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

December 11, 2013 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

701

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

  • Czech Republic
      • Breclav, Czech Republic
        • 1218.17.42006 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1218.17.42001 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1218.17.42004 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1218.17.42007 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1218.17.42009 Boehringer Ingelheim Investigational Site
      • Hodonin, Czech Republic
        • 1218.17.42008 Boehringer Ingelheim Investigational Site
      • Olomouc, Czech Republic
        • 1218.17.42003 Boehringer Ingelheim Investigational Site
  • Finland
      • Helsinki, Finland
        • 1218.17.35806 Boehringer Ingelheim Investigational Site
      • Jyväskylä, Finland
        • 1218.17.35804 Boehringer Ingelheim Investigational Site
      • Kuopio, Finland
        • 1218.17.35801 Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • 1218.17.35803 Boehringer Ingelheim Investigational Site
      • Seinäjoki, Finland
        • 1218.17.35805 Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • 1218.17.35802 Boehringer Ingelheim Investigational Site
  • Greece
      • Athens, Greece
        • 1218.17.30004 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 1218.17.30013 Boehringer Ingelheim Investigational Site
      • Piraeus, Greece
        • 1218.17.30011 Boehringer Ingelheim Investigational Site
  • India
      • Andhra Pradesh, India
        • 1218.17.91009 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.17.91002 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.17.91005 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1218.17.91012 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1218.17.91014 Boehringer Ingelheim Investigational Site
      • Hyderabad, India
        • 1218.17.91010 Boehringer Ingelheim Investigational Site
      • Jaipur, India
        • 1218.17.91006 Boehringer Ingelheim Investigational Site
      • Karnataka, India
        • 1218.17.91007 Boehringer Ingelheim Investigational Site
      • Mangalore, India
        • 1218.17.91008 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 1218.17.91004 Boehringer Ingelheim Investigational Site
      • Nagpur, India
        • 1218.17.91011 Boehringer Ingelheim Investigational Site
      • Nasik, India
        • 1218.17.91003 Boehringer Ingelheim Investigational Site
      • Trivandrum, India
        • 1218.17.91001 Boehringer Ingelheim Investigational Site
      • Uttar Pradesh, India
        • 1218.17.91013 Boehringer Ingelheim Investigational Site
  • Israel
      • Afula, Israel
        • 1218.17.97274 Boehringer Ingelheim Investigational Site
      • Haifa, Israel
        • 1218.17.97273 Boehringer Ingelheim Investigational Site
      • Holon, Israel
        • 1218.17.97275 Boehringer Ingelheim Investigational Site
      • Jerusalem, Israel
        • 1218.17.97271 Boehringer Ingelheim Investigational Site
      • Nahariya, Israel
        • 1218.17.97272 Boehringer Ingelheim Investigational Site
      • Safed, Israel
        • 1218.17.97276 Boehringer Ingelheim Investigational Site
      • Tel Aviv, Israel
        • 1218.17.97278 Boehringer Ingelheim Investigational Site
  • Mexico
      • Aguascalientes, Ags., Mexico
        • 1218.17.52007 Boehringer Ingelheim Investigational Site
      • Col. Lomas de San Francisco, Monterrey, Mexico
        • 1218.17.52003 Boehringer Ingelheim Investigational Site
      • Col. Mitras Centro, Monterrey, N.L., Mexico
        • 1218.17.52001 Boehringer Ingelheim Investigational Site
      • Col.Americana, Guadalajara, Jalisco, Mexico
        • 1218.17.52010 Boehringer Ingelheim Investigational Site
      • Colonia Reforma Social, Mexico
        • 1218.17.52005 Boehringer Ingelheim Investigational Site
      • Colonia Tlalpan, mexico, Mexico
        • 1218.17.52008 Boehringer Ingelheim Investigational Site
      • Faccionamiento Lomas de Campestre,AGUASCAL, Mexico
        • 1218.17.52006 Boehringer Ingelheim Investigational Site
      • Mexico, Mexico
        • 1218.17.52002 Boehringer Ingelheim Investigational Site
      • Tlalpan-México D,F, Mexico
        • 1218.17.52004 Boehringer Ingelheim Investigational Site
      • cOL OBREGON,León, Guanajuato, Mexico
        • 1218.17.52009 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Christchurch, New Zealand
        • 1218.17.64004 Boehringer Ingelheim Investigational Site
      • Dunedin, New Zealand
        • 1218.17.64003 Boehringer Ingelheim Investigational Site
      • Otahuhu, New Zealand
        • 1218.17.64002 Boehringer Ingelheim Investigational Site
      • Tauranga, New Zealand
        • 1218.17.64001 Boehringer Ingelheim Investigational Site
      • Wellington, New Zealand
        • 1218.17.64005 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1218.17.70001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.17.70002 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.17.70003 Boehringer Ingelheim Investigational Site
      • Novosibirsk, Russian Federation
        • 1218.17.70005 Boehringer Ingelheim Investigational Site
      • Perm, Russian Federation
        • 1218.17.70006 Boehringer Ingelheim Investigational Site
      • Tomsk, Russian Federation
        • 1218.17.70004 Boehringer Ingelheim Investigational Site
  • Sweden
      • Härnösand, Sweden
        • 1218.17.46013 Boehringer Ingelheim Investigational Site
      • Malmö, Sweden
        • 1218.17.46001 Boehringer Ingelheim Investigational Site
      • Uddevalla, Sweden
        • 1218.17.46012 Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden
        • 1218.17.46004 Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden
        • 1218.17.46015 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • Chula Vista, California, United States
        • 1218.17.10003 Boehringer Ingelheim Investigational Site
      • Spring Valley, California, United States
        • 1218.17.10014 Boehringer Ingelheim Investigational Site
      • Walnut Creek, California, United States
        • 1218.17.10001 Boehringer Ingelheim Investigational Site
    • Colorado
      • Northglenn, Colorado, United States
        • 1218.17.10021 Boehringer Ingelheim Investigational Site
    • Florida
      • Hollywood, Florida, United States
        • 1218.17.10010 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1218.17.10011 Boehringer Ingelheim Investigational Site
      • Pembroke Pines, Florida, United States
        • 1218.17.10008 Boehringer Ingelheim Investigational Site
    • Illinois
      • Gurnee, Illinois, United States
        • 1218.17.10017 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 1218.17.10006 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • 1218.17.10012 Boehringer Ingelheim Investigational Site
    • Ohio
      • Mentor, Ohio, United States
        • 1218.17.10013 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 1218.17.10015 Boehringer Ingelheim Investigational Site
    • Oregon
      • Eugene, Oregon, United States
        • 1218.17.10016 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greer, South Carolina, United States
        • 1218.17.10002 Boehringer Ingelheim Investigational Site
      • Simpsonville, South Carolina, United States
        • 1218.17.10004 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1218.17.10005 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1218.17.10018 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1218.17.10007 Boehringer Ingelheim Investigational Site
    • Washington
      • Federal Way, Washington, United States
        • 1218.17.10009 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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Patients receive linagliptin 5 mg tablets once daily
Drug: linagliptin
Patients receive linagliptin 5 mg tablets once daily
PLACEBO_COMPARATOR: Placebo
Patients receive placebo tablets matching linagliptin 5 mg tablets once daily
Drug: linagliptin
Patients receive linagliptin 5 mg tablets once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline at Week 24
Time Frame: Baseline and 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.
Baseline and week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline at Week 6
Time Frame: Baseline and 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.
Baseline and week 6
HbA1c Change From Baseline at 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 and previous anti-diabetic medication.
Baseline and week 12
HbA1c Change From Baseline at Week 18
Time Frame: Baseline and 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.
Baseline and week 18
FPG Change From Baseline at Week 24
Time Frame: Baseline and 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.
Baseline and week 24
FPG Change From Baseline at Week 6
Time Frame: Baseline and 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.
Baseline and week 6
FPG Change From Baseline at 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 previous anti-diabetic medication.
Baseline and week 12
FPG Change From Baseline at Week 18
Time Frame: Baseline and 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.
Baseline and week 18
Percentage of Patients With HbA1c<6.5% at Week 24
Time Frame: Baseline and 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%.
Baseline and week 24
Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24
Time Frame: Baseline and 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.
Baseline and week 24
Percentage of Patients With HbA1c <7.0% at Week 24.
Time Frame: Baseline and 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%
Baseline and week 24
Percentage of Patients With HbA1c < 7.0% at Week 24
Time Frame: Baseline and 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%.
Baseline and week 24
Percentage of Patients With HbA1c <6.5% at Week 24
Time Frame: Baseline and 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%
Baseline and week 24
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24
Time Frame: Baseline and 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%.
Baseline and week 24
2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24
Time Frame: Baseline and 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.
Baseline and week 24

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

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.

General Publications

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

January 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (ESTIMATE)

January 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2014

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.17
  • 2007-002457-24 (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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