 104 weeks
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline at Week 52
Description
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.
Time Frame
Baseline and week 52
Title
HbA1c Change From Baseline at Week 104
Description
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.
Time Frame
Baseline and week 104
Secondary Outcome Measure Information:
Title
Body Weight Change From Baseline at Week 52
Description
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.
Time Frame
Baseline and week 52
Title
Body Weight Change From Baseline at Week 104
Description
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.
Time Frame
Baseline and week 104
Title
Incidence of Hypoglycaemic Events up to 52 Weeks
Description
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)
Time Frame
Week 52
Title
Incidence of Hypoglycaemic Events up to 104 Weeks
Description
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)
Time Frame
Week 104
Title
Fasting Plasma Glucose (FPG) Change From Baseline at Week 52
Description
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.
Time Frame
Baseline and week 52
Title
Fasting Plasma Glucose (FPG) Change From Baseline at Week 104
Description
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.
Time Frame
Baseline and week 104
Title
Percentage of Patients With HbA1c <7.0% at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Patients With HbA1c <7.0% at Week 104
Description
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.
Time Frame
Week 104
Title
Percentage of Patients With HbA1c <6.5% at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Patients With HbA1c <6.5% at Week 104
Description
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.
Time Frame
Week 104
Title
Percentage of Patients With HbA1c Lowering by 0.5% at Week 104
Description
Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104
Time Frame
Week 104
Title
2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104
Description
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.
Time Frame
Baseline and week 104
Title
HbA1c Change at Week 4
Description
Difference of base percent value [Week x(%) - baseline (%)]
Time Frame
Baseline and week 4
Title
HbA1c Change at Week 8
Time Frame
Baseline and week 8
Title
HbA1c Change at Week 12
Time Frame
Baseline and week 12
Title
HbA1c Change at Week 16
Time Frame
Baseline and week 16
Title
HbA1c Change at Week 28
Time Frame
Baseline and week 28
Title
HbA1c Change at Week 40
Time Frame
Baseline and week 40
Title
HbA1c Change at Week 52
Time Frame
Baseline and week 52
Title
HbA1c Change at Week 65
Time Frame
Baseline and week 65
Title
HbA1c Change at Week 78
Time Frame
Baseline and week 78
Title
HbA1c Change at Week 91
Time Frame
Baseline and week 91
Title
HbA1c Change at Week 104
Description
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.
Time Frame
Baseline and week 104
Title
Change in Baseline Lipid Parameter Cholesterol at Week 104
Time Frame
Baseline and week 104
Title
Change in Baseline Lipid Parameter HDL at Week 104
Time Frame
Baseline and week 104
Title
Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104
Time Frame
Baseline and week 104
Title
Change in Baseline Lipid Parameter Triglyceride at Week 104
Time Frame
Baseline and week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase Exclusion criteria: Myocardial infarction, stroke or transient ischemic attack (TIA) Impaired hepatic function Renal failure or renal impairment Treatment with rosiglitazone or pioglitazone within 6 months prior to screening Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1218.20.10033 Boehringer Ingelheim Investigational Site
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
1218.20.10003 Boehringer Ingelheim Investigational Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
1218.20.10020 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1218.20.10035 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1218.20.10037 Boehringer Ingelheim Investigational Site
City
Los Gatos
State/Province
California
Country
United States
Facility Name
1218.20.10034 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
1218.20.10023 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
1218.20.10030 Boehringer Ingelheim Investigational Site
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
1218.20.10028 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1218.20.10006 Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
1218.20.10022 Boehringer Ingelheim Investigational Site
City
Endwell
State/Province
New York
Country
United States
Facility Name
1218.20.10032 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1218.20.10031 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
1218.20.10013 Boehringer Ingelheim Investigational Site
City
Mentor
State/Province
Ohio
Country
United States
Facility Name
1218.20.10045 Boehringer Ingelheim Investigational Site
City
Perrysburg
State/Province
Ohio
Country
United States
Facility Name
1218.20.10042 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
1218.20.10024 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1218.20.10002 Boehringer Ingelheim Investigational Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
1218.20.10007 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1218.20.10036 Boehringer Ingelheim Investigational Site
City
Murray
State/Province
Utah
Country
United States
Facility Name
1218.20.10029 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
1218.20.10009 Boehringer Ingelheim Investigational Site
City
Federal Way
State/Province
Washington
Country
United States
Facility Name
1218.20.10026 Boehringer Ingelheim Investigational Site
City
Renton
State/Province
Washington
Country
United States
Facility Name
1218.20.35201 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1218.20.35202 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1218.20.35203 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1218.20.35207 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1218.20.35204 Boehringer Ingelheim Investigational Site
City
Stara Zagora
Country
Bulgaria
Facility Name
1218.20.45006 Boehringer Ingelheim Investigational Site
City
Aalborg
Country
Denmark
Facility Name
1218.20.45001 Boehringer Ingelheim Investigational Site
City
Aarhus C
Country
Denmark
Facility Name
1218.20.45011 Boehringer Ingelheim Investigational Site
City
Aarhus C
Country
Denmark
Facility Name
1218.20.45013 Boehringer Ingelheim Investigational Site
City
Aarhus C
Country
Denmark
Facility Name
1218.20.45002 Boehringer Ingelheim Investigational Site
City
Hvidovre
Country
Denmark
Facility Name
1218.20.45003 Boehringer Ingelheim Investigational Site
City
København NV
Country
Denmark
Facility Name
1218.20.45007 Boehringer Ingelheim Investigational Site
City
Odense
Country
Denmark
Facility Name
1218.20.3307A Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3307B Boehringer Ingelheim Investigational Site
City
Joué les Tours cedex
Country
France
Facility Name
1218.20.3307C Boehringer Ingelheim Investigational Site
City
Joué les Tours cedex
Country
France
Facility Name
1218.20.3307D Boehringer Ingelheim Investigational Site
City
Joué les Tours cedex
Country
France
Facility Name
1218.20.3307E Boehringer Ingelheim Investigational Site
City
Joué les Tours cedex
Country
France
Facility Name
1218.20.3307F Boehringer Ingelheim Investigational Site
City
Joué les Tours cedex
Country
France
Facility Name
1218.20.3307G Boehringer Ingelheim Investigational Site
City
Joué les Tours cedex
Country
France
Facility Name
1218.20.3307H Boehringer Ingelheim Investigational Site
City
Joué les Tours cedex
Country
France
Facility Name
1218.20.3307I Boehringer Ingelheim Investigational Site
City
Joué les Tours cedex
Country
France
Facility Name
1218.20.3310A Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3310B Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3310C Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3310D Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3310E Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3312A Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3312B Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3312C Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3312D Boehringer Ingelheim Investigational Site
City
Joué les Tours Cedex
Country
France
Facility Name
1218.20.3308A Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3308C Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3308D Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3308E Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3308F Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3309A Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3309B Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3309C Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3309D Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3309E Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3311A Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3311B Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3311C Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3313A Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3313B Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3313C Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3313D Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3314A Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3314B Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3314C Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3314D Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3314E Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3314F Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.20.3301A Boehringer Ingelheim Investigational Site
City
Nantes Cedex 1
Country
France
Facility Name
1218.20.3302A Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3302C Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3302D Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3302E Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3302G Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3302H Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3302I Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3303A Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3303B Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3303C Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3303D Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3303E Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3303G Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3303H Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3303I Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3304A Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3304B Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3304C Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3304D Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3304F Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3304H Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3305A Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3305B Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3305H Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3306A Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3306B Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3306D Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3306F Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3306G Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3306H Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3306I Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1218.20.3311D Boehringer Ingelheim Investigational Site
City
Potigny
Country
France
Facility Name
1218.20.49004 Boehringer Ingelheim Investigational Site
City
Aschaffenburg
Country
Germany
Facility Name
1218.20.49028 Boehringer Ingelheim Investigational Site
City
Bad Mergentheim
Country
Germany
Facility Name
1218.20.49022 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1218.20.49024 Boehringer Ingelheim Investigational Site
City
Bosenheim
Country
Germany
Facility Name
1218.20.49020 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1218.20.49018 Boehringer Ingelheim Investigational Site
City
Flörsheim
Country
Germany
Facility Name
1218.20.49015 Boehringer Ingelheim Investigational Site
City
Frankfurt/Main
Country
Germany
Facility Name
1218.20.49006 Boehringer Ingelheim Investigational Site
City
Großheirath
Country
Germany
Facility Name
1218.20.49025 Boehringer Ingelheim Investigational Site
City
Haag
Country
Germany
Facility Name
1218.20.49016 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1218.20.49029 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1218.20.49021 Boehringer Ingelheim Investigational Site
City
Hatten
Country
Germany
Facility Name
1218.20.49017 Boehringer Ingelheim Investigational Site
City
Kelkheim
Country
Germany
Facility Name
1218.20.49012 Boehringer Ingelheim Investigational Site
City
Köln
Country
Germany
Facility Name
1218.20.49005 Boehringer Ingelheim Investigational Site
City
Künzing
Country
Germany
Facility Name
1218.20.49010 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1218.20.49003 Boehringer Ingelheim Investigational Site
City
Neuwied
Country
Germany
Facility Name
1218.20.49007 Boehringer Ingelheim Investigational Site
City
Nürnberg
Country
Germany
Facility Name
1218.20.49008 Boehringer Ingelheim Investigational Site
City
Rednitzhembach
Country
Germany
Facility Name
1218.20.49027 Boehringer Ingelheim Investigational Site
City
Saaldorf-Surheim
Country
Germany
Facility Name
1218.20.49014 Boehringer Ingelheim Investigational Site
City
Saarbrücken
Country
Germany
Facility Name
1218.20.49030 Boehringer Ingelheim Investigational Site
City
Speyer
Country
Germany
Facility Name
1218.20.49019 Boehringer Ingelheim Investigational Site
City
St. Ingbert/Oberwürzbach
Country
Germany
Facility Name
1218.20.49002 Boehringer Ingelheim Investigational Site
City
Sulzbach-Rosenberg
Country
Germany
Facility Name
1218.20.49009 Boehringer Ingelheim Investigational Site
City
Unterschneidheim
Country
Germany
Facility Name
1218.20.49026 Boehringer Ingelheim Investigational Site
City
Wangen
Country
Germany
Facility Name
1218.20.49011 Boehringer Ingelheim Investigational Site
City
Westerkappeln
Country
Germany
Facility Name
1218.20.49013 Boehringer Ingelheim Investigational Site
City
Würzburg
Country
Germany
Facility Name
1218.20.85201 Boehringer Ingelheim Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
1218.20.85202 Boehringer Ingelheim Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
1218.20.85204 Boehringer Ingelheim Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
1218.20.36208 Boehringer Ingelheim Investigational Site
City
Ajka
Country
Hungary
Facility Name
1218.20.36205 Boehringer Ingelheim Investigational Site
City
Baja
Country
Hungary
Facility Name
1218.20.36204 Boehringer Ingelheim Investigational Site
City
Békéscsaba
Country
Hungary
Facility Name
1218.20.36206 Boehringer Ingelheim Investigational Site
City
Hódmezövásárhely
Country
Hungary
Facility Name
1218.20.36202 Boehringer Ingelheim Investigational Site
City
Makó
Country
Hungary
Facility Name
1218.20.36201 Boehringer Ingelheim Investigational Site
City
Miskolc
Country
Hungary
Facility Name
1218.20.36207 Boehringer Ingelheim Investigational Site
City
Mosonmagyarovar
Country
Hungary
Facility Name
1218.20.36203 Boehringer Ingelheim Investigational Site
City
Szentes
Country
Hungary
Facility Name
1218.20.91022 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1218.20.91024 Boehringer Ingelheim Investigational Site
City
Coimbatore
Country
India
Facility Name
1218.20.91025 Boehringer Ingelheim Investigational Site
City
Gujarat
Country
India
Facility Name
1218.20.91023 Boehringer Ingelheim Investigational Site
City
Hyderabad
Country
India
Facility Name
1218.20.91021 Boehringer Ingelheim Investigational Site
City
Kochi
Country
India
Facility Name
1218.20.91020 Boehringer Ingelheim Investigational Site
City
Mumbai
Country
India
Facility Name
1218.20.91027 Boehringer Ingelheim Investigational Site
City
Patna
Country
India
Facility Name
1218.20.91026 Boehringer Ingelheim Investigational Site
City
Tamilnadu
Country
India
Facility Name
1218.20.35307 Boehringer Ingelheim Investigational Site
City
Co. Cork
Country
Ireland
Facility Name
1218.20.35304 Boehringer Ingelheim Investigational Site
City
Co. Wexford
Country
Ireland
Facility Name
1218.20.35306 Boehringer Ingelheim Investigational Site
City
Co. Wexford
Country
Ireland
Facility Name
1218.20.35310 Boehringer Ingelheim Investigational Site
City
Co. Wexford
Country
Ireland
Facility Name
1218.20.35308 Boehringer Ingelheim Investigational Site
City
Dublin
Country
Ireland
Facility Name
1218.20.35303 Boehringer Ingelheim Investigational Site
City
Waterford
Country
Ireland
Facility Name
1218.20.39034 Boehringer Ingelheim Investigational Site
City
Catania
Country
Italy
Facility Name
1218.20.39027 Boehringer Ingelheim Investigational Site
City
Chieti
Country
Italy
Facility Name
1218.20.39029 Boehringer Ingelheim Investigational Site
City
Codogno (lo)
Country
Italy
Facility Name
1218.20.39021 Boehringer Ingelheim Investigational Site
City
Genova
Country
Italy
Facility Name
1218.20.39033 Boehringer Ingelheim Investigational Site
City
Perugia
Country
Italy
Facility Name
1218.20.39022 Boehringer Ingelheim Investigational Site
City
Pordenone
Country
Italy
Facility Name
1218.20.39028 Boehringer Ingelheim Investigational Site
City
Ravenna
Country
Italy
Facility Name
1218.20.39030 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1218.20.39032 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1218.20.39020 Boehringer Ingelheim Investigational Site
City
Siena
Country
Italy
Facility Name
1218.20.31023 Boehringer Ingelheim Investigational Site
City
's Hertogenbosch
Country
Netherlands
Facility Name
1218.20.31014 Boehringer Ingelheim Investigational Site
City
Almere
Country
Netherlands
Facility Name
1218.20.31016 Boehringer Ingelheim Investigational Site
City
Beek en Donk
Country
Netherlands
Facility Name
1218.20.31011 Boehringer Ingelheim Investigational Site
City
Ewijk
Country
Netherlands
Facility Name
1218.20.31018 Boehringer Ingelheim Investigational Site
City
Hoogwoud
Country
Netherlands
Facility Name
1218.20.31012 Boehringer Ingelheim Investigational Site
City
Oude Pekela
Country
Netherlands
Facility Name
1218.20.31022 Boehringer Ingelheim Investigational Site
City
Rilland
Country
Netherlands
Facility Name
1218.20.31019 Boehringer Ingelheim Investigational Site
City
Roelofarendsveen
Country
Netherlands
Facility Name
1218.20.31013 Boehringer Ingelheim Investigational Site
City
Wildervank
Country
Netherlands
Facility Name
1218.20.47005 Boehringer Ingelheim Investigational Site
City
Fevik
Country
Norway
Facility Name
1218.20.47004 Boehringer Ingelheim Investigational Site
City
Fornebu
Country
Norway
Facility Name
1218.20.47002 Boehringer Ingelheim Investigational Site
City
Hamar
Country
Norway
Facility Name
1218.20.47001 Boehringer Ingelheim Investigational Site
City
RUD
Country
Norway
Facility Name
1218.20.47003 Boehringer Ingelheim Investigational Site
City
Sandvika
Country
Norway
Facility Name
1218.20.48210 Boehringer Ingelheim Investigational Site
City
Bialystok
Country
Poland
Facility Name
1218.20.48208 Boehringer Ingelheim Investigational Site
City
Gdynia
Country
Poland
Facility Name
1218.20.48207 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1218.20.48201 Boehringer Ingelheim Investigational Site
City
Lodz
Country
Poland
Facility Name
1218.20.48202 Boehringer Ingelheim Investigational Site
City
Lodz
Country
Poland
Facility Name
1218.20.48203 Boehringer Ingelheim Investigational Site
City
Olsztyn
Country
Poland
Facility Name
1218.20.48206 Boehringer Ingelheim Investigational Site
City
Torun
Country
Poland
Facility Name
1218.20.48205 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1218.20.48209 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1218.20.27007 Boehringer Ingelheim Investigational Site
City
Bellville
Country
South Africa
Facility Name
1218.20.27002 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
1218.20.27006 Boehringer Ingelheim Investigational Site
City
Durban
Country
South Africa
Facility Name
1218.20.27004 Boehringer Ingelheim Investigational Site
City
Lenasia
Country
South Africa
Facility Name
1218.20.27005 Boehringer Ingelheim Investigational Site
City
Lenasia
Country
South Africa
Facility Name
1218.20.27003 Boehringer Ingelheim Investigational Site
City
Pretoria
Country
South Africa
Facility Name
1218.20.46003 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1218.20.46001 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
1218.20.46002 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
1218.20.46004 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
1218.20.44108 Boehringer Ingelheim Investigational Site
City
Baillieston, Glasgow
Country
United Kingdom
Facility Name
1218.20.44115 Boehringer Ingelheim Investigational Site
City
Blackpool
Country
United Kingdom
Facility Name
1218.20.44110 Boehringer Ingelheim Investigational Site
City
Bradford on Avon
Country
United Kingdom
Facility Name
1218.20.44102 Boehringer Ingelheim Investigational Site
City
Buckshaw Village, Chorley
Country
United Kingdom
Facility Name
1218.20.44114 Boehringer Ingelheim Investigational Site
City
Cheadle
Country
United Kingdom
Facility Name
1218.20.44116 Boehringer Ingelheim Investigational Site
City
Chestfield, Whitstable
Country
United Kingdom
Facility Name
1218.20.44109 Boehringer Ingelheim Investigational Site
City
Chippenham
Country
United Kingdom
Facility Name
1218.20.44113 Boehringer Ingelheim Investigational Site
City
Dundee
Country
United Kingdom
Facility Name
1218.20.44105 Boehringer Ingelheim Investigational Site
City
Edgbaston, Birmingham
Country
United Kingdom
Facility Name
1218.20.44112 Boehringer Ingelheim Investigational Site
City
Ely
Country
United Kingdom
Facility Name
1218.20.44101 Boehringer Ingelheim Investigational Site
City
Guildford
Country
United Kingdom
Facility Name
1218.20.44103 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
1218.20.44106 Boehringer Ingelheim Investigational Site
City
Trowbridge
Country
United Kingdom
Facility Name
1218.20.44104 Boehringer Ingelheim Investigational Site
City
Waterloo, Liverpool
Country
United Kingdom
Facility Name
1218.20.44111 Boehringer Ingelheim Investigational Site
City
Westbury
Country
United Kingdom
Facility Name
1218.20.44107 Boehringer Ingelheim Investigational Site
City
Whitstable
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23521323
Citation
Gallwitz B, Rosenstock J, Emser A, von Eynatten M, Woerle HJ. Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA(1)c < 7% with no hypoglycaemia and no weight gain over 2 years. Int J Clin Pract. 2013 Apr;67(4):317-21. doi: 10.1111/ijcp.12101.
Results Reference
derived
PubMed Identifier
22748821
Citation
Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, Dugi KA, Woerle HJ. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012 Aug 4;380(9840):475-83. doi: 10.1016/S0140-6736(12)60691-6. Epub 2012 Jun 28.
Results Reference
derived
PubMed Identifier
22234149
Citation
Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.20_U11-1485-02.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.20_Literature.pdf
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs