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Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BI 1356
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:

  • Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
  • Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
  • Age 18 or over and not older than 80 years

Exclusion criteria:

  • Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
  • Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  • Unstable or acute congestive heart failure

Sites / Locations

  • 1218.43.10027 Boehringer Ingelheim Investigational Site
  • 1218.43.10011 Boehringer Ingelheim Investigational Site
  • 1218.43.10006 Boehringer Ingelheim Investigational Site
  • 1218.43.10021 Boehringer Ingelheim Investigational Site
  • 1218.43.10013 Boehringer Ingelheim Investigational Site
  • 1218.43.10009 Boehringer Ingelheim Investigational Site
  • 1218.43.10018 Boehringer Ingelheim Investigational Site
  • 1218.43.10022 Boehringer Ingelheim Investigational Site
  • 1218.43.10015 Boehringer Ingelheim Investigational Site
  • 1218.43.10016 Boehringer Ingelheim Investigational Site
  • 1218.43.10004 Boehringer Ingelheim Investigational Site
  • 1218.43.10003 Boehringer Ingelheim Investigational Site
  • 1218.43.10020 Boehringer Ingelheim Investigational Site
  • 1218.43.10019 Boehringer Ingelheim Investigational Site
  • 1218.43.10008 Boehringer Ingelheim Investigational Site
  • 1218.43.10005 Boehringer Ingelheim Investigational Site
  • 1218.43.10007 Boehringer Ingelheim Investigational Site
  • 1218.43.10001 Boehringer Ingelheim Investigational Site
  • 1218.43.10025 Boehringer Ingelheim Investigational Site
  • 1218.43.10023 Boehringer Ingelheim Investigational Site
  • 1218.43.10024 Boehringer Ingelheim Investigational Site
  • 1218.43.10014 Boehringer Ingelheim Investigational Site
  • 1218.43.10017 Boehringer Ingelheim Investigational Site
  • 1218.43.10010 Boehringer Ingelheim Investigational Site
  • 1218.43.61009 Boehringer Ingelheim Investigational Site
  • 1218.43.61010 Boehringer Ingelheim Investigational Site
  • 1218.43.61006 Boehringer Ingelheim Investigational Site
  • 1218.43.61007 Boehringer Ingelheim Investigational Site
  • 1218.43.61011 Boehringer Ingelheim Investigational Site
  • 1218.43.61005 Boehringer Ingelheim Investigational Site
  • 1218.43.61002 Boehringer Ingelheim Investigational Site
  • 1218.43.85201 Boehringer Ingelheim Investigational Site
  • 1218.43.85203 Boehringer Ingelheim Investigational Site
  • 1218.43.97008 Boehringer Ingelheim Investigational Site
  • 1218.43.97005 Boehringer Ingelheim Investigational Site
  • 1218.43.97003 Boehringer Ingelheim Investigational Site
  • 1218.43.97004 Boehringer Ingelheim Investigational Site
  • 1218.43.97009 Boehringer Ingelheim Investigational Site
  • 1218.43.97002 Boehringer Ingelheim Investigational Site
  • 1218.43.97007 Boehringer Ingelheim Investigational Site
  • 1218.43.97001 Boehringer Ingelheim Investigational Site
  • 1218.43.97006 Boehringer Ingelheim Investigational Site
  • 1218.43.64001 Boehringer Ingelheim Investigational Site
  • 1218.43.64003 Boehringer Ingelheim Investigational Site
  • 1218.43.64004 Boehringer Ingelheim Investigational Site
  • 1218.43.64002 Boehringer Ingelheim Investigational Site
  • 1218.43.38004 Boehringer Ingelheim Investigational Site
  • 1218.43.38003 Boehringer Ingelheim Investigational Site
  • 1218.43.38006 Boehringer Ingelheim Investigational Site
  • 1218.43.38005 Boehringer Ingelheim Investigational Site
  • 1218.43.38007 Boehringer Ingelheim Investigational Site
  • 1218.43.38008 Boehringer Ingelheim Investigational Site
  • 1218.43.38002 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BI 1356

placebo

Arm Description

patient to receive a tablet containing BI 1356 once daily

patient to receive a tablet identical to BI 1356 once daily

Outcomes

Primary Outcome Measures

HbA1c Change From Baseline at Week 12
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.

Secondary Outcome Measures

HbA1c Change From Baseline at Week 52
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 18
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 24
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 30
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 36
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 42
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 48
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
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 continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 18
Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
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 continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 30
This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 36
This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 42
This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 48
This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at week52
This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.

Full Information

First Posted
December 1, 2008
Last Updated
May 15, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00800683
Brief Title
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
Official Title
Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2011 (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
to determine safety, efficacy and tolerability of BI 1356 versus placebo

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
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 1356
Arm Type
Experimental
Arm Description
patient to receive a tablet containing BI 1356 once daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
patient to receive a tablet identical to BI 1356 once daily
Intervention Type
Drug
Intervention Name(s)
BI 1356
Intervention Description
BI 1356 dosed once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo matching BI 1356 taken once daily
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline at Week 12
Description
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
HbA1c Change From Baseline at Week 52
Description
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time Frame
Baseline and Week 52
Title
HbA1c Change From Baseline at Week 18
Description
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time Frame
Baseline and Week 18
Title
HbA1c Change From Baseline at Week 24
Description
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time Frame
Baseline and Week 24
Title
HbA1c Change From Baseline at Week 30
Description
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time Frame
Baseline and Week 30
Title
HbA1c Change From Baseline at Week 36
Description
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time Frame
Baseline and Week 36
Title
HbA1c Change From Baseline at Week 42
Description
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time Frame
Baseline and Week 42
Title
HbA1c Change From Baseline at Week 48
Description
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time Frame
Baseline and Week 48
Title
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
Description
The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
Time Frame
Baseline and Week 52
Title
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
Description
The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.
Time Frame
Baseline and Week 52
Title
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
Description
The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
Time Frame
Baseline and Week 52
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 continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Time Frame
Baseline and Week 12
Title
FPG Change From Baseline at Week 18
Description
Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
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 continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time Frame
Baseline and Week 24
Title
FPG Change From Baseline at Week 30
Description
This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time Frame
Baseline and Week 30
Title
FPG Change From Baseline at Week 36
Description
This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time Frame
Baseline and Week 36
Title
FPG Change From Baseline at Week 42
Description
This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time Frame
Baseline and Week 42
Title
FPG Change From Baseline at Week 48
Description
This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time Frame
Baseline and Week 48
Title
FPG Change From Baseline at week52
Description
This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time Frame
Baseline and Week 52
Title
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Description
Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Time Frame
Baseline and Week 52
Title
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Description
Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Time Frame
first administration of randomised treatment to ....

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 type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis. Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%) Age 18 or over and not older than 80 years Exclusion criteria: Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent Unstable or acute congestive heart failure
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
1218.43.10027 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
1218.43.10011 Boehringer Ingelheim Investigational Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
1218.43.10006 Boehringer Ingelheim Investigational Site
City
Riverside
State/Province
California
Country
United States
Facility Name
1218.43.10021 Boehringer Ingelheim Investigational Site
City
Whittier
State/Province
California
Country
United States
Facility Name
1218.43.10013 Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
1218.43.10009 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
1218.43.10018 Boehringer Ingelheim Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
1218.43.10022 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1218.43.10015 Boehringer Ingelheim Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
1218.43.10016 Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
1218.43.10004 Boehringer Ingelheim Investigational Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
1218.43.10003 Boehringer Ingelheim Investigational Site
City
Great Neck
State/Province
New York
Country
United States
Facility Name
1218.43.10020 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
1218.43.10019 Boehringer Ingelheim Investigational Site
City
Delaware
State/Province
Ohio
Country
United States
Facility Name
1218.43.10008 Boehringer Ingelheim Investigational Site
City
Mentor
State/Province
Ohio
Country
United States
Facility Name
1218.43.10005 Boehringer Ingelheim Investigational Site
City
Bethlehem
State/Province
Pennsylvania
Country
United States
Facility Name
1218.43.10007 Boehringer Ingelheim Investigational Site
City
Carlisle
State/Province
Pennsylvania
Country
United States
Facility Name
1218.43.10001 Boehringer Ingelheim Investigational Site
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
1218.43.10025 Boehringer Ingelheim Investigational Site
City
Aiken
State/Province
South Carolina
Country
United States
Facility Name
1218.43.10023 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1218.43.10024 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1218.43.10014 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1218.43.10017 Boehringer Ingelheim Investigational Site
City
Lufkin
State/Province
Texas
Country
United States
Facility Name
1218.43.10010 Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
1218.43.61009 Boehringer Ingelheim Investigational Site
City
Gosford
State/Province
New South Wales
Country
Australia
Facility Name
1218.43.61010 Boehringer Ingelheim Investigational Site
City
Auchenflower
State/Province
Queensland
Country
Australia
Facility Name
1218.43.61006 Boehringer Ingelheim Investigational Site
City
Kippa Ring
State/Province
Queensland
Country
Australia
Facility Name
1218.43.61007 Boehringer Ingelheim Investigational Site
City
Reservoir
State/Province
Victoria
Country
Australia
Facility Name
1218.43.61011 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Victoria
Country
Australia
Facility Name
1218.43.61005 Boehringer Ingelheim Investigational Site
City
Adelaide, SA
Country
Australia
Facility Name
1218.43.61002 Boehringer Ingelheim Investigational Site
City
Herston, QLD
Country
Australia
Facility Name
1218.43.85201 Boehringer Ingelheim Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
1218.43.85203 Boehringer Ingelheim Investigational Site
City
New Territories
Country
Hong Kong
Facility Name
1218.43.97008 Boehringer Ingelheim Investigational Site
City
Afula
Country
Israel
Facility Name
1218.43.97005 Boehringer Ingelheim Investigational Site
City
Ashkelon
Country
Israel
Facility Name
1218.43.97003 Boehringer Ingelheim Investigational Site
City
Haifa
Country
Israel
Facility Name
1218.43.97004 Boehringer Ingelheim Investigational Site
City
Jerusalem
Country
Israel
Facility Name
1218.43.97009 Boehringer Ingelheim Investigational Site
City
Jerusalem
Country
Israel
Facility Name
1218.43.97002 Boehringer Ingelheim Investigational Site
City
Kfar Saba
Country
Israel
Facility Name
1218.43.97007 Boehringer Ingelheim Investigational Site
City
Nahariya
Country
Israel
Facility Name
1218.43.97001 Boehringer Ingelheim Investigational Site
City
Safed
Country
Israel
Facility Name
1218.43.97006 Boehringer Ingelheim Investigational Site
City
Tel Aviv
Country
Israel
Facility Name
1218.43.64001 Boehringer Ingelheim Investigational Site
City
Auckland
Country
New Zealand
Facility Name
1218.43.64003 Boehringer Ingelheim Investigational Site
City
Christchurch
Country
New Zealand
Facility Name
1218.43.64004 Boehringer Ingelheim Investigational Site
City
Takpuna
Country
New Zealand
Facility Name
1218.43.64002 Boehringer Ingelheim Investigational Site
City
Tauranga
Country
New Zealand
Facility Name
1218.43.38004 Boehringer Ingelheim Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
1218.43.38003 Boehringer Ingelheim Investigational Site
City
Kharkov
Country
Ukraine
Facility Name
1218.43.38006 Boehringer Ingelheim Investigational Site
City
Kharkov
Country
Ukraine
Facility Name
1218.43.38005 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1218.43.38007 Boehringer Ingelheim Investigational Site
City
Lugansk
Country
Ukraine
Facility Name
1218.43.38008 Boehringer Ingelheim Investigational Site
City
Ternopil
Country
Ukraine
Facility Name
1218.43.38002 Boehringer Ingelheim Investigational Site
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
24169807
Citation
McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.43_U11-3170.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.43_Literature.pdf
Description
Related Info

Learn more about this trial

Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

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