search
Back to results

Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
linagliptin
linagliptin
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 not more than one other oral antidiabetic drug
  2. Diagnosis of type 2 diabetes prior to informed consent

  3. Glycosylated haemoglobin A1 (HbA1c)at screening:

    For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%

  4. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
  5. Age 18 -80 years
  6. BMI (Body Mass Index) less than 40 kg/m2
  7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria:

  1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  2. Impaired hepatic function
  3. Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
  4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
  5. Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
  6. Treatment with insulin within 3 months prior to informed consent
  7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
  8. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
  9. Participation in another trial with an investigational drug within 2 months prior to informed consent

  10. Pre-menopausal women 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 submit to periodic pregnancy testing during participation in the trial.
  11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
  12. Renal failure or renal impairment
  13. Unstable or acute congestive heart failure
  14. Acute or chronic metabolic acidosis (present in patient history)
  15. Hereditary galactose intolerance

Sites / Locations

  • 1218.17.10003 Boehringer Ingelheim Investigational Site
  • 1218.17.10014 Boehringer Ingelheim Investigational Site
  • 1218.17.10001 Boehringer Ingelheim Investigational Site
  • 1218.17.10021 Boehringer Ingelheim Investigational Site
  • 1218.17.10010 Boehringer Ingelheim Investigational Site
  • 1218.17.10011 Boehringer Ingelheim Investigational Site
  • 1218.17.10008 Boehringer Ingelheim Investigational Site
  • 1218.17.10017 Boehringer Ingelheim Investigational Site
  • 1218.17.10006 Boehringer Ingelheim Investigational Site
  • 1218.17.10012 Boehringer Ingelheim Investigational Site
  • 1218.17.10013 Boehringer Ingelheim Investigational Site
  • 1218.17.10015 Boehringer Ingelheim Investigational Site
  • 1218.17.10016 Boehringer Ingelheim Investigational Site
  • 1218.17.10002 Boehringer Ingelheim Investigational Site
  • 1218.17.10004 Boehringer Ingelheim Investigational Site
  • 1218.17.10005 Boehringer Ingelheim Investigational Site
  • 1218.17.10018 Boehringer Ingelheim Investigational Site
  • 1218.17.10007 Boehringer Ingelheim Investigational Site
  • 1218.17.10009 Boehringer Ingelheim Investigational Site
  • 1218.17.42006 Boehringer Ingelheim Investigational Site
  • 1218.17.42001 Boehringer Ingelheim Investigational Site
  • 1218.17.42004 Boehringer Ingelheim Investigational Site
  • 1218.17.42007 Boehringer Ingelheim Investigational Site
  • 1218.17.42009 Boehringer Ingelheim Investigational Site
  • 1218.17.42008 Boehringer Ingelheim Investigational Site
  • 1218.17.42003 Boehringer Ingelheim Investigational Site
  • 1218.17.35806 Boehringer Ingelheim Investigational Site
  • 1218.17.35804 Boehringer Ingelheim Investigational Site
  • 1218.17.35801 Boehringer Ingelheim Investigational Site
  • 1218.17.35803 Boehringer Ingelheim Investigational Site
  • 1218.17.35805 Boehringer Ingelheim Investigational Site
  • 1218.17.35802 Boehringer Ingelheim Investigational Site
  • 1218.17.30004 Boehringer Ingelheim Investigational Site
  • 1218.17.30013 Boehringer Ingelheim Investigational Site
  • 1218.17.30011 Boehringer Ingelheim Investigational Site
  • 1218.17.91009 Boehringer Ingelheim Investigational Site
  • 1218.17.91002 Boehringer Ingelheim Investigational Site
  • 1218.17.91005 Boehringer Ingelheim Investigational Site
  • 1218.17.91012 Boehringer Ingelheim Investigational Site
  • 1218.17.91014 Boehringer Ingelheim Investigational Site
  • 1218.17.91010 Boehringer Ingelheim Investigational Site
  • 1218.17.91006 Boehringer Ingelheim Investigational Site
  • 1218.17.91007 Boehringer Ingelheim Investigational Site
  • 1218.17.91008 Boehringer Ingelheim Investigational Site
  • 1218.17.91004 Boehringer Ingelheim Investigational Site
  • 1218.17.91011 Boehringer Ingelheim Investigational Site
  • 1218.17.91003 Boehringer Ingelheim Investigational Site
  • 1218.17.91001 Boehringer Ingelheim Investigational Site
  • 1218.17.91013 Boehringer Ingelheim Investigational Site
  • 1218.17.97274 Boehringer Ingelheim Investigational Site
  • 1218.17.97273 Boehringer Ingelheim Investigational Site
  • 1218.17.97275 Boehringer Ingelheim Investigational Site
  • 1218.17.97271 Boehringer Ingelheim Investigational Site
  • 1218.17.97272 Boehringer Ingelheim Investigational Site
  • 1218.17.97276 Boehringer Ingelheim Investigational Site
  • 1218.17.97278 Boehringer Ingelheim Investigational Site
  • 1218.17.52007 Boehringer Ingelheim Investigational Site
  • 1218.17.52009 Boehringer Ingelheim Investigational Site
  • 1218.17.52003 Boehringer Ingelheim Investigational Site
  • 1218.17.52001 Boehringer Ingelheim Investigational Site
  • 1218.17.52010 Boehringer Ingelheim Investigational Site
  • 1218.17.52005 Boehringer Ingelheim Investigational Site
  • 1218.17.52008 Boehringer Ingelheim Investigational Site
  • 1218.17.52006 Boehringer Ingelheim Investigational Site
  • 1218.17.52002 Boehringer Ingelheim Investigational Site
  • 1218.17.52004 Boehringer Ingelheim Investigational Site
  • 1218.17.64004 Boehringer Ingelheim Investigational Site
  • 1218.17.64003 Boehringer Ingelheim Investigational Site
  • 1218.17.64002 Boehringer Ingelheim Investigational Site
  • 1218.17.64001 Boehringer Ingelheim Investigational Site
  • 1218.17.64005 Boehringer Ingelheim Investigational Site
  • 1218.17.70001 Boehringer Ingelheim Investigational Site
  • 1218.17.70002 Boehringer Ingelheim Investigational Site
  • 1218.17.70003 Boehringer Ingelheim Investigational Site
  • 1218.17.70005 Boehringer Ingelheim Investigational Site
  • 1218.17.70006 Boehringer Ingelheim Investigational Site
  • 1218.17.70004 Boehringer Ingelheim Investigational Site
  • 1218.17.46013 Boehringer Ingelheim Investigational Site
  • 1218.17.46001 Boehringer Ingelheim Investigational Site
  • 1218.17.46012 Boehringer Ingelheim Investigational Site
  • 1218.17.46004 Boehringer Ingelheim Investigational Site
  • 1218.17.46015 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Linagliptin

Placebo

Arm Description

Patients receive linagliptin 5 mg tablets once daily

Patients receive placebo tablets matching linagliptin 5 mg tablets once daily

Outcomes

Primary Outcome Measures

HbA1c Change From Baseline at 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 at 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 at 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 at 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 at 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 at 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 at 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 at Week 18
This change from baseline reflects the Week 18 FPG minus the baseline 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 7.0% 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 >= 7.0%. 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 7.0% 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 >= 7.0%.
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 >= 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 >= 6.5%.
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24
The percentage of patients with an HbA1c reduction from baseline >= 0.5% 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 reduction less than 0.5%.
Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24
This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.
2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24
This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.

Full Information

First Posted
January 15, 2008
Last Updated
December 11, 2013
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00601250
Brief Title
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
Official Title
A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), 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
January 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 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
701 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Linagliptin
Arm Type
Experimental
Arm Description
Patients receive linagliptin 5 mg tablets once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo tablets matching linagliptin 5 mg tablets once daily
Intervention Type
Drug
Intervention Name(s)
linagliptin
Intervention Description
Patients receive linagliptin 5 mg tablets once daily
Intervention Type
Drug
Intervention Name(s)
linagliptin
Intervention Description
Patients receive linagliptin 5 mg tablets once daily
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline at 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 at 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 at 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 at 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 at 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 at 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 at 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 at Week 18
Description
This change from baseline reflects the Week 18 FPG minus the baseline 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 7.0% 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 >= 7.0%. 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 7.0% 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 >= 7.0%.
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 >= 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 >= 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 from baseline >= 0.5% 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 reduction less than 0.5%.
Time Frame
Baseline and week 24
Title
Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24
Description
This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.
Time Frame
Baseline and week 24
Title
2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24
Description
This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.
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 and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug Diagnosis of type 2 diabetes prior to informed consent Glycosylated haemoglobin A1 (HbA1c)at screening: For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0% Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in Age 18 -80 years BMI (Body Mass Index) less than 40 kg/m2 Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation Exclusion criteria: Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent Impaired hepatic function Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent Treatment with insulin within 3 months prior to informed consent Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse Participation in another trial with an investigational drug within 2 months prior to informed consent Pre-menopausal women 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 submit to periodic pregnancy testing during participation in the trial. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. Renal failure or renal impairment Unstable or acute congestive heart failure Acute or chronic metabolic acidosis (present in patient history) Hereditary galactose intolerance
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
1218.17.10003 Boehringer Ingelheim Investigational Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
1218.17.10014 Boehringer Ingelheim Investigational Site
City
Spring Valley
State/Province
California
Country
United States
Facility Name
1218.17.10001 Boehringer Ingelheim Investigational Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
1218.17.10021 Boehringer Ingelheim Investigational Site
City
Northglenn
State/Province
Colorado
Country
United States
Facility Name
1218.17.10010 Boehringer Ingelheim Investigational Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
1218.17.10011 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1218.17.10008 Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
1218.17.10017 Boehringer Ingelheim Investigational Site
City
Gurnee
State/Province
Illinois
Country
United States
Facility Name
1218.17.10006 Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
1218.17.10012 Boehringer Ingelheim Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
1218.17.10013 Boehringer Ingelheim Investigational Site
City
Mentor
State/Province
Ohio
Country
United States
Facility Name
1218.17.10015 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
1218.17.10016 Boehringer Ingelheim Investigational Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
1218.17.10002 Boehringer Ingelheim Investigational Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
1218.17.10004 Boehringer Ingelheim Investigational Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
1218.17.10005 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1218.17.10018 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1218.17.10007 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1218.17.10009 Boehringer Ingelheim Investigational Site
City
Federal Way
State/Province
Washington
Country
United States
Facility Name
1218.17.42006 Boehringer Ingelheim Investigational Site
City
Breclav
Country
Czech Republic
Facility Name
1218.17.42001 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
1218.17.42004 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
1218.17.42007 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
1218.17.42009 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
1218.17.42008 Boehringer Ingelheim Investigational Site
City
Hodonin
Country
Czech Republic
Facility Name
1218.17.42003 Boehringer Ingelheim Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
1218.17.35806 Boehringer Ingelheim Investigational Site
City
Helsinki
Country
Finland
Facility Name
1218.17.35804 Boehringer Ingelheim Investigational Site
City
Jyväskylä
Country
Finland
Facility Name
1218.17.35801 Boehringer Ingelheim Investigational Site
City
Kuopio
Country
Finland
Facility Name
1218.17.35803 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
1218.17.35805 Boehringer Ingelheim Investigational Site
City
Seinäjoki
Country
Finland
Facility Name
1218.17.35802 Boehringer Ingelheim Investigational Site
City
Turku
Country
Finland
Facility Name
1218.17.30004 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1218.17.30013 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1218.17.30011 Boehringer Ingelheim Investigational Site
City
Piraeus
Country
Greece
Facility Name
1218.17.91009 Boehringer Ingelheim Investigational Site
City
Andhra Pradesh
Country
India
Facility Name
1218.17.91002 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1218.17.91005 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1218.17.91012 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1218.17.91014 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1218.17.91010 Boehringer Ingelheim Investigational Site
City
Hyderabad
Country
India
Facility Name
1218.17.91006 Boehringer Ingelheim Investigational Site
City
Jaipur
Country
India
Facility Name
1218.17.91007 Boehringer Ingelheim Investigational Site
City
Karnataka
Country
India
Facility Name
1218.17.91008 Boehringer Ingelheim Investigational Site
City
Mangalore
Country
India
Facility Name
1218.17.91004 Boehringer Ingelheim Investigational Site
City
Mumbai
Country
India
Facility Name
1218.17.91011 Boehringer Ingelheim Investigational Site
City
Nagpur
Country
India
Facility Name
1218.17.91003 Boehringer Ingelheim Investigational Site
City
Nasik
Country
India
Facility Name
1218.17.91001 Boehringer Ingelheim Investigational Site
City
Trivandrum
Country
India
Facility Name
1218.17.91013 Boehringer Ingelheim Investigational Site
City
Uttar Pradesh
Country
India
Facility Name
1218.17.97274 Boehringer Ingelheim Investigational Site
City
Afula
Country
Israel
Facility Name
1218.17.97273 Boehringer Ingelheim Investigational Site
City
Haifa
Country
Israel
Facility Name
1218.17.97275 Boehringer Ingelheim Investigational Site
City
Holon
Country
Israel
Facility Name
1218.17.97271 Boehringer Ingelheim Investigational Site
City
Jerusalem
Country
Israel
Facility Name
1218.17.97272 Boehringer Ingelheim Investigational Site
City
Nahariya
Country
Israel
Facility Name
1218.17.97276 Boehringer Ingelheim Investigational Site
City
Safed
Country
Israel
Facility Name
1218.17.97278 Boehringer Ingelheim Investigational Site
City
Tel Aviv
Country
Israel
Facility Name
1218.17.52007 Boehringer Ingelheim Investigational Site
City
Aguascalientes, Ags.
Country
Mexico
Facility Name
1218.17.52009 Boehringer Ingelheim Investigational Site
City
cOL OBREGON,León, Guanajuato
Country
Mexico
Facility Name
1218.17.52003 Boehringer Ingelheim Investigational Site
City
Col. Lomas de San Francisco, Monterrey
Country
Mexico
Facility Name
1218.17.52001 Boehringer Ingelheim Investigational Site
City
Col. Mitras Centro, Monterrey, N.L.
Country
Mexico
Facility Name
1218.17.52010 Boehringer Ingelheim Investigational Site
City
Col.Americana, Guadalajara, Jalisco
Country
Mexico
Facility Name
1218.17.52005 Boehringer Ingelheim Investigational Site
City
Colonia Reforma Social
Country
Mexico
Facility Name
1218.17.52008 Boehringer Ingelheim Investigational Site
City
Colonia Tlalpan, mexico
Country
Mexico
Facility Name
1218.17.52006 Boehringer Ingelheim Investigational Site
City
Faccionamiento Lomas de Campestre,AGUASCAL
Country
Mexico
Facility Name
1218.17.52002 Boehringer Ingelheim Investigational Site
City
Mexico
Country
Mexico
Facility Name
1218.17.52004 Boehringer Ingelheim Investigational Site
City
Tlalpan-México D,F
Country
Mexico
Facility Name
1218.17.64004 Boehringer Ingelheim Investigational Site
City
Christchurch
Country
New Zealand
Facility Name
1218.17.64003 Boehringer Ingelheim Investigational Site
City
Dunedin
Country
New Zealand
Facility Name
1218.17.64002 Boehringer Ingelheim Investigational Site
City
Otahuhu
Country
New Zealand
Facility Name
1218.17.64001 Boehringer Ingelheim Investigational Site
City
Tauranga
Country
New Zealand
Facility Name
1218.17.64005 Boehringer Ingelheim Investigational Site
City
Wellington
Country
New Zealand
Facility Name
1218.17.70001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1218.17.70002 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1218.17.70003 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1218.17.70005 Boehringer Ingelheim Investigational Site
City
Novosibirsk
Country
Russian Federation
Facility Name
1218.17.70006 Boehringer Ingelheim Investigational Site
City
Perm
Country
Russian Federation
Facility Name
1218.17.70004 Boehringer Ingelheim Investigational Site
City
Tomsk
Country
Russian Federation
Facility Name
1218.17.46013 Boehringer Ingelheim Investigational Site
City
Härnösand
Country
Sweden
Facility Name
1218.17.46001 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
1218.17.46012 Boehringer Ingelheim Investigational Site
City
Uddevalla
Country
Sweden
Facility Name
1218.17.46004 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
1218.17.46015 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden

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
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.17_U09-2533.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.17_Literature.pdf
Description
Related Info

Learn more about this trial

Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

We'll reach out to this number within 24 hrs