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Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glimepiride
Placebo
Placebo
Placebo
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Type 2 diabetes mellitus
  2. GFR<60 ml/min
  3. HbA1c >=7.0% to <= 10%
  4. Age >= 18 years
  5. BMI <=45 kg/m2
  6. Signed and dated written informed consent

Exclusion criteria:

  1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
  2. Renal impairment requiring dialysis
  3. Bariatric surgery
  4. Impaired hepatic function
  5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors
  6. Treatment with anti-obesity drugs
  7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent

Sites / Locations

  • 1218.64.10007 Boehringer Ingelheim Investigational Site
  • 1218.64.10018 Boehringer Ingelheim Investigational Site
  • 1218.64.10016 Boehringer Ingelheim Investigational Site
  • 1218.64.10015 Boehringer Ingelheim Investigational Site
  • 1218.64.10002 Boehringer Ingelheim Investigational Site
  • 1218.64.10004 Boehringer Ingelheim Investigational Site
  • 1218.64.10006 Boehringer Ingelheim Investigational Site
  • 1218.64.10003 Boehringer Ingelheim Investigational Site
  • 1218.64.10013 Boehringer Ingelheim Investigational Site
  • 1218.64.10020 Boehringer Ingelheim Investigational Site
  • 1218.64.10008 Boehringer Ingelheim Investigational Site
  • 1218.64.10009 Boehringer Ingelheim Investigational Site
  • 1218.64.10005 Boehringer Ingelheim Investigational Site
  • 1218.64.10011 Boehringer Ingelheim Investigational Site
  • 1218.64.10014 Boehringer Ingelheim Investigational Site
  • 1218.64.10010 Boehringer Ingelheim Investigational Site
  • 1218.64.61005 Boehringer Ingelheim Investigational Site
  • 1218.64.61001 Boehringer Ingelheim Investigational Site
  • 1218.64.61002 Boehringer Ingelheim Investigational Site
  • 1218.64.61003 Boehringer Ingelheim Investigational Site
  • 1218.64.61004 Boehringer Ingelheim Investigational Site
  • 1218.64.20008 Boehringer Ingelheim Investigational Site
  • 1218.64.20005 Boehringer Ingelheim Investigational Site
  • 1218.64.20007 Boehringer Ingelheim Investigational Site
  • 1218.64.20002 Boehringer Ingelheim Investigational Site
  • 1218.64.20009 Boehringer Ingelheim Investigational Site
  • 1218.64.20004 Boehringer Ingelheim Investigational Site
  • 1218.64.20003 Boehringer Ingelheim Investigational Site
  • 1218.64.35804 Boehringer Ingelheim Investigational Site
  • 1218.64.35803 Boehringer Ingelheim Investigational Site
  • 1218.64.35801 Boehringer Ingelheim Investigational Site
  • 1218.64.97204 Boehringer Ingelheim Investigational Site
  • 1218.64.97207 Boehringer Ingelheim Investigational Site
  • 1218.64.97203 Boehringer Ingelheim Investigational Site
  • 1218.64.97201 Boehringer Ingelheim Investigational Site
  • 1218.64.97202 Boehringer Ingelheim Investigational Site
  • 1218.64.97206 Boehringer Ingelheim Investigational Site
  • 1218.64.81005 Boehringer Ingelheim Investigational Site
  • 1218.64.81006 Boehringer Ingelheim Investigational Site
  • 1218.64.81001 Boehringer Ingelheim Investigational Site
  • 1218.64.81008 Boehringer Ingelheim Investigational Site
  • 1218.64.81007 Boehringer Ingelheim Investigational Site
  • 1218.64.81002 Boehringer Ingelheim Investigational Site
  • 1218.64.81004 Boehringer Ingelheim Investigational Site
  • 1218.64.81003 Boehringer Ingelheim Investigational Site
  • 1218.64.64001 Boehringer Ingelheim Investigational Site
  • 1218.64.42102 Boehringer Ingelheim Investigational Site
  • 1218.64.42107 Boehringer Ingelheim Investigational Site
  • 1218.64.42109 Boehringer Ingelheim Investigational Site
  • 1218.64.42108 Boehringer Ingelheim Investigational Site
  • 1218.64.46003 Boehringer Ingelheim Investigational Site
  • 1218.64.46002 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Linagliptin

Placebo

Glimepiride

Arm Description

52 weeks treatment

First 12 weeks of treatment

Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)

Outcomes

Primary Outcome Measures

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, renal function impairment and prior use of antidiabetic agents.

Secondary Outcome Measures

HbA1c Change From Baseline Over Time
HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.
Fasting Plasma Glucose (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 prior use of insulin, week repeated within patient and week by treatment interaction.
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.
Percentage of Patients With HbA1c <7.0%
The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.
Percentage of Patients With HbA1c <6.5%
The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%
The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.
Plasma Concentration of Linagliptin at Trough
Trough levels of concentration of Linagliptin in plasma.

Full Information

First Posted
March 15, 2010
Last Updated
June 17, 2014
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01087502
Brief Title
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
Official Title
A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).

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
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Linagliptin
Arm Type
Experimental
Arm Description
52 weeks treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
First 12 weeks of treatment
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Intervention Description
1-4 mg daily after 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo mach to 5 mg linagliptin once daily after 12 weeks
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Intervention Description
5 mg once daily
Primary Outcome Measure Information:
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, renal function impairment and prior use of antidiabetic agents.
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
HbA1c Change From Baseline Over Time
Description
HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.
Time Frame
Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Title
Fasting Plasma Glucose (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 prior use of insulin, week repeated within patient and week by treatment interaction.
Time Frame
Baseline and week 12
Title
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Description
This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.
Time Frame
Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Title
Percentage of Patients With HbA1c <7.0%
Description
The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.
Time Frame
Baseline, week 12 and week 52
Title
Percentage of Patients With HbA1c <6.5%
Description
The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.
Time Frame
Baseline, week 12 and week 52
Title
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%
Description
The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.
Time Frame
Baseline, week 12 and week 52
Title
Plasma Concentration of Linagliptin at Trough
Description
Trough levels of concentration of Linagliptin in plasma.
Time Frame
Week 12, 24 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Type 2 diabetes mellitus GFR<60 ml/min HbA1c >=7.0% to <= 10% Age >= 18 years BMI <=45 kg/m2 Signed and dated written informed consent Exclusion criteria: Myocardial infarction, stroke or TIA within 3 months prior to informed consent Renal impairment requiring dialysis Bariatric surgery Impaired hepatic function Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors Treatment with anti-obesity drugs Treatment with SU, glinides and metformin 8 weeks prior to informed consent
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
1218.64.10007 Boehringer Ingelheim Investigational Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
1218.64.10018 Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
1218.64.10016 Boehringer Ingelheim Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
1218.64.10015 Boehringer Ingelheim Investigational Site
City
Boise
State/Province
Idaho
Country
United States
Facility Name
1218.64.10002 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1218.64.10004 Boehringer Ingelheim Investigational Site
City
Flint
State/Province
Michigan
Country
United States
Facility Name
1218.64.10006 Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
1218.64.10003 Boehringer Ingelheim Investigational Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
1218.64.10013 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1218.64.10020 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1218.64.10008 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
1218.64.10009 Boehringer Ingelheim Investigational Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
1218.64.10005 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1218.64.10011 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1218.64.10014 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1218.64.10010 Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
1218.64.61005 Boehringer Ingelheim Investigational Site
City
Gosford
State/Province
New South Wales
Country
Australia
Facility Name
1218.64.61001 Boehringer Ingelheim Investigational Site
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
1218.64.61002 Boehringer Ingelheim Investigational Site
City
St Leonards
State/Province
New South Wales
Country
Australia
Facility Name
1218.64.61003 Boehringer Ingelheim Investigational Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
1218.64.61004 Boehringer Ingelheim Investigational Site
City
Reservoir
State/Province
Victoria
Country
Australia
Facility Name
1218.64.20008 Boehringer Ingelheim Investigational Site
City
Corunna
State/Province
Ontario
Country
Canada
Facility Name
1218.64.20005 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1218.64.20007 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1218.64.20002 Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
1218.64.20009 Boehringer Ingelheim Investigational Site
City
Stayner
State/Province
Ontario
Country
Canada
Facility Name
1218.64.20004 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1218.64.20003 Boehringer Ingelheim Investigational Site
City
Point Claire
State/Province
Quebec
Country
Canada
Facility Name
1218.64.35804 Boehringer Ingelheim Investigational Site
City
Kokkola
Country
Finland
Facility Name
1218.64.35803 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
1218.64.35801 Boehringer Ingelheim Investigational Site
City
Turku
Country
Finland
Facility Name
1218.64.97204 Boehringer Ingelheim Investigational Site
City
Ashkelon
Country
Israel
Facility Name
1218.64.97207 Boehringer Ingelheim Investigational Site
City
Givatayim
Country
Israel
Facility Name
1218.64.97203 Boehringer Ingelheim Investigational Site
City
Haifa
Country
Israel
Facility Name
1218.64.97201 Boehringer Ingelheim Investigational Site
City
Jerusalem
Country
Israel
Facility Name
1218.64.97202 Boehringer Ingelheim Investigational Site
City
Nahariya
Country
Israel
Facility Name
1218.64.97206 Boehringer Ingelheim Investigational Site
City
Tel Aviv
Country
Israel
Facility Name
1218.64.81005 Boehringer Ingelheim Investigational Site
City
Asahi, Chiba
Country
Japan
Facility Name
1218.64.81006 Boehringer Ingelheim Investigational Site
City
Isesaki, Gunma
Country
Japan
Facility Name
1218.64.81001 Boehringer Ingelheim Investigational Site
City
Meguro-ku, Tokyo
Country
Japan
Facility Name
1218.64.81008 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1218.64.81007 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1218.64.81002 Boehringer Ingelheim Investigational Site
City
Shinjyuku-ku,Tokyo
Country
Japan
Facility Name
1218.64.81004 Boehringer Ingelheim Investigational Site
City
Suita, Osaka
Country
Japan
Facility Name
1218.64.81003 Boehringer Ingelheim Investigational Site
City
Suwa, Nagano
Country
Japan
Facility Name
1218.64.64001 Boehringer Ingelheim Investigational Site
City
Otahuhu Auckland
Country
New Zealand
Facility Name
1218.64.42102 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
1218.64.42107 Boehringer Ingelheim Investigational Site
City
Kosice
Country
Slovakia
Facility Name
1218.64.42109 Boehringer Ingelheim Investigational Site
City
Nitra
Country
Slovakia
Facility Name
1218.64.42108 Boehringer Ingelheim Investigational Site
City
Trencin
Country
Slovakia
Facility Name
1218.64.46003 Boehringer Ingelheim Investigational Site
City
Helsingborg
Country
Sweden
Facility Name
1218.64.46002 Boehringer Ingelheim Investigational Site
City
Härnösand
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.64_U13-1283-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.64_Literature.pdf
Description
Related Info

Learn more about this trial

Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

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