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:
Boehringer Ingelheim
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
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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:
- 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01306214
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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 | |
| 1245.49.52004 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 | |
| 1245.49.70009 Boehringer Ingelheim Investigational Site | |
| Moscow, Russian Federation | |
| 1245.49.70008 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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on March 02, 2015