A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
This study has been completed.
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01649297
First received: July 23, 2012
Last updated: June 26, 2015
Last verified: June 2015
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Purpose
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Placebo Drug: empagliflozin (low dose qd) Drug: Empagliflozin (high dose qd) Drug: empagliflozin (high dose bid) Drug: empagliflozin (low dose bid) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16 [ Time Frame: Baseline and 16 weeks ]
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.
Secondary Outcome Measures:
- Fasting Plasma Glucose (FPG) Change From Baseline at Week 16 [ Time Frame: Baseline and 16 weeks ]
Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.
| Enrollment: | 983 |
| Study Start Date: | October 2012 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
|
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Drug: Empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
|
|
Experimental: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
|
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Drug: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
|
|
Experimental: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
|
Drug: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
|
|
Experimental: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
|
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
|
|
Placebo Comparator: Placebo
Patients receive placebo matching Empagliflozin
|
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- confirmed diagnosis of T2DM
- Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
- Metformin therapy (at least 1500 mg/day, BID)
- age>=18 at Visit 1
- body mass index <=45 kg/m2
Exclusion criteria:
- estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
- a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649297
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01649297
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Locations
| United States, Alabama | |
| 1276.10.11036 Boehringer Ingelheim Investigational Site | |
| Florence, Alabama, United States | |
| United States, Arkansas | |
| 1276.10.11049 Boehringer Ingelheim Investigational Site | |
| Jonesboro, Arkansas, United States | |
| United States, California | |
| 1276.10.11040 Boehringer Ingelheim Investigational Site | |
| Lomita, California, United States | |
| 1276.10.11033 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 1276.10.11002 Boehringer Ingelheim Investigational Site | |
| Rancho Cucamonga, California, United States | |
| 1276.10.11050 Boehringer Ingelheim Investigational Site | |
| Sacramento, California, United States | |
| 1276.10.11015 Boehringer Ingelheim Investigational Site | |
| West Hills, California, United States | |
| United States, Connecticut | |
| 1276.10.11012 Boehringer Ingelheim Investigational Site | |
| Norwalk, Connecticut, United States | |
| 1276.10.11047 Boehringer Ingelheim Investigational Site | |
| Waterbury, Connecticut, United States | |
| United States, Florida | |
| 1276.10.11010 Boehringer Ingelheim Investigational Site | |
| Bradenton, Florida, United States | |
| 1276.10.11005 Boehringer Ingelheim Investigational Site | |
| Davie, Florida, United States | |
| 1276.10.11004 Boehringer Ingelheim Investigational Site | |
| Jacksonville, Florida, United States | |
| 1276.10.11051 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 1276.10.11009 Boehringer Ingelheim Investigational Site | |
| Oakland Park, Florida, United States | |
| 1276.10.11044 Boehringer Ingelheim Investigational Site | |
| Palm Harbor, Florida, United States | |
| United States, Georgia | |
| 1276.10.11030 Boehringer Ingelheim Investigational Site | |
| Dunwoody, Georgia, United States | |
| United States, Illinois | |
| 1276.10.11027 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| 1276.10.11020 Boehringer Ingelheim Investigational Site | |
| Elwood, Indiana, United States | |
| United States, Maine | |
| 1276.10.11001 Boehringer Ingelheim Investigational Site | |
| Bangor, Maine, United States | |
| United States, Michigan | |
| 1276.10.11048 Boehringer Ingelheim Investigational Site | |
| Sterling Heights, Michigan, United States | |
| United States, Mississippi | |
| 1276.10.11058 Boehringer Ingelheim Investigational Site | |
| Jackson, Mississippi, United States | |
| United States, New Jersey | |
| 1276.10.11055 Boehringer Ingelheim Investigational Site | |
| Edison, New Jersey, United States | |
| United States, New York | |
| 1276.10.11011 Boehringer Ingelheim Investigational Site | |
| Brooklyn, New York, United States | |
| United States, North Carolina | |
| 1276.10.11035 Boehringer Ingelheim Investigational Site | |
| North Myrtle Beach, North Carolina, United States | |
| 1276.10.11041 Boehringer Ingelheim Investigational Site | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| 1276.10.11018 Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| 1276.10.11043 Boehringer Ingelheim Investigational Site | |
| Dayton, Ohio, United States | |
| 1276.10.11017 Boehringer Ingelheim Investigational Site | |
| Kettering, Ohio, United States | |
| United States, Pennsylvania | |
| 1276.10.11022 Boehringer Ingelheim Investigational Site | |
| Fleetwood, Pennsylvania, United States | |
| United States, Tennessee | |
| 1276.10.11003 Boehringer Ingelheim Investigational Site | |
| Johnson City, Tennessee, United States | |
| United States, Texas | |
| 1276.10.11042 Boehringer Ingelheim Investigational Site | |
| Corpus Christi, Texas, United States | |
| 1276.10.11013 Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| 1276.10.11026 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| 1276.10.11031 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| 1276.10.11034 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| 1276.10.11028 Boehringer Ingelheim Investigational Site | |
| Pearland, Texas, United States | |
| 1276.10.11029 Boehringer Ingelheim Investigational Site | |
| San Antonio, Texas, United States | |
| United States, Washington | |
| 1276.10.11016 Boehringer Ingelheim Investigational Site | |
| Port Orchard, Washington, United States | |
| 1276.10.11024 Boehringer Ingelheim Investigational Site | |
| Spokane, Washington, United States | |
| Australia, New South Wales | |
| 1276.10.61002 Boehringer Ingelheim Investigational Site | |
| Wollongong, New South Wales, Australia | |
| Australia, Victoria | |
| 1276.10.61001 Boehringer Ingelheim Investigational Site | |
| Box Hill, Victoria, Australia | |
| Canada, Alberta | |
| 1276.10.20008 Boehringer Ingelheim Investigational Site | |
| Calgary, Alberta, Canada | |
| Canada, British Columbia | |
| 1276.10.20005 Boehringer Ingelheim Investigational Site | |
| Surrey, British Columbia, Canada | |
| Canada, Manitoba | |
| 1276.10.20010 Boehringer Ingelheim Investigational Site | |
| Winnipeg, Manitoba, Canada | |
| Canada, New Brunswick | |
| 1276.10.20002 Boehringer Ingelheim Investigational Site | |
| Bathurst, New Brunswick, Canada | |
| Canada, Ontario | |
| 1276.10.20001 Boehringer Ingelheim Investigational Site | |
| Brampton, Ontario, Canada | |
| 1276.10.20007 Boehringer Ingelheim Investigational Site | |
| Corunna, Ontario, Canada | |
| 1276.10.20006 Boehringer Ingelheim Investigational Site | |
| Sarnia, Ontario, Canada | |
| Canada, Quebec | |
| 1276.10.20004 Boehringer Ingelheim Investigational Site | |
| Drummondville, Quebec, Canada | |
| 1276.10.20003 Boehringer Ingelheim Investigational Site | |
| Point Claire, Quebec, Canada | |
| 1276.10.20009 Boehringer Ingelheim Investigational Site | |
| Victoriaville, Quebec, Canada | |
| Estonia | |
| 1276.10.37203 Boehringer Ingelheim Investigational Site | |
| Pärnu, Estonia | |
| 1276.10.37201 Boehringer Ingelheim Investigational Site | |
| Tallinn, Estonia | |
| 1276.10.37202 Boehringer Ingelheim Investigational Site | |
| Tallinn, Estonia | |
| 1276.10.37204 Boehringer Ingelheim Investigational Site | |
| Viljandi County, Estonia | |
| France | |
| 1276.10.33002 Boehringer Ingelheim Investigational Site | |
| Aire sur l'Adour, France | |
| 1276.10.33003 Boehringer Ingelheim Investigational Site | |
| Bischheim, France | |
| 1276.10.33009 Boehringer Ingelheim Investigational Site | |
| Bourg des Comptes, France | |
| 1276.10.33014 Boehringer Ingelheim Investigational Site | |
| Bourges, France | |
| 1276.10.33007 Boehringer Ingelheim Investigational Site | |
| Broglie, France | |
| 1276.10.33001 Boehringer Ingelheim Investigational Site | |
| Mont de Marsan, France | |
| 1276.10.33008 Boehringer Ingelheim Investigational Site | |
| Paris, France | |
| 1276.10.33006 Boehringer Ingelheim Investigational Site | |
| Saint Vinecnt de Tyrosse, France | |
| 1276.10.33011 Boehringer Ingelheim Investigational Site | |
| Segre, France | |
| 1276.10.33004 Boehringer Ingelheim Investigational Site | |
| Strasbourg, France | |
| Georgia | |
| 1276.10.99501 Boehringer Ingelheim Investigational Site | |
| Tbilisi, Georgia | |
| 1276.10.99502 Boehringer Ingelheim Investigational Site | |
| Tbilisi, Georgia | |
| 1276.10.99503 Boehringer Ingelheim Investigational Site | |
| Tbilisi, Georgia | |
| 1276.10.99504 Boehringer Ingelheim Investigational Site | |
| Tbilisi, Georgia | |
| 1276.10.99505 Boehringer Ingelheim Investigational Site | |
| Tbilisi, Georgia | |
| 1276.10.99506 Boehringer Ingelheim Investigational Site | |
| Tbilisi, Georgia | |
| Germany | |
| 1276.10.49001 Boehringer Ingelheim Investigational Site | |
| Aschaffenburg, Germany | |
| 1276.10.49006 Boehringer Ingelheim Investigational Site | |
| Berlin, Germany | |
| 1276.10.49007 Boehringer Ingelheim Investigational Site | |
| Berlin, Germany | |
| 1276.10.49005 Boehringer Ingelheim Investigational Site | |
| Essen, Germany | |
| 1276.10.49004 Boehringer Ingelheim Investigational Site | |
| Frankfurt, Germany | |
| 1276.10.49002 Boehringer Ingelheim Investigational Site | |
| Nürnberg, Germany | |
| 1276.10.49003 Boehringer Ingelheim Investigational Site | |
| Rehlingen-Siersburg, Germany | |
| Guatemala | |
| 1276.10.50201 Boehringer Ingelheim Investigational Site | |
| Guatemala Ciudad, Guatemala | |
| 1276.10.50203 Boehringer Ingelheim Investigational Site | |
| Guatemala Ciudad, Guatemala | |
| 1276.10.50204 Boehringer Ingelheim Investigational Site | |
| Guatemala Ciudad, Guatemala | |
| 1276.10.50205 Boehringer Ingelheim Investigational Site | |
| Guatemala Ciudad, Guatemala | |
| 1276.10.50202 Boehringer Ingelheim Investigational Site | |
| Quetzaltenango Ciudad, Guatemala | |
| Italy | |
| 1276.10.39004 Boehringer Ingelheim Investigational Site | |
| Arenzano (GE), Italy | |
| 1276.10.39003 Boehringer Ingelheim Investigational Site | |
| Bologna, Italy | |
| 1276.10.39007 Boehringer Ingelheim Investigational Site | |
| Catanzaro, Italy | |
| 1276.10.39009 Boehringer Ingelheim Investigational Site | |
| Catanzaro, Italy | |
| 1276.10.39002 Boehringer Ingelheim Investigational Site | |
| Napoli, Italy | |
| 1276.10.39006 Boehringer Ingelheim Investigational Site | |
| Palermo, Italy | |
| 1276.10.39001 Boehringer Ingelheim Investigational Site | |
| Roma, Italy | |
| 1276.10.39008 Boehringer Ingelheim Investigational Site | |
| Roma, Italy | |
| 1276.10.39005 Boehringer Ingelheim Investigational Site | |
| Torino, Italy | |
| Latvia | |
| 1276.10.37102 Boehringer Ingelheim Investigational Site | |
| Daugavpils, Latvia | |
| 1276.10.37104 Boehringer Ingelheim Investigational Site | |
| Ogre, Latvia | |
| 1276.10.37101 Boehringer Ingelheim Investigational Site | |
| Riga, Latvia | |
| 1276.10.37103 Boehringer Ingelheim Investigational Site | |
| Tukums, Latvia | |
| Lithuania | |
| 1276.10.37003 Boehringer Ingelheim Investigational Site | |
| Kaunas, Lithuania | |
| 1276.10.37004 Boehringer Ingelheim Investigational Site | |
| Kaunas, Lithuania | |
| 1276.10.37002 Boehringer Ingelheim Investigational Site | |
| Klaipeda, Lithuania | |
| 1276.10.37001 Boehringer Ingelheim Investigational Site | |
| Vilnius, Lithuania | |
| Mexico | |
| 1276.10.52001 Boehringer Ingelheim Investigational Site | |
| Ciudad de Mexico, Mexico | |
| 1276.10.52002 Boehringer Ingelheim Investigational Site | |
| Ciudad de Mexico, Mexico | |
| 1276.10.52003 Boehringer Ingelheim Investigational Site | |
| Durango, Mexico | |
| 1276.10.52005 Boehringer Ingelheim Investigational Site | |
| Pachuca, Mexico | |
| 1276.10.52004 Boehringer Ingelheim Investigational Site | |
| Tijuana, Mexico | |
| New Zealand | |
| 1276.10.64001 Boehringer Ingelheim Investigational Site | |
| Christchurch, New Zealand | |
| 1276.10.64002 Boehringer Ingelheim Investigational Site | |
| Greenlane East Auckland NZ, New Zealand | |
| Poland | |
| 1276.10.48001 Boehringer Ingelheim Investigational Site | |
| Bialystok, Poland | |
| 1276.10.48002 Boehringer Ingelheim Investigational Site | |
| Bialystok, Poland | |
| 1276.10.48008 Boehringer Ingelheim Investigational Site | |
| Gizycko, Poland | |
| 1276.10.48005 Boehringer Ingelheim Investigational Site | |
| Katowice, Poland | |
| 1276.10.48006 Boehringer Ingelheim Investigational Site | |
| Katowice, Poland | |
| 1276.10.48004 Boehringer Ingelheim Investigational Site | |
| Krakow, Poland | |
| 1276.10.48003 Boehringer Ingelheim Investigational Site | |
| Warszawa, Poland | |
| Russian Federation | |
| 1276.10.70001 Boehringer Ingelheim Investigational Site | |
| Moscow, Russian Federation | |
| 1276.10.70002 Boehringer Ingelheim Investigational Site | |
| Moscow, Russian Federation | |
| 1276.10.70003 Boehringer Ingelheim Investigational Site | |
| Moscow, Russian Federation | |
| 1276.10.70004 Boehringer Ingelheim Investigational Site | |
| Moscow, Russian Federation | |
| 1276.10.70005 Boehringer Ingelheim Investigational Site | |
| Moscow, Russian Federation | |
| 1276.10.70007 Boehringer Ingelheim Investigational Site | |
| Moscow, Russian Federation | |
| 1276.10.70008 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| 1276.10.70009 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| South Africa | |
| 1276.10.27004 Boehringer Ingelheim Investigational Site | |
| Paarl, South Africa | |
| 1276.10.27003 Boehringer Ingelheim Investigational Site | |
| Parow, South Africa | |
| 1276.10.27006 Boehringer Ingelheim Investigational Site | |
| Plumstead, Cape Town, South Africa | |
| 1276.10.27001 Boehringer Ingelheim Investigational Site | |
| Pretoria, South Africa | |
| 1276.10.27005 Boehringer Ingelheim Investigational Site | |
| Pretoria, South Africa | |
| 1276.10.27002 Boehringer Ingelheim Investigational Site | |
| Somerset West, South Africa | |
| Spain | |
| 1276.10.34005 Boehringer Ingelheim Investigational Site | |
| Barcelona, Spain | |
| 1276.10.34001 Boehringer Ingelheim Investigational Site | |
| L'Hospitalet de Llobregat, Spain | |
| 1276.10.34003 Boehringer Ingelheim Investigational Site | |
| L'Hospitalet de Llobregat, Spain | |
| 1276.10.34002 Boehringer Ingelheim Investigational Site | |
| Les Borges del Camp, Spain | |
| 1276.10.34004 Boehringer Ingelheim Investigational Site | |
| Sant Adria del Besos, Spain | |
| 1276.10.34006 Boehringer Ingelheim Investigational Site | |
| Vic, Spain | |
| Ukraine | |
| 1276.10.38002 Boehringer Ingelheim Investigational Site | |
| Kharkiv, Ukraine | |
| 1276.10.38007 Boehringer Ingelheim Investigational Site | |
| Kharkiv, Ukraine | |
| 1276.10.38001 Boehringer Ingelheim Investigational Site | |
| Kiev, Ukraine | |
| 1276.10.38004 Boehringer Ingelheim Investigational Site | |
| Kiev, Ukraine | |
| 1276.10.38005 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:
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01649297 History of Changes |
| Other Study ID Numbers: |
1276.10 2012-000905-53 ( EudraCT Number: EudraCT ) |
| Study First Received: | July 23, 2012 |
| Results First Received: | June 26, 2015 |
| Last Updated: | June 26, 2015 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Empagliflozin Metformin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2017