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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01306214
First received: February 28, 2011
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Obesity
Drug: Placebo
Drug: BI 10773
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in HbA1c After 18 Weeks of Treatment [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
    The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.


Secondary Outcome Measures:
  • Change From Baseline in Insulin Dose After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment

  • Change From Baseline in Body Weight After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment

  • Change From Baseline in HbA1c After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment


Enrollment: 566
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low dose
BI 10773 low dose once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Drug: BI 10773
BI 10773 low dose once daily
Experimental: BI 10773 high dose
BI 10733 high dose once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: BI 10773
BI 10773 high dose once daily
Placebo Comparator: Placebo
Placebo tablets matching BI 10773
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306214

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Locations
United States, Alabama
1245.49.10005 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arizona
1245.49.10011 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
1245.49.10004 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
United States, California
1245.49.10002 Boehringer Ingelheim Investigational Site
Corona, California, United States
1245.49.10013 Boehringer Ingelheim Investigational Site
El Cajon, California, United States
1245.49.10030 Boehringer Ingelheim Investigational Site
Lomita, California, United States
1245.49.10014 Boehringer Ingelheim Investigational Site
Spring Valley, California, United States
1245.49.10019 Boehringer Ingelheim Investigational Site
Westlake Village, California, United States
United States, Colorado
1245.49.10024 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, Florida
1245.49.10018 Boehringer Ingelheim Investigational Site
Hialeah, Florida, United States
1245.49.10016 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
United States, Georgia
1245.49.10021 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia, United States
United States, Illinois
1245.49.10009 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Indiana
1245.49.10015 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
United States, North Carolina
1245.49.10023 Boehringer Ingelheim Investigational Site
Greenville, North Carolina, United States
United States, North Dakota
1245.49.10007 Boehringer Ingelheim Investigational Site
Fargo, North Dakota, United States
United States, Ohio
1245.49.10006 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
United States, South Carolina
1245.49.10025 Boehringer Ingelheim Investigational Site
Greer, South Carolina, United States
United States, Tennessee
1245.49.10022 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
United States, Texas
1245.49.10003 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1245.49.10001 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1245.49.10031 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, Utah
1245.49.10033 Boehringer Ingelheim Investigational Site
Bountiful, Utah, United States
1245.49.10032 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
United States, Virginia
1245.49.10026 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
United States, Washington
1245.49.10020 Boehringer Ingelheim Investigational Site
Renton, Washington, United States
Belgium
1245.49.32010 Boehringer Ingelheim Investigational Site
Bonheiden, Belgium
1245.49.32002 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1245.49.32007 Boehringer Ingelheim Investigational Site
Huy, Belgium
1245.49.32014 Boehringer Ingelheim Investigational Site
Jette, Belgium
1245.49.32013 Boehringer Ingelheim Investigational Site
La Louvière, Belgium
1245.49.32012 Boehringer Ingelheim Investigational Site
Leuven, Belgium
Bulgaria
1245.49.59003 Boehringer Ingelheim Investigational Site
Pleven, Bulgaria
1245.49.59004 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1245.49.59001 Boehringer Ingelheim Investigational Site
Stara Zagora, Bulgaria
Colombia
1245.49.57003 Boehringer Ingelheim Investigational Site
Barranquilla, Colombia
1245.49.57005 Boehringer Ingelheim Investigational Site
Bogota, Colombia
1245.49.57006 Boehringer Ingelheim Investigational Site
Bogota, Colombia
1245.49.57004 Boehringer Ingelheim Investigational Site
Bogotá, Colombia
1245.49.57002 Boehringer Ingelheim Investigational Site
Medellín, Colombia
Czech Republic
1245.49.42013 Boehringer Ingelheim Investigational Site
Breclav, Czech Republic
1245.49.42003 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1245.49.42010 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1245.49.42011 Boehringer Ingelheim Investigational Site
Chrudim, Czech Republic
1245.49.42009 Boehringer Ingelheim Investigational Site
Hodonin, Czech Republic
1245.49.42012 Boehringer Ingelheim Investigational Site
Svitavy56802, Czech Republic
Finland
1245.49.72001 Boehringer Ingelheim Investigational Site
Kuopio, Finland
1245.49.72002 Boehringer Ingelheim Investigational Site
Oulu, Finland
1245.49.72003 Boehringer Ingelheim Investigational Site
Turku, Finland
France
1245.49.33001 Boehringer Ingelheim Investigational Site
Grenoble Cedex, France
1245.49.33011 Boehringer Ingelheim Investigational Site
Le Creusot, France
1245.49.33012 Boehringer Ingelheim Investigational Site
Marseille, France
1245.49.33003 Boehringer Ingelheim Investigational Site
Nantes cedex 1, France
1245.49.33010 Boehringer Ingelheim Investigational Site
Narbonne Cedex, France
1245.49.33004 Boehringer Ingelheim Investigational Site
Pierre Benite, France
1245.49.33007 Boehringer Ingelheim Investigational Site
Point-à-Pitre Cedex, France
1245.49.33008 Boehringer Ingelheim Investigational Site
Saint Priest en Jarez, France
1245.49.33009 Boehringer Ingelheim Investigational Site
Vénissieux Cedex, France
Germany
1245.49.49104 Boehringer Ingelheim Investigational Site
Bosenheim, Germany
1245.49.49013 Boehringer Ingelheim Investigational Site
Dresden, Germany
1245.49.49101 Boehringer Ingelheim Investigational Site
Mainz, Germany
1245.49.49002 Boehringer Ingelheim Investigational Site
Neuwied, Germany
1245.49.49005 Boehringer Ingelheim Investigational Site
Saarbrücken, Germany
1245.49.49102 Boehringer Ingelheim Investigational Site
Wangen, Germany
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
Guatemala, Guatemala
1245.49.50205 Boehringer Ingelheim Investigational Site
Quetzaltenango, Guatemala
Mexico
1245.49.52011 Boehringer Ingelheim Investigational Site
Aguascalientes, Mexico
1245.49.52012 Boehringer Ingelheim Investigational Site
Cuautla, Mexico
1245.49.52003 Boehringer Ingelheim Investigational Site
Durango, Mexico
1245.49.52005 Boehringer Ingelheim Investigational Site
Durango, Mexico
1245.49.52006 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
1245.49.52008 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
1245.49.52004 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
1245.49.52009 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
1245.49.52010 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
1245.49.52002 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
1245.49.52001 Boehringer Ingelheim Investigational Site
México, D.F., Mexico
Peru
1245.49.51002 Boehringer Ingelheim Investigational Site
Arequipa, Peru
1245.49.51006 Boehringer Ingelheim Investigational Site
Arequipa, Peru
1245.49.51010 Boehringer Ingelheim Investigational Site
Jesus Maria, Peru
1245.49.51001 Boehringer Ingelheim Investigational Site
Lima, Peru
1245.49.51009 Boehringer Ingelheim Investigational Site
Lima, Peru
1245.49.51008 Boehringer Ingelheim Investigational Site
Lima, Peru
Russian Federation
1245.49.70008 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1245.49.70009 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1245.49.70006 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1245.49.70010 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Spain
1245.49.34039 Boehringer Ingelheim Investigational Site
Avila, Spain
1245.49.34038 Boehringer Ingelheim Investigational Site
Madrid, Spain
1245.49.34044 Boehringer Ingelheim Investigational Site
Madrid, Spain
1245.49.34043 Boehringer Ingelheim Investigational Site
MBoadilla del Monte (Madrid), Spain
1245.49.34047 Boehringer Ingelheim Investigational Site
Palma de Mallorca, Spain
1245.49.34045 Boehringer Ingelheim Investigational Site
pozuelo de Alarcon, Spain
1245.49.34016 Boehringer Ingelheim Investigational Site
Santiago de Compostela (La Coruña), Spain
1245.49.34041 Boehringer Ingelheim Investigational Site
Valencia, Spain
Ukraine
1245.49.75016 Boehringer Ingelheim Investigational Site
Kharkov, 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
Kiev, Ukraine
1245.49.75013 Boehringer Ingelheim Investigational Site
Kyiv, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01306214     History of Changes
Other Study ID Numbers: 1245.49, 2010-019968-37
Study First Received: February 28, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Bulgaria: Bulgarian Drug Agency
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Guatemala:
Mexico: Federal Commission for Protection Against Health Risks
Peru: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014