Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

June 17, 2014 updated by: Boehringer Ingelheim

12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

491

Phase

  • Phase 2

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

  • Belgium
      • De Pinte, Belgium
        • 1218.62.32003 Boehringer Ingelheim Investigational Site
      • Kortenaken, Belgium
        • 1218.62.32008 Boehringer Ingelheim Investigational Site
      • Kumtich, Belgium
        • 1218.62.32009 Boehringer Ingelheim Investigational Site
      • Massemen-Wetteren, Belgium
        • 1218.62.32005 Boehringer Ingelheim Investigational Site
      • Natoye, Belgium
        • 1218.62.32004 Boehringer Ingelheim Investigational Site
      • Sint-Job-in't-Goor, Belgium
        • 1218.62.32007 Boehringer Ingelheim Investigational Site
      • Tessenderlo, Belgium
        • 1218.62.32002 Boehringer Ingelheim Investigational Site
      • Wilsele, Belgium
        • 1218.62.32006 Boehringer Ingelheim Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 1218.62.11012 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Burnaby, British Columbia, Canada
        • 1218.62.11007 Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • 1218.62.11011 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 1218.62.11006 Boehringer Ingelheim Investigational Site
    • Ontario
      • Barrie, Ontario, Canada
        • 1218.62.11001 Boehringer Ingelheim Investigational Site
      • Brampton, Ontario, Canada
        • 1218.62.11003 Boehringer Ingelheim Investigational Site
      • Markham, Ontario, Canada
        • 1218.62.11004 Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada
        • 1218.62.11005 Boehringer Ingelheim Investigational Site
      • Smiths Falls, Ontario, Canada
        • 1218.62.11008 Boehringer Ingelheim Investigational Site
      • Strathroy, Ontario, Canada
        • 1218.62.11013 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1218.62.11014 Boehringer Ingelheim Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
        • 1218.62.11010 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1218.62.11002 Boehringer Ingelheim Investigational Site
      • Point Claire, Quebec, Canada
        • 1218.62.11009 Boehringer Ingelheim Investigational Site
  • France
      • Bort les Orgues, France
        • 1218.62.3303C Boehringer Ingelheim Investigational Site
      • Bourg des cptes, France
        • 1218.62.3306A Boehringer Ingelheim Investigational Site
      • Bugeat, France
        • 1218.62.3303D Boehringer Ingelheim Investigational Site
      • Corsept, France
        • 1218.62.3302H Boehringer Ingelheim Investigational Site
      • Derval, France
        • 1218.62.3308A Boehringer Ingelheim Investigational Site
      • La Chapelle sur Erdre, France
        • 1218.62.3302B Boehringer Ingelheim Investigational Site
      • Levallois Perret, France
        • 1218.62.3304A Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1218.62.3305A Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1218.62.3305B Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1218.62.3305G Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1218.62.3305H Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1218.62.3302A Boehringer Ingelheim Investigational Site
      • Nantes Cedex 1, France
        • 1218.62.3301A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1218.62.3304B Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1218.62.3304D Boehringer Ingelheim Investigational Site
      • Roquevaire, France
        • 1218.62.3305F Boehringer Ingelheim Investigational Site
      • Roquevaire, France
        • 1218.62.3305I Boehringer Ingelheim Investigational Site
      • Rosiers d'Egletons, France
        • 1218.62.3303A Boehringer Ingelheim Investigational Site
      • Sainte Fortunade, France
        • 1218.62.3303H Boehringer Ingelheim Investigational Site
      • Sautron, France
        • 1218.62.3302I Boehringer Ingelheim Investigational Site
      • VUE, France
        • 1218.62.3302G Boehringer Ingelheim Investigational Site
  • India
      • Bangalore, India
        • 1218.62.91001 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.62.91004 Boehringer Ingelheim Investigational Site
      • Hyderabad, Andra Pradesh, India
        • 1218.62.91003 Boehringer Ingelheim Investigational Site
      • Nagpru, India
        • 1218.62.91005 Boehringer Ingelheim Investigational Site
      • Trivandrum, India
        • 1218.62.91002 Boehringer Ingelheim Investigational Site
  • Italy
      • Ancona, Italy
        • 1218.62.39010 Boehringer Ingelheim Investigational Site
      • Catania, Italy
        • 1218.62.39006 Boehringer Ingelheim Investigational Site
      • Genova, Italy
        • 1218.62.39004 Boehringer Ingelheim Investigational Site
      • Gissi (CH), Italy
        • 1218.62.39009 Boehringer Ingelheim Investigational Site
      • Palermo, Italy
        • 1218.62.39003 Boehringer Ingelheim Investigational Site
      • Pisa, Italy
        • 1218.62.39001 Boehringer Ingelheim Investigational Site
      • Pordenone, Italy
        • 1218.62.39002 Boehringer Ingelheim Investigational Site
      • Ravenna, Italy
        • 1218.62.39012 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1218.62.39007 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1218.62.39011 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Goyang, Korea, Republic of
        • 1218.62.82005 Boehringer Ingelheim Investigational Site
      • Goyang, Korea, Republic of
        • 1218.62.82006 Boehringer Ingelheim Investigational Site
      • Incheon, Korea, Republic of
        • 1218.62.82003 Boehringer Ingelheim Investigational Site
      • Pucheon, Korea, Republic of
        • 1218.62.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1218.62.82002 Boehringer Ingelheim Investigational Site
      • Suwon, Korea, Republic of
        • 1218.62.82001 Boehringer Ingelheim Investigational Site
  • Malaysia
      • Kelantan Kota Bahru, Malaysia
        • 1218.62.60001 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 1218.62.60005 Boehringer Ingelheim Investigational Site
      • Penang, Malaysia
        • 1218.62.60002 Boehringer Ingelheim Investigational Site
      • Putrajaya, Malaysia
        • 1218.62.60003 Boehringer Ingelheim Investigational Site
      • Seremban, Malaysia
        • 1218.62.60004 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Almere, Netherlands
        • 1218.62.31007 Boehringer Ingelheim Investigational Site
      • Breezerveld, Netherlands
        • 1218.62.31004 Boehringer Ingelheim Investigational Site
      • Etten-Leur, Netherlands
        • 1218.62.31005 Boehringer Ingelheim Investigational Site
      • Lieshout, Netherlands
        • 1218.62.31002 Boehringer Ingelheim Investigational Site
      • Oude Pekela, Netherlands
        • 1218.62.31001 Boehringer Ingelheim Investigational Site
      • Voerendaal, Netherlands
        • 1218.62.31008 Boehringer Ingelheim Investigational Site
      • Wildervank, Netherlands
        • 1218.62.31009 Boehringer Ingelheim Investigational Site
      • Woerden, Netherlands
        • 1218.62.31003 Boehringer Ingelheim Investigational Site
  • Spain
      • Badia del Vallés (Barcelona), Spain
        • 1218.62.34003 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat (Barcelona), Spain
        • 1218.62.34002 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1218.62.34005 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1218.62.34006 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1218.62.34007 Boehringer Ingelheim Investigational Site
      • Palma (Mallorca), Spain
        • 1218.62.34001 Boehringer Ingelheim Investigational Site
      • Palma de Mallorca, Spain
        • 1218.62.34008 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. Diagnosis of type 2 diabetes mellitus.
  2. Current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. Metformin must be administered in twice daily dosing regimen. Patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
  3. Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.
  4. Body Mass Index (BMI) </=45 kg/m2.

Exclusion criteria

  1. Treatment with extended release metformin.
  2. Uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dL or 13.3 mmol/L).
  3. Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months prior to informed consent.
  4. Impaired hepatic or renal function, or gastric bypass surgery.
  5. Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.
  6. Current treatment with systemic steroids or change in dosage of thyroid hormones.
  7. Alcohol or drug abuse within 3 months of informed consent.
  8. Participation in another trial with investigational drug within 2 months prior to informed consent.
  9. Pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: linagliptin low dose
linagliptin low dose twice daily
Drug: linagliptin low dose
patient to receive tablets containing low dose linagliptin twice daily
Placebo Comparator: placebo
placebo matching linagliptin
Drug: placebo
patient to receive placebo tablet(s) matching linagliptin
Experimental: linagliptin medium dose
linagliptin medium dose once daily
Drug: linagliptin medium dose
patient to receive a tablet containing medium dose linagliptin once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.
Baseline and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Time Frame: Baseline and week 6
Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Baseline and week 6
HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Time Frame: Baseline and week 12
Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Baseline and week 12
FPG Change From Baseline at Week 12
Time Frame: Baseline and week 12
Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.
Baseline and week 12
FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Time Frame: Baseline and week 6
Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Baseline and week 6
FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Time Frame: Baseline and week 12
Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Baseline and week 12
Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12
Time Frame: Week 12
Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.
Week 12
Percentage of Patients With Rescue Therapy
Time Frame: 12 weeks
Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.
12 weeks
The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment
Time Frame: 12 weeks
Percentage of those patients with baseline HbA1c >= 7.0% who had HbA1c < 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.
12 weeks
The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment
Time Frame: 12 weeks
Percentage of those patients with baseline HbA1c >= 6.5% who had HbA1c < 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.
12 weeks

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

November 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.62
  • 2009-013549-27 (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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