search
Back to results

BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
linagliptin
placebo
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, currently treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
  2. Glycosylated haemoglobin A1 (HbA1c) >/= 7.0 and </= 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase)
  3. Age >/= 18 and </= 80 years at Visit 1a (screening)
  4. BMI (Body Mass Index) </= 40 kg/m2 at Visit 1a (screening)
  5. Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation *Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.

Exclusion criteria:

  1. Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent
  2. Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
  3. Renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at Visit 1a
  4. Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
  5. Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
  6. Treatment with insulin within 3 months prior to the date of informed consent
  7. Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
  8. Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent

  9. Pre-menopausal women (last menstruation </= 1 year prior to the date of informed consent) who:

    • are nursing or pregnant
    • or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
  10. Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
  11. Dehydration (as confirmed by the Investigators clinical opinion)
  12. Current acute or chronic metabolic acidosis

Sites / Locations

  • 1218.18.54001 Boehringer Ingelheim Investigational Site
  • 1218.18.54002 Boehringer Ingelheim Investigational Site
  • 1218.18.54004 Boehringer Ingelheim Investigational Site
  • 1218.18.54005 Boehringer Ingelheim Investigational Site
  • 1218.18.54010 Boehringer Ingelheim Investigational Site
  • 1218.18.54014 Boehringer Ingelheim Investigational Site
  • 1218.18.54009 Boehringer Ingelheim Investigational Site
  • 1218.18.54013 Boehringer Ingelheim Investigational Site
  • 1218.18.54003 Boehringer Ingelheim Investigational Site
  • 1218.18.54012 Boehringer Ingelheim Investigational Site
  • 1218.18.54011 Boehringer Ingelheim Investigational Site
  • 1218.18.54015 Boehringer Ingelheim Investigational Site
  • 1218.18.54006 Boehringer Ingelheim Investigational Site
  • 1218.18.54007 Boehringer Ingelheim Investigational Site
  • 1218.18.32005 Boehringer Ingelheim Investigational Site
  • 1218.18.32007 Boehringer Ingelheim Investigational Site
  • 1218.18.32006 Boehringer Ingelheim Investigational Site
  • 1218.18.32004 Boehringer Ingelheim Investigational Site
  • 1218.18.32003 Boehringer Ingelheim Investigational Site
  • 1218.18.32002 Boehringer Ingelheim Investigational Site
  • 1218.18.32001 Boehringer Ingelheim Investigational Site
  • 1218.18.01005 Boehringer Ingelheim Investigational Site
  • 1218.18.01010 Boehringer Ingelheim Investigational Site
  • 1218.18.01003 Boehringer Ingelheim Investigational Site
  • 1218.18.01011 Boehringer Ingelheim Investigational Site
  • 1218.18.01006 Boehringer Ingelheim Investigational Site
  • 1218.18.01009 Boehringer Ingelheim Investigational Site
  • 1218.18.01002 Boehringer Ingelheim Investigational Site
  • 1218.18.01012 Boehringer Ingelheim Investigational Site
  • 1218.18.01008 Boehringer Ingelheim Investigational Site
  • 1218.18.01001 Boehringer Ingelheim Investigational Site
  • 1218.18.01004 Boehringer Ingelheim Investigational Site
  • 1218.18.01007 Boehringer Ingelheim Investigational Site
  • 1218.18.86001 Boehringer Ingelheim Investigational Site
  • 1218.18.86002 Boehringer Ingelheim Investigational Site
  • 1218.18.86004 Boehringer Ingelheim Investigational Site
  • 1218.18.86013 Boehringer Ingelheim Investigational Site
  • 1218.18.86009 Boehringer Ingelheim Investigational Site
  • 1218.18.86011 Boehringer Ingelheim Investigational Site
  • 1218.18.86014 Boehringer Ingelheim Investigational Site
  • 1218.18.86005 Boehringer Ingelheim Investigational Site
  • 1218.18.86008 Boehringer Ingelheim Investigational Site
  • 1218.18.86015 Boehringer Ingelheim Investigational Site
  • 1218.18.86010 Boehringer Ingelheim Investigational Site
  • 1218.18.86003 Boehringer Ingelheim Investigational Site
  • 1218.18.86012 Boehringer Ingelheim Investigational Site
  • 1218.18.86007 Boehringer Ingelheim Investigational Site
  • 1218.18.86006 Boehringer Ingelheim Investigational Site
  • 1218.18.49004 Boehringer Ingelheim Investigational Site
  • 1218.18.49028 Boehringer Ingelheim Investigational Site
  • 1218.18.49022 Boehringer Ingelheim Investigational Site
  • 1218.18.49024 Boehringer Ingelheim Investigational Site
  • 1218.18.49020 Boehringer Ingelheim Investigational Site
  • 1218.18.49101 Boehringer Ingelheim Investigational Site
  • 1218.18.49003 Boehringer Ingelheim Investigational Site
  • 1218.18.49007 Boehringer Ingelheim Investigational Site
  • 1218.18.49014 Boehringer Ingelheim Investigational Site
  • 1218.18.82004 Boehringer Ingelheim Investigational Site
  • 1218.18.82011 Boehringer Ingelheim Investigational Site
  • 1218.18.82008 Boehringer Ingelheim Investigational Site
  • 1218.18.82010 Boehringer Ingelheim Investigational Site
  • 1218.18.82002 Boehringer Ingelheim Investigational Site
  • 1218.18.82001 Boehringer Ingelheim Investigational Site
  • 1218.18.82005 Boehringer Ingelheim Investigational Site
  • 1218.18.82006 Boehringer Ingelheim Investigational Site
  • 1218.18.82007 Boehringer Ingelheim Investigational Site
  • 1218.18.82009 Boehringer Ingelheim Investigational Site
  • 1218.18.82003 Boehringer Ingelheim Investigational Site
  • 1218.18.63005 Boehringer Ingelheim Investigational Site
  • 1218.18.63002 Boehringer Ingelheim Investigational Site
  • 1218.18.63001 Boehringer Ingelheim Investigational Site
  • 1218.18.63004 Boehringer Ingelheim Investigational Site
  • 1218.18.63003 Boehringer Ingelheim Investigational Site
  • 1218.18.70014 Boehringer Ingelheim Investigational Site
  • 1218.18.70012 Boehringer Ingelheim Investigational Site
  • 1218.18.70013 Boehringer Ingelheim Investigational Site
  • 1218.18.70016 Boehringer Ingelheim Investigational Site
  • 1218.18.70015 Boehringer Ingelheim Investigational Site
  • 1218.18.88605 Boehringer Ingelheim Investigational Site
  • 1218.18.88604 Boehringer Ingelheim Investigational Site
  • 1218.18.88606 Boehringer Ingelheim Investigational Site
  • 1218.18.88601 Boehringer Ingelheim Investigational Site
  • 1218.18.88602 Boehringer Ingelheim Investigational Site
  • 1218.18.88603 Boehringer Ingelheim Investigational Site
  • 1218.18.88607 Boehringer Ingelheim Investigational Site
  • 1218.18.88608 Boehringer Ingelheim Investigational Site
  • 1218.18.90003 Boehringer Ingelheim Investigational Site
  • 1218.18.90005 Boehringer Ingelheim Investigational Site
  • 1218.18.90001 Boehringer Ingelheim Investigational Site
  • 1218.18.90004 Boehringer Ingelheim Investigational Site
  • 1218.18.44005 Boehringer Ingelheim Investigational Site
  • 1218.18.44004 Boehringer Ingelheim Investigational Site
  • 1218.18.44001 Boehringer Ingelheim Investigational Site
  • 1218.18.44003 Boehringer Ingelheim Investigational Site
  • 1218.18.44010 Boehringer Ingelheim Investigational Site
  • 1218.18.44009 Boehringer Ingelheim Investigational Site
  • 1218.18.44008 Boehringer Ingelheim Investigational Site
  • 1218.18.44002 Boehringer Ingelheim Investigational Site
  • 1218.18.44006 Boehringer Ingelheim Investigational Site
  • 1218.18.44007 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

linagliptin 5 mg

placebo

Arm Description

linagliptin 5 mg once daily

placebo matching linagliptin 5 mg tablets

Outcomes

Primary Outcome Measures

HbA1c Change From Baseline to Week 24
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

Secondary Outcome Measures

HbA1c Change From Baseline to Week 6
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
HbA1c Change From Baseline to Week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
HbA1c Change From Baseline to Week 18
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
FPG Change From Baseline to Week 24
This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline to Week 6
This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline to Week 12
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline to Week 18
This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication
Percentage of Patients With HbA1c <7.0% at Week 24
The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%
Percentage of Patients With HbA1c < 7.0% at Week 24
The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Percentage of Patients With HbA1c <6.5% at Week 24
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%
Percentage of Patients With HbA1c<6.5% at Week 24
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24
The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%

Full Information

First Posted
January 15, 2008
Last Updated
February 27, 2014
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00602472
Brief Title
BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
Official Title
A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg) Administered Orally Once Daily Over 24 Weeks, With an Open-label Extension to One Year (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With a Sulphonylurea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea 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
1058 (Actual)

8. Arms, Groups, and Interventions

Arm Title
linagliptin 5 mg
Arm Type
Experimental
Arm Description
linagliptin 5 mg once daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo matching linagliptin 5 mg tablets
Intervention Type
Drug
Intervention Name(s)
linagliptin
Intervention Description
active
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo to linagliptin 5 mg
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline to Week 24
Description
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Time Frame
Baseline and week 24
Secondary Outcome Measure Information:
Title
HbA1c Change From Baseline to Week 6
Description
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Time Frame
Baseline and week 6
Title
HbA1c Change From Baseline to Week 12
Description
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Time Frame
Baseline and week 12
Title
HbA1c Change From Baseline to Week 18
Description
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Time Frame
Baseline and week 18
Title
FPG Change From Baseline to Week 24
Description
This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Time Frame
Baseline and week 24
Title
FPG Change From Baseline to Week 6
Description
This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Time Frame
Baseline and week 6
Title
FPG Change From Baseline to Week 12
Description
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Time Frame
Baseline and week 12
Title
FPG Change From Baseline to Week 18
Description
This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication
Time Frame
Baseline and week 18
Title
Percentage of Patients With HbA1c <7.0% at Week 24
Description
The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%
Time Frame
Baseline and week 24
Title
Percentage of Patients With HbA1c < 7.0% at Week 24
Description
The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Time Frame
Baseline and week 24
Title
Percentage of Patients With HbA1c <6.5% at Week 24
Description
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%
Time Frame
Baseline and week 24
Title
Percentage of Patients With HbA1c<6.5% at Week 24
Description
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%
Time Frame
Baseline and week 24
Title
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24
Description
The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%
Time Frame
Baseline and week 24

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, currently treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial Glycosylated haemoglobin A1 (HbA1c) >/= 7.0 and </= 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase) Age >/= 18 and </= 80 years at Visit 1a (screening) BMI (Body Mass Index) </= 40 kg/m2 at Visit 1a (screening) Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation *Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient. Exclusion criteria: Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a Renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at Visit 1a Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent Treatment with insulin within 3 months prior to the date of informed consent Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent Pre-menopausal women (last menstruation </= 1 year prior to the date of informed consent) who: are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made. Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides Dehydration (as confirmed by the Investigators clinical opinion) Current acute or chronic metabolic acidosis
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
1218.18.54001 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1218.18.54002 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1218.18.54004 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1218.18.54005 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1218.18.54010 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1218.18.54014 Boehringer Ingelheim Investigational Site
City
Corrientes
Country
Argentina
Facility Name
1218.18.54009 Boehringer Ingelheim Investigational Site
City
Córdoba
Country
Argentina
Facility Name
1218.18.54013 Boehringer Ingelheim Investigational Site
City
Córdoba
Country
Argentina
Facility Name
1218.18.54003 Boehringer Ingelheim Investigational Site
City
Mar del Plata
Country
Argentina
Facility Name
1218.18.54012 Boehringer Ingelheim Investigational Site
City
Mar del Plata
Country
Argentina
Facility Name
1218.18.54011 Boehringer Ingelheim Investigational Site
City
Mendoza
Country
Argentina
Facility Name
1218.18.54015 Boehringer Ingelheim Investigational Site
City
Parque Velez Sarfield
Country
Argentina
Facility Name
1218.18.54006 Boehringer Ingelheim Investigational Site
City
Rosario
Country
Argentina
Facility Name
1218.18.54007 Boehringer Ingelheim Investigational Site
City
Salta
Country
Argentina
Facility Name
1218.18.32005 Boehringer Ingelheim Investigational Site
City
Brugge
Country
Belgium
Facility Name
1218.18.32007 Boehringer Ingelheim Investigational Site
City
Brussel
Country
Belgium
Facility Name
1218.18.32006 Boehringer Ingelheim Investigational Site
City
Edegem
Country
Belgium
Facility Name
1218.18.32004 Boehringer Ingelheim Investigational Site
City
Genk
Country
Belgium
Facility Name
1218.18.32003 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1218.18.32002 Boehringer Ingelheim Investigational Site
City
Huy
Country
Belgium
Facility Name
1218.18.32001 Boehringer Ingelheim Investigational Site
City
Liège
Country
Belgium
Facility Name
1218.18.01005 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1218.18.01010 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1218.18.01003 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1218.18.01011 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1218.18.01006 Boehringer Ingelheim Investigational Site
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
1218.18.01009 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1218.18.01002 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1218.18.01012 Boehringer Ingelheim Investigational Site
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
1218.18.01008 Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
1218.18.01001 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1218.18.01004 Boehringer Ingelheim Investigational Site
City
Montague
State/Province
Prince Edward Island
Country
Canada
Facility Name
1218.18.01007 Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
1218.18.86001 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1218.18.86002 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1218.18.86004 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1218.18.86013 Boehringer Ingelheim Investigational Site
City
Chengdu, Sichuan Province
Country
China
Facility Name
1218.18.86009 Boehringer Ingelheim Investigational Site
City
Dalian
Country
China
Facility Name
1218.18.86011 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1218.18.86014 Boehringer Ingelheim Investigational Site
City
Haerbin
Country
China
Facility Name
1218.18.86005 Boehringer Ingelheim Investigational Site
City
Nanjing, Jiangsu Province
Country
China
Facility Name
1218.18.86008 Boehringer Ingelheim Investigational Site
City
Qingdao
Country
China
Facility Name
1218.18.86015 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1218.18.86010 Boehringer Ingelheim Investigational Site
City
Shen Yang
Country
China
Facility Name
1218.18.86003 Boehringer Ingelheim Investigational Site
City
Weizikeng
Country
China
Facility Name
1218.18.86012 Boehringer Ingelheim Investigational Site
City
Wuhan, Hubei Province
Country
China
Facility Name
1218.18.86007 Boehringer Ingelheim Investigational Site
City
Wuhan
Country
China
Facility Name
1218.18.86006 Boehringer Ingelheim Investigational Site
City
Xian, Shanxi Province
Country
China
Facility Name
1218.18.49004 Boehringer Ingelheim Investigational Site
City
Aschaffenburg
Country
Germany
Facility Name
1218.18.49028 Boehringer Ingelheim Investigational Site
City
Bad Mergentheim
Country
Germany
Facility Name
1218.18.49022 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1218.18.49024 Boehringer Ingelheim Investigational Site
City
Bosenheim
Country
Germany
Facility Name
1218.18.49020 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1218.18.49101 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1218.18.49003 Boehringer Ingelheim Investigational Site
City
Neuwied
Country
Germany
Facility Name
1218.18.49007 Boehringer Ingelheim Investigational Site
City
Nürnberg
Country
Germany
Facility Name
1218.18.49014 Boehringer Ingelheim Investigational Site
City
Saarbrücken
Country
Germany
Facility Name
1218.18.82004 Boehringer Ingelheim Investigational Site
City
Busan
Country
Korea, Republic of
Facility Name
1218.18.82011 Boehringer Ingelheim Investigational Site
City
Daegu
Country
Korea, Republic of
Facility Name
1218.18.82008 Boehringer Ingelheim Investigational Site
City
Incheon
Country
Korea, Republic of
Facility Name
1218.18.82010 Boehringer Ingelheim Investigational Site
City
Jeonju
Country
Korea, Republic of
Facility Name
1218.18.82002 Boehringer Ingelheim Investigational Site
City
Pusan
Country
Korea, Republic of
Facility Name
1218.18.82001 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1218.18.82005 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1218.18.82006 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1218.18.82007 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1218.18.82009 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1218.18.82003 Boehringer Ingelheim Investigational Site
City
Suwon
Country
Korea, Republic of
Facility Name
1218.18.63005 Boehringer Ingelheim Investigational Site
City
Manila
Country
Philippines
Facility Name
1218.18.63002 Boehringer Ingelheim Investigational Site
City
Marikina
Country
Philippines
Facility Name
1218.18.63001 Boehringer Ingelheim Investigational Site
City
Pasig
Country
Philippines
Facility Name
1218.18.63004 Boehringer Ingelheim Investigational Site
City
Quezon City
Country
Philippines
Facility Name
1218.18.63003 Boehringer Ingelheim Investigational Site
City
San Juan
Country
Philippines
Facility Name
1218.18.70014 Boehringer Ingelheim Investigational Site
City
Arkhangelsk
Country
Russian Federation
Facility Name
1218.18.70012 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1218.18.70013 Boehringer Ingelheim Investigational Site
City
Rostov-on-Don
Country
Russian Federation
Facility Name
1218.18.70016 Boehringer Ingelheim Investigational Site
City
Samara
Country
Russian Federation
Facility Name
1218.18.70015 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1218.18.88605 Boehringer Ingelheim Investigational Site
City
Changhua
Country
Taiwan
Facility Name
1218.18.88604 Boehringer Ingelheim Investigational Site
City
Taichung
Country
Taiwan
Facility Name
1218.18.88606 Boehringer Ingelheim Investigational Site
City
Tainan
Country
Taiwan
Facility Name
1218.18.88601 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1218.18.88602 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1218.18.88603 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1218.18.88607 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1218.18.88608 Boehringer Ingelheim Investigational Site
City
Taoyuan
Country
Taiwan
Facility Name
1218.18.90003 Boehringer Ingelheim Investigational Site
City
Erzurum
Country
Turkey
Facility Name
1218.18.90005 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1218.18.90001 Boehringer Ingelheim Investigational Site
City
Izmir
Country
Turkey
Facility Name
1218.18.90004 Boehringer Ingelheim Investigational Site
City
Konya
Country
Turkey
Facility Name
1218.18.44005 Boehringer Ingelheim Investigational Site
City
Ashford
Country
United Kingdom
Facility Name
1218.18.44004 Boehringer Ingelheim Investigational Site
City
Baillieston, Glasgow
Country
United Kingdom
Facility Name
1218.18.44001 Boehringer Ingelheim Investigational Site
City
Bath
Country
United Kingdom
Facility Name
1218.18.44003 Boehringer Ingelheim Investigational Site
City
Burbage
Country
United Kingdom
Facility Name
1218.18.44010 Boehringer Ingelheim Investigational Site
City
Bury St Edmonds
Country
United Kingdom
Facility Name
1218.18.44009 Boehringer Ingelheim Investigational Site
City
Cardiff
Country
United Kingdom
Facility Name
1218.18.44008 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
1218.18.44002 Boehringer Ingelheim Investigational Site
City
Penarth
Country
United Kingdom
Facility Name
1218.18.44006 Boehringer Ingelheim Investigational Site
City
Reading
Country
United Kingdom
Facility Name
1218.18.44007 Boehringer Ingelheim Investigational Site
City
Waterloo, Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27484756
Citation
Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
Results Reference
derived
PubMed Identifier
23672632
Citation
Zeng Z, Yang JK, Tong N, Yan S, Zhang X, Gong Y, Woerle HJ. Efficacy and safety of linagliptin added to metformin and sulphonylurea in Chinese patients with type 2 diabetes: a sub-analysis of data from a randomised clinical trial. Curr Med Res Opin. 2013 Aug;29(8):921-9. doi: 10.1185/03007995.2013.805123. Epub 2013 Jun 4.
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
PubMed Identifier
21781152
Citation
Owens DR, Swallow R, Dugi KA, Woerle HJ. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Diabet Med. 2011 Nov;28(11):1352-61. doi: 10.1111/j.1464-5491.2011.03387.x. Erratum In: Diabet Med. 2012 Jan;29(1):158.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.18_U09-2458.pdf
Description
Related Info

Learn more about this trial

BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes

We'll reach out to this number within 24 hrs