Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

May 16, 2014 updated by: Boehringer Ingelheim

A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Study Overview

Study Type

Interventional

Enrollment (Actual)

566

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

      • Bonheiden, Belgium
        • 1245.49.32010 Boehringer Ingelheim Investigational Site
      • Edegem, Belgium
        • 1245.49.32002 Boehringer Ingelheim Investigational Site
      • Huy, Belgium
        • 1245.49.32007 Boehringer Ingelheim Investigational Site
      • Jette, Belgium
        • 1245.49.32014 Boehringer Ingelheim Investigational Site
      • La Louvière, Belgium
        • 1245.49.32013 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 1245.49.32012 Boehringer Ingelheim Investigational Site
      • Pleven, Bulgaria
        • 1245.49.59003 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1245.49.59004 Boehringer Ingelheim Investigational Site
      • Stara Zagora, Bulgaria
        • 1245.49.59001 Boehringer Ingelheim Investigational Site
      • Barranquilla, Colombia
        • 1245.49.57003 Boehringer Ingelheim Investigational Site
      • Bogota, Colombia
        • 1245.49.57005 Boehringer Ingelheim Investigational Site
      • Bogota, Colombia
        • 1245.49.57006 Boehringer Ingelheim Investigational Site
      • Bogotá, Colombia
        • 1245.49.57004 Boehringer Ingelheim Investigational Site
      • Medellín, Colombia
        • 1245.49.57002 Boehringer Ingelheim Investigational Site
      • Breclav, Czech Republic
        • 1245.49.42013 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1245.49.42003 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1245.49.42010 Boehringer Ingelheim Investigational Site
      • Chrudim, Czech Republic
        • 1245.49.42011 Boehringer Ingelheim Investigational Site
      • Hodonin, Czech Republic
        • 1245.49.42009 Boehringer Ingelheim Investigational Site
      • Svitavy56802, Czech Republic
        • 1245.49.42012 Boehringer Ingelheim Investigational Site
      • Kuopio, Finland
        • 1245.49.72001 Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • 1245.49.72002 Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • 1245.49.72003 Boehringer Ingelheim Investigational Site
      • Grenoble Cedex, France
        • 1245.49.33001 Boehringer Ingelheim Investigational Site
      • Le Creusot, France
        • 1245.49.33011 Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1245.49.33012 Boehringer Ingelheim Investigational Site
      • Nantes cedex 1, France
        • 1245.49.33003 Boehringer Ingelheim Investigational Site
      • Narbonne Cedex, France
        • 1245.49.33010 Boehringer Ingelheim Investigational Site
      • Pierre Benite, France
        • 1245.49.33004 Boehringer Ingelheim Investigational Site
      • Point-à-Pitre Cedex, France
        • 1245.49.33007 Boehringer Ingelheim Investigational Site
      • Saint Priest en Jarez, France
        • 1245.49.33008 Boehringer Ingelheim Investigational Site
      • Vénissieux Cedex, France
        • 1245.49.33009 Boehringer Ingelheim Investigational Site
      • Bosenheim, Germany
        • 1245.49.49104 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1245.49.49013 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1245.49.49101 Boehringer Ingelheim Investigational Site
      • Neuwied, Germany
        • 1245.49.49002 Boehringer Ingelheim Investigational Site
      • Saarbrücken, Germany
        • 1245.49.49005 Boehringer Ingelheim Investigational Site
      • Wangen, Germany
        • 1245.49.49102 Boehringer Ingelheim Investigational Site
      • Guatemala, Guatemala
        • 1245.49.50201 Boehringer Ingelheim Investigational Site
      • Guatemala, Guatemala
        • 1245.49.50202 Boehringer Ingelheim Investigational Site
      • Guatemala, Guatemala
        • 1245.49.50203 Boehringer Ingelheim Investigational Site
      • Guatemala, Guatemala
        • 1245.49.50204 Boehringer Ingelheim Investigational Site
      • Quetzaltenango, Guatemala
        • 1245.49.50205 Boehringer Ingelheim Investigational Site
      • Aguascalientes, Mexico
        • 1245.49.52011 Boehringer Ingelheim Investigational Site
      • Cuautla, Mexico
        • 1245.49.52012 Boehringer Ingelheim Investigational Site
      • Durango, Mexico
        • 1245.49.52003 Boehringer Ingelheim Investigational Site
      • Durango, Mexico
        • 1245.49.52005 Boehringer Ingelheim Investigational Site
      • Guadalajara, Mexico
        • 1245.49.52004 Boehringer Ingelheim Investigational Site
      • Guadalajara, Mexico
        • 1245.49.52006 Boehringer Ingelheim Investigational Site
      • Guadalajara, Mexico
        • 1245.49.52008 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1245.49.52002 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1245.49.52009 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1245.49.52010 Boehringer Ingelheim Investigational Site
      • México, D.F., Mexico
        • 1245.49.52001 Boehringer Ingelheim Investigational Site
      • Arequipa, Peru
        • 1245.49.51002 Boehringer Ingelheim Investigational Site
      • Arequipa, Peru
        • 1245.49.51006 Boehringer Ingelheim Investigational Site
      • Jesus Maria, Peru
        • 1245.49.51010 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1245.49.51001 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1245.49.51008 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1245.49.51009 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1245.49.70008 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1245.49.70009 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1245.49.70006 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1245.49.70010 Boehringer Ingelheim Investigational Site
      • Avila, Spain
        • 1245.49.34039 Boehringer Ingelheim Investigational Site
      • MBoadilla del Monte (Madrid), Spain
        • 1245.49.34043 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1245.49.34038 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1245.49.34044 Boehringer Ingelheim Investigational Site
      • Palma de Mallorca, Spain
        • 1245.49.34047 Boehringer Ingelheim Investigational Site
      • Santiago de Compostela (La Coruña), Spain
        • 1245.49.34016 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1245.49.34041 Boehringer Ingelheim Investigational Site
      • pozuelo de Alarcon, Spain
        • 1245.49.34045 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1245.49.75016 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1245.49.75007 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1245.49.75014 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1245.49.75015 Boehringer Ingelheim Investigational Site
      • Kyiv, Ukraine
        • 1245.49.75013 Boehringer Ingelheim Investigational Site
    • Alabama
      • Birmingham, Alabama, United States
        • 1245.49.10005 Boehringer Ingelheim Investigational Site
    • Arizona
      • Chandler, Arizona, United States
        • 1245.49.10011 Boehringer Ingelheim Investigational Site
      • Tucson, Arizona, United States
        • 1245.49.10004 Boehringer Ingelheim Investigational Site
    • California
      • Corona, California, United States
        • 1245.49.10002 Boehringer Ingelheim Investigational Site
      • El Cajon, California, United States
        • 1245.49.10013 Boehringer Ingelheim Investigational Site
      • Lomita, California, United States
        • 1245.49.10030 Boehringer Ingelheim Investigational Site
      • Spring Valley, California, United States
        • 1245.49.10014 Boehringer Ingelheim Investigational Site
      • Westlake Village, California, United States
        • 1245.49.10019 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • 1245.49.10024 Boehringer Ingelheim Investigational Site
    • Florida
      • Hialeah, Florida, United States
        • 1245.49.10018 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1245.49.10016 Boehringer Ingelheim Investigational Site
    • Georgia
      • Blue Ridge, Georgia, United States
        • 1245.49.10021 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1245.49.10009 Boehringer Ingelheim Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • 1245.49.10015 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States
        • 1245.49.10023 Boehringer Ingelheim Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States
        • 1245.49.10007 Boehringer Ingelheim Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • 1245.49.10006 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greer, South Carolina, United States
        • 1245.49.10025 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States
        • 1245.49.10022 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, United States
        • 1245.49.10003 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1245.49.10001 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1245.49.10031 Boehringer Ingelheim Investigational Site
    • Utah
      • Bountiful, Utah, United States
        • 1245.49.10033 Boehringer Ingelheim Investigational Site
      • Salt Lake City, Utah, United States
        • 1245.49.10032 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, United States
        • 1245.49.10026 Boehringer Ingelheim Investigational Site
    • Washington
      • Renton, Washington, United States
        • 1245.49.10020 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. Diagnosis of T2DM prior to informed consent
  2. Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin
  3. Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose
  4. HbA1c >=7.5% and <=10% at screening

Exclusion criteria:

  1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
  2. Any contraindications to metformin according to the local label
  3. Acute coronary syndrome, stroke or TIA within 3 months 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
PLACEBO_COMPARATOR: Placebo
Placebo tablets matching BI 10773
Placebo matching BI 10773 low dose
Placebo matching BI 10773 high dose
EXPERIMENTAL: BI 10773 low dose
BI 10773 low dose once daily
Placebo matching BI 10773 low dose
BI 10773 high dose once daily
BI 10773 low dose once daily
Placebo matching BI 10773 high dose
EXPERIMENTAL: BI 10773 high dose
BI 10733 high dose once daily
Placebo matching BI 10773 low dose
BI 10773 high dose once daily
BI 10773 low dose once daily
Placebo matching BI 10773 high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c After 18 Weeks of Treatment
Time Frame: Baseline and 18 weeks
The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.
Baseline and 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Insulin Dose After 52 Weeks of Treatment
Time Frame: Baseline and 52 weeks
The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment
Baseline and 52 weeks
Change From Baseline in Body Weight After 52 Weeks of Treatment
Time Frame: Baseline and 52 weeks
The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment
Baseline and 52 weeks
Change From Baseline in HbA1c After 52 Weeks of Treatment
Time Frame: Baseline and 52 weeks
The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment
Baseline and 52 weeks

Collaborators and Investigators

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

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

February 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (ESTIMATE)

March 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

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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