Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01306214 |
|
Recruitment Status
:
Completed
First Posted
: March 1, 2011
Results First Posted
: June 17, 2014
Last Update Posted
: June 17, 2014
|
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 Obesity | Drug: Placebo Drug: BI 10773 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 566 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| 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 |
| Study Start Date : | February 2011 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | April 2013 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
Drug Information available for:
Empagliflozin
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
|
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
|
Primary Outcome Measures
:
- 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.
Secondary Outcome Measures
:
- 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
- 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
- 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
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Diagnosis of T2DM prior to informed consent
- 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
- Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose
- HbA1c >=7.5% and <=10% at screening
Exclusion criteria:
- Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
- Any contraindications to metformin according to the local label
- Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306214
Hide Study Locations
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 | |
| 1245.49.52004 Boehringer Ingelheim Investigational Site | |
| Guadalajara, Mexico | |
| 1245.49.52006 Boehringer Ingelheim Investigational Site | |
| Guadalajara, Mexico | |
| 1245.49.52008 Boehringer Ingelheim Investigational Site | |
| Guadalajara, 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 | |
| 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 | |
| 1245.49.51008 Boehringer Ingelheim Investigational Site | |
| Lima, Peru | |
| 1245.49.51009 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 |
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 ( EudraCT Number: EudraCT ) |
| First Posted: | March 1, 2011 Key Record Dates |
| Results First Posted: | June 17, 2014 |
| Last Update Posted: | June 17, 2014 |
| Last Verified: | May 2014 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Empagliflozin Hypoglycemic Agents Physiological Effects of Drugs |