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

June 17, 2014 updated by: Boehringer Ingelheim

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia
        • 1218.64.61005 Boehringer Ingelheim Investigational Site
      • Liverpool, New South Wales, Australia
        • 1218.64.61001 Boehringer Ingelheim Investigational Site
      • St Leonards, New South Wales, Australia
        • 1218.64.61002 Boehringer Ingelheim Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia
        • 1218.64.61003 Boehringer Ingelheim Investigational Site
    • Victoria
      • Reservoir, Victoria, Australia
        • 1218.64.61004 Boehringer Ingelheim Investigational Site
  • Canada
    • Ontario
      • Corunna, Ontario, Canada
        • 1218.64.20008 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1218.64.20005 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1218.64.20007 Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada
        • 1218.64.20002 Boehringer Ingelheim Investigational Site
      • Stayner, Ontario, Canada
        • 1218.64.20009 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1218.64.20004 Boehringer Ingelheim Investigational Site
    • Quebec
      • Point Claire, Quebec, Canada
        • 1218.64.20003 Boehringer Ingelheim Investigational Site
  • Finland
      • Kokkola, Finland
        • 1218.64.35804 Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • 1218.64.35803 Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • 1218.64.35801 Boehringer Ingelheim Investigational Site
  • Israel
      • Ashkelon, Israel
        • 1218.64.97204 Boehringer Ingelheim Investigational Site
      • Givatayim, Israel
        • 1218.64.97207 Boehringer Ingelheim Investigational Site
      • Haifa, Israel
        • 1218.64.97203 Boehringer Ingelheim Investigational Site
      • Jerusalem, Israel
        • 1218.64.97201 Boehringer Ingelheim Investigational Site
      • Nahariya, Israel
        • 1218.64.97202 Boehringer Ingelheim Investigational Site
      • Tel Aviv, Israel
        • 1218.64.97206 Boehringer Ingelheim Investigational Site
  • Japan
      • Asahi, Chiba, Japan
        • 1218.64.81005 Boehringer Ingelheim Investigational Site
      • Isesaki, Gunma, Japan
        • 1218.64.81006 Boehringer Ingelheim Investigational Site
      • Meguro-ku, Tokyo, Japan
        • 1218.64.81001 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.64.81008 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1218.64.81007 Boehringer Ingelheim Investigational Site
      • Shinjyuku-ku,Tokyo, Japan
        • 1218.64.81002 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japan
        • 1218.64.81004 Boehringer Ingelheim Investigational Site
      • Suwa, Nagano, Japan
        • 1218.64.81003 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Otahuhu Auckland, New Zealand
        • 1218.64.64001 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Bratislava, Slovakia
        • 1218.64.42102 Boehringer Ingelheim Investigational Site
      • Kosice, Slovakia
        • 1218.64.42107 Boehringer Ingelheim Investigational Site
      • Nitra, Slovakia
        • 1218.64.42109 Boehringer Ingelheim Investigational Site
      • Trencin, Slovakia
        • 1218.64.42108 Boehringer Ingelheim Investigational Site
  • Sweden
      • Helsingborg, Sweden
        • 1218.64.46003 Boehringer Ingelheim Investigational Site
      • Härnösand, Sweden
        • 1218.64.46002 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • Chula Vista, California, United States
        • 1218.64.10007 Boehringer Ingelheim Investigational Site
    • Florida
      • Pembroke Pines, Florida, United States
        • 1218.64.10018 Boehringer Ingelheim Investigational Site
    • Georgia
      • Decatur, Georgia, United States
        • 1218.64.10016 Boehringer Ingelheim Investigational Site
    • Idaho
      • Boise, Idaho, United States
        • 1218.64.10015 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1218.64.10002 Boehringer Ingelheim Investigational Site
    • Michigan
      • Flint, Michigan, United States
        • 1218.64.10004 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City, Missouri, United States
        • 1218.64.10006 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, United States
        • 1218.64.10003 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1218.64.10013 Boehringer Ingelheim Investigational Site
      • Philadelphia, Pennsylvania, United States
        • 1218.64.10020 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, United States
        • 1218.64.10008 Boehringer Ingelheim Investigational Site
    • Texas
      • Arlington, Texas, United States
        • 1218.64.10009 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1218.64.10005 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1218.64.10011 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1218.64.10014 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, United States
        • 1218.64.10010 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Linagliptin
52 weeks treatment
Drug: Placebo
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily
Drug: Placebo
Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment
Drug: Placebo
Placebo mach to 5 mg linagliptin once daily after 12 weeks
Drug: Linagliptin
5 mg once daily
PLACEBO_COMPARATOR: Placebo
First 12 weeks of treatment
Drug: Placebo
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily
Drug: Placebo
Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment
Drug: Placebo
Placebo mach to 5 mg linagliptin once daily after 12 weeks
ACTIVE_COMPARATOR: Glimepiride
Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
Drug: Placebo
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily
Drug: Placebo
Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment
Drug: Placebo
Placebo mach to 5 mg linagliptin once daily after 12 weeks
Drug: Glimepiride
1-4 mg daily after 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline to Week 12
Time Frame: Baseline and 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.
Baseline and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline Over Time
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
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.
Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Fasting Plasma Glucose (FPG) Change From Baseline to Week 12
Time Frame: Baseline and 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.
Baseline and week 12
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Time Frame: Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52
This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.
Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52
Percentage of Patients With HbA1c <7.0%
Time Frame: Baseline, week 12 and week 52
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%.
Baseline, week 12 and week 52
Percentage of Patients With HbA1c <6.5%
Time Frame: Baseline, week 12 and week 52
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%.
Baseline, week 12 and week 52
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%
Time Frame: Baseline, week 12 and week 52
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%.
Baseline, week 12 and week 52
Plasma Concentration of Linagliptin at Trough
Time Frame: Week 12, 24 and 52
Trough levels of concentration of Linagliptin in plasma.
Week 12, 24 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (ESTIMATE)

March 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.64
  • 2009-016971-31 (EUDRACT_NUMBER: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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