BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

May 16, 2014 updated by: Boehringer Ingelheim

A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy

The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

495

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

  • Argentina
      • Capital Federal, Argentina
        • 1245.10.54002 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1245.10.54004 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1245.10.54008 Boehringer Ingelheim Investigational Site
      • Mar del Plata, Argentina
        • 1245.10.54006 Boehringer Ingelheim Investigational Site
      • Mendoza, Argentina
        • 1245.10.54005 Boehringer Ingelheim Investigational Site
  • Austria
      • Graz, Austria
        • 1245.10.43002 Boehringer Ingelheim Investigational Site
      • Innsbruck, Austria
        • 1245.10.43004 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1245.10.43001 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1245.10.43003 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Breclav, Czech Republic
        • 1245.10.42001 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1245.10.42003 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1245.10.42005 Boehringer Ingelheim Investigational Site
      • Hodonin, Czech Republic
        • 1245.10.42002 Boehringer Ingelheim Investigational Site
  • Estonia
      • Tallin, Estonia
        • 1245.10.37201 Boehringer Ingelheim Investigational Site
      • Tartu, Estonia
        • 1245.10.37202 Boehringer Ingelheim Investigational Site
  • Finland
      • Kerava, Finland
        • 1245.10.58006 Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • 1245.10.58003 Boehringer Ingelheim Investigational Site
      • Tampere, Finland
        • 1245.10.58004 Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • 1245.10.58001 Boehringer Ingelheim Investigational Site
  • France
      • Bondy Cedex, France
        • 1245.10.3302A Boehringer Ingelheim Investigational Site
      • Bondy Cedex, France
        • 1245.10.3302B Boehringer Ingelheim Investigational Site
      • Caen Cedex 5, France
        • 1245.10.3310A Boehringer Ingelheim Investigational Site
      • Caen Cedex 5, France
        • 1245.10.3310B Boehringer Ingelheim Investigational Site
      • Caen Cedex 5, France
        • 1245.10.3310C Boehringer Ingelheim Investigational Site
      • Corbeil Essonnes, France
        • 1245.10.3301A Boehringer Ingelheim Investigational Site
      • Corbeil Essonnes, France
        • 1245.10.3301B Boehringer Ingelheim Investigational Site
      • La Rochelle Cedex 1, France
        • 1245.10.3303A Boehringer Ingelheim Investigational Site
      • La Rochelle Cedex 1, France
        • 1245.10.3303B Boehringer Ingelheim Investigational Site
      • La Rochelle Cedex 1, France
        • 1245.10.3303C Boehringer Ingelheim Investigational Site
      • La Rochelle Cedex 1, France
        • 1245.10.3303D Boehringer Ingelheim Investigational Site
      • Le Grau du Roi, France
        • 1245.10.3308A Boehringer Ingelheim Investigational Site
      • Le Grau du Roi, France
        • 1245.10.3308B Boehringer Ingelheim Investigational Site
      • Nanterre Cedex, France
        • 1245.10.3309A Boehringer Ingelheim Investigational Site
      • Narbonne Cedex, France
        • 1245.10.3306A Boehringer Ingelheim Investigational Site
      • Narbonne Cedex, France
        • 1245.10.3306B Boehringer Ingelheim Investigational Site
      • Quimper, France
        • 1245.10.3307A Boehringer Ingelheim Investigational Site
      • Reims Cedex, France
        • 1245.10.3304A Boehringer Ingelheim Investigational Site
      • Reims Cedex, France
        • 1245.10.3304B Boehringer Ingelheim Investigational Site
      • Reims Cedex, France
        • 1245.10.3304C Boehringer Ingelheim Investigational Site
      • Saint Mandé, France
        • 1245.10.3311A Boehringer Ingelheim Investigational Site
      • Saint Mandé, France
        • 1245.10.3311B Boehringer Ingelheim Investigational Site
      • Saint Mandé, France
        • 1245.10.3311C Boehringer Ingelheim Investigational Site
      • Saint Mandé, France
        • 1245.10.3311D Boehringer Ingelheim Investigational Site
      • Valenciennes, France
        • 1245.10.3305A Boehringer Ingelheim Investigational Site
      • Valenciennes, France
        • 1245.10.3305B Boehringer Ingelheim Investigational Site
      • Valenciennes, France
        • 1245.10.3305C Boehringer Ingelheim Investigational Site
      • Valenciennes, France
        • 1245.10.3305D Boehringer Ingelheim Investigational Site
  • Germany
      • Erlangen, Germany
        • 1245.10.49001 Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • 1245.10.49003 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1245.10.49002 Boehringer Ingelheim Investigational Site
      • Rehlingen-Siersburg, Germany
        • 1245.10.49004 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 1245.10.36001 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1245.10.36003 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1245.10.36004 Boehringer Ingelheim Investigational Site
      • Gyor, Hungary
        • 1245.10.36005 Boehringer Ingelheim Investigational Site
      • Szombathely, Hungary
        • 1245.10.36002 Boehringer Ingelheim Investigational Site
  • Latvia
      • Daugavpils, Latvia
        • 1245.10.37101 Boehringer Ingelheim Investigational Site
      • Kuldiga, Latvia
        • 1245.10.37105 Boehringer Ingelheim Investigational Site
      • Ogre, Latvia
        • 1245.10.37106 Boehringer Ingelheim Investigational Site
      • Riga, Latvia
        • 1245.10.37103 Boehringer Ingelheim Investigational Site
      • Riga, Latvia
        • 1245.10.37107 Boehringer Ingelheim Investigational Site
      • Talsi, Latvia
        • 1245.10.37102 Boehringer Ingelheim Investigational Site
      • Valmiera, Latvia
        • 1245.10.37104 Boehringer Ingelheim Investigational Site
  • Norway
      • Hamar, Norway
        • 1245.10.47003 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 1245.10.47005 Boehringer Ingelheim Investigational Site
      • Stavanger, Norway
        • 1245.10.47001 Boehringer Ingelheim Investigational Site
      • Ålesund, Norway
        • 1245.10.47004 Boehringer Ingelheim Investigational Site
  • Romania
      • Alba Iulia, Romania
        • 1245.10.40001 Boehringer Ingelheim Investigational Site
      • Baia Mare Maramures, Romania
        • 1245.10.40005 Boehringer Ingelheim Investigational Site
      • Brasov, Romania
        • 1245.10.40003 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1245.10.40002 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1245.10.40007 Boehringer Ingelheim Investigational Site
      • Galati, Romania
        • 1245.10.40004 Boehringer Ingelheim Investigational Site
      • Satu Mare, Romania
        • 1245.10.40006 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1245.10.70001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1245.10.70002 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1245.10.70003 Boehringer Ingelheim Investigational Site
      • Saratov, Russian Federation
        • 1245.10.70007 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1245.10.70004 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1245.10.70005 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1245.10.70006 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Bratislava, Slovakia
        • 1245.10.62003 Boehringer Ingelheim Investigational Site
      • Nitra, Slovakia
        • 1245.10.62001 Boehringer Ingelheim Investigational Site
      • Nitra, Slovakia
        • 1245.10.62002 Boehringer Ingelheim Investigational Site
      • Presov, Slovakia
        • 1245.10.62004 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 1245.10.34002 Boehringer Ingelheim Investigational Site
      • Girona, Spain
        • 1245.10.34001 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat (Barcelona), Spain
        • 1245.10.34010 Boehringer Ingelheim Investigational Site
      • Málaga, Spain
        • 1245.10.34004 Boehringer Ingelheim Investigational Site
      • Palma (Mallorca), Spain
        • 1245.10.34005 Boehringer Ingelheim Investigational Site
      • Palma de Mallorca, Spain
        • 1245.10.34006 Boehringer Ingelheim Investigational Site
      • Santander, Spain
        • 1245.10.34008 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • 1245.10.38002 Boehringer Ingelheim Investigational Site
      • Kharkiv, Ukraine
        • 1245.10.38005 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1245.10.38004 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1245.10.38003 Boehringer Ingelheim Investigational Site
      • Vinnitsa, Ukraine
        • 1245.10.38001 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • Chula Vista, California, United States
        • 1245.10.10026 Boehringer Ingelheim Investigational Site
      • Mission Viejo, California, United States
        • 1245.10.10001 Boehringer Ingelheim Investigational Site
      • Pasadena, California, United States
        • 1245.10.10011 Boehringer Ingelheim Investigational Site
      • Spring Valley, California, United States
        • 1245.10.10028 Boehringer Ingelheim Investigational Site
      • Walnut Creek, California, United States
        • 1245.10.10027 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwarter, Florida, United States
        • 1245.10.10004 Boehringer Ingelheim Investigational Site
      • Melbourne, Florida, United States
        • 1245.10.10021 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1245.10.10005 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1245.10.10019 Boehringer Ingelheim Investigational Site
      • St. Cloud, Florida, United States
        • 1245.10.10024 Boehringer Ingelheim Investigational Site
    • Georgia
      • Roswell, Georgia, United States
        • 1245.10.10014 Boehringer Ingelheim Investigational Site
    • New York
      • Staten Island, New York, United States
        • 1245.10.10016 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Shelby, North Carolina, United States
        • 1245.10.10009 Boehringer Ingelheim Investigational Site
    • Ohio
      • Wadsworth, Ohio, United States
        • 1245.10.10006 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Norristown, Pennsylvania, United States
        • 1245.10.10023 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Clemson, South Carolina, United States
        • 1245.10.10010 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1245.10.10015 Boehringer Ingelheim Investigational Site
      • Temple, Texas, United States
        • 1245.10.10012 Boehringer Ingelheim Investigational Site
    • Washington
      • Federal Way, Washington, United States
        • 1245.10.10025 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 79 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 one other oral antidiabetic drug
  2. Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
  3. HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only
  4. HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
  5. Age >=18 and <80years
  6. Body Mass Index (BMI) <=40 kg/m2
  7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (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. Renal insufficiency or impaired renal function
  4. Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
  5. Chronic or clinically relevant acute infections
  6. Current or chronic urogenital tract infection
  7. History of clinically relevant allergy/hypersensitivity
  8. Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
  9. Treatment with anti-obesity drugs within 3 months prior to informed consent
  10. Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  11. Alcohol abuse or drug abuse
  12. Treatment with an investigational drug within 2 months prior to informed consent
  13. Women of child-bearing potential who are nursing or pregnant, or who 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 periodic pregnancy testing during participation in the trial

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
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks

Change from baseline in HbA1c after 12 weeks of treatment.

In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of HbA1c From Baseline Over Time
Time Frame: Baseline and weeks 4, 8 and 12
Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.
Baseline and weeks 4, 8 and 12
Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)
Time Frame: Baseline and 12 weeks
HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.
Baseline and 12 weeks
Change of Body Weight After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks
Results for change of body weight after 12 weeks of treatment based on ANCOVA.
Baseline and 12 weeks
Change of FPG From Baseline After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks

Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.

In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.
Baseline and 12 weeks
Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks
Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression
Baseline and 12 weeks
Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks
Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression
Baseline and 12 weeks
Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)
Time Frame: Baseline and 12 weeks
Results for change of FPI from baseline at week 12 based on ANCOVA
Baseline and 12 weeks
Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)
Time Frame: Baseline and 12 weeks
HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.
Baseline and 12 weeks
Trough Concentrations of Empagliflozin in Plasma
Time Frame: Days 28, 56 and 84
(Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.
Days 28, 56 and 84

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

August 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245.10
  • EudraCT 2008-000641-54

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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