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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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