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

NCT01649297 | Completed Phase 2 Results

• 2 other identifiers: 1276.102012-000905-53
• Study Type: interventional
• Target: 983
• Locations: 17 countries
• Sites: 135

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16

  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.

  Baseline and 16 weeks

Secondary Outcomes (1)

• Fasting Plasma Glucose (FPG) Change From Baseline at Week 16

  Baseline and 16 weeks

Study Arms (5)

empagliflozin (high dose qd)

EXPERIMENTAL

Patients receive Empagliflozin high dose once daily

Drug: Placebo; Drug: Empagliflozin (high dose qd)

empagliflozin (high dose bid)

EXPERIMENTAL

Patients receive Empagliflozin high dose split twice daily

Drug: Placebo; Drug: empagliflozin (high dose bid)

empagliflozin (low dose qd)

EXPERIMENTAL

Patients receive Empagliflozin low dose once daily

Drug: empagliflozin (low dose qd); Drug: Placebo

empagliflozin (low dose bid)

EXPERIMENTAL

Patients receive Empagliflozin low dose split twice daily

Drug: Placebo; Drug: empagliflozin (low dose bid)

Placebo

PLACEBO COMPARATOR

Patients receive placebo matching Empagliflozin

Drug: Placebo

Interventions

Placebo DRUG

Patients receive placebo matching empagliflozin (low dose qd)

empagliflozin (high dose qd)

empagliflozin (low dose qd) DRUG

Patients receive Empagliflozin low dose once daily

empagliflozin (low dose qd)

Empagliflozin (high dose qd) DRUG

Patients receive Empagliflozin high dose once daily

empagliflozin (high dose qd)

empagliflozin (high dose bid) DRUG

Patients receive Empagliflozin high dose split twice daily

empagliflozin (high dose bid)

empagliflozin (low dose bid) DRUG

Patients receive Empagliflozin low dose split twice daily

empagliflozin (low dose bid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (139)

1276.10.11036 Boehringer Ingelheim Investigational Site

Florence, Alabama, United States

Location

1276.10.11049 Boehringer Ingelheim Investigational Site

Jonesboro, Arkansas, United States

Location

1276.10.11040 Boehringer Ingelheim Investigational Site

Lomita, California, United States

Location

1276.10.11033 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1276.10.11002 Boehringer Ingelheim Investigational Site

Rancho Cucamonga, California, United States

Location

1276.10.11050 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

1276.10.11015 Boehringer Ingelheim Investigational Site

West Hills, California, United States

Location

1276.10.11012 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Location

1276.10.11047 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Location

1276.10.11010 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

Location

1276.10.11005 Boehringer Ingelheim Investigational Site

Davie, Florida, United States

Location

1276.10.11004 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1276.10.11051 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1276.10.11009 Boehringer Ingelheim Investigational Site

Oakland Park, Florida, United States

Location

1276.10.11044 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

Location

1276.10.11030 Boehringer Ingelheim Investigational Site

Dunwoody, Georgia, United States

Location

1276.10.11027 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1276.10.11020 Boehringer Ingelheim Investigational Site

Elwood, Indiana, United States

Location

1276.10.11001 Boehringer Ingelheim Investigational Site

Bangor, Maine, United States

Location

1276.10.11048 Boehringer Ingelheim Investigational Site

Sterling Heights, Michigan, United States

Location

1276.10.11058 Boehringer Ingelheim Investigational Site

Jackson, Mississippi, United States

Location

1276.10.11055 Boehringer Ingelheim Investigational Site

Edison, New Jersey, United States

Location

1276.10.11011 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Location

1276.10.11035 Boehringer Ingelheim Investigational Site

North Myrtle Beach, North Carolina, United States

Location

1276.10.11041 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1276.10.11018 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1276.10.11043 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

1276.10.11017 Boehringer Ingelheim Investigational Site

Kettering, Ohio, United States

Location

1276.10.11022 Boehringer Ingelheim Investigational Site

Fleetwood, Pennsylvania, United States

Location

1276.10.11003 Boehringer Ingelheim Investigational Site

Johnson City, Tennessee, United States

Location

1276.10.11042 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

Location

1276.10.11013 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1276.10.11026 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1276.10.11031 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1276.10.11034 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1276.10.11028 Boehringer Ingelheim Investigational Site

Pearland, Texas, United States

Location

1276.10.11029 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1276.10.11016 Boehringer Ingelheim Investigational Site

Port Orchard, Washington, United States

Location

1276.10.11024 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1276.10.61002 Boehringer Ingelheim Investigational Site

Wollongong, New South Wales, Australia

Location

1276.10.61001 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Location

1276.10.20008 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1276.10.20005 Boehringer Ingelheim Investigational Site

Surrey, British Columbia, Canada

Location

1276.10.20010 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1276.10.20002 Boehringer Ingelheim Investigational Site

Bathurst, New Brunswick, Canada

Location

1276.10.20001 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

Location

1276.10.20007 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

Location

1276.10.20006 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1276.10.20004 Boehringer Ingelheim Investigational Site

Drummondville, Quebec, Canada

Location

1276.10.20003 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Location

1276.10.20009 Boehringer Ingelheim Investigational Site

Victoriaville, Quebec, Canada

Location

1276.10.37203 Boehringer Ingelheim Investigational Site

Pärnu, Estonia

Location

1276.10.37201 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1276.10.37202 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1276.10.37204 Boehringer Ingelheim Investigational Site

Viljandi County, Estonia

Location

1276.10.33002 Boehringer Ingelheim Investigational Site

Aire-sur-l'Adour, France

Location

1276.10.33003 Boehringer Ingelheim Investigational Site

Bischheim, France

Location

1276.10.33009 Boehringer Ingelheim Investigational Site

Bourg-des-Comptes, France

Location

1276.10.33014 Boehringer Ingelheim Investigational Site

Bourges, France

Location

1276.10.33007 Boehringer Ingelheim Investigational Site

Broglie, France

Location

1276.10.33001 Boehringer Ingelheim Investigational Site

Mont-de-Marsan, France

Location

1276.10.33008 Boehringer Ingelheim Investigational Site

Paris, France

Location

1276.10.33006 Boehringer Ingelheim Investigational Site

Saint Vinecnt de Tyrosse, France

Location

1276.10.33011 Boehringer Ingelheim Investigational Site

Segré, France

Location

1276.10.33004 Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

1276.10.99501 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1276.10.99502 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1276.10.99503 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1276.10.99504 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1276.10.99505 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1276.10.99506 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1276.10.49001 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

Location

1276.10.49006 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1276.10.49007 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1276.10.49005 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1276.10.49004 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1276.10.49002 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1276.10.49003 Boehringer Ingelheim Investigational Site

Rehlingen-Siersburg, Germany

Location

1276.10.50201 Boehringer Ingelheim Investigational Site

Guatemala Ciudad, Guatemala

Location

1276.10.50203 Boehringer Ingelheim Investigational Site

Guatemala Ciudad, Guatemala

Location

1276.10.50204 Boehringer Ingelheim Investigational Site

Guatemala Ciudad, Guatemala

Location

1276.10.50205 Boehringer Ingelheim Investigational Site

Guatemala Ciudad, Guatemala

Location

1276.10.50202 Boehringer Ingelheim Investigational Site

Quetzaltenango Ciudad, Guatemala

Location

1276.10.39004 Boehringer Ingelheim Investigational Site

Arenzano (GE), Italy

Location

1276.10.39003 Boehringer Ingelheim Investigational Site

Bologna, Italy

Location

1276.10.39007 Boehringer Ingelheim Investigational Site

Catanzaro, Italy

Location

1276.10.39009 Boehringer Ingelheim Investigational Site

Catanzaro, Italy

Location

1276.10.39002 Boehringer Ingelheim Investigational Site

Napoli, Italy

Location

1276.10.39006 Boehringer Ingelheim Investigational Site

Palermo, Italy

Location

1276.10.39001 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1276.10.39008 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1276.10.39005 Boehringer Ingelheim Investigational Site

Torino, Italy

Location

1276.10.37102 Boehringer Ingelheim Investigational Site

Daugavpils, Latvia

Location

1276.10.37104 Boehringer Ingelheim Investigational Site

Ogre, Latvia

Location

1276.10.37101 Boehringer Ingelheim Investigational Site

Riga, Latvia

Location

1276.10.37103 Boehringer Ingelheim Investigational Site

Tukums, Latvia

Location

1276.10.37003 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

1276.10.37004 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

1276.10.37002 Boehringer Ingelheim Investigational Site

Klaipėda, Lithuania

Location

1276.10.37001 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

1276.10.52003 Boehringer Ingelheim Investigational Site

Durango, Mexico

Location

1276.10.52001 Boehringer Ingelheim Investigational Site

Mexico City, Mexico

Location

1276.10.52002 Boehringer Ingelheim Investigational Site

Mexico City, Mexico

Location

1276.10.52005 Boehringer Ingelheim Investigational Site

Pachuca, Mexico

Location

1276.10.52004 Boehringer Ingelheim Investigational Site

Tijuana, Mexico

Location

1276.10.64001 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1276.10.64002 Boehringer Ingelheim Investigational Site

Greenlane East Auckland NZ, New Zealand

Location

1276.10.48001 Boehringer Ingelheim Investigational Site

Bialystok, Poland

Location

1276.10.48002 Boehringer Ingelheim Investigational Site

Bialystok, Poland

Location

1276.10.48008 Boehringer Ingelheim Investigational Site

Giżycko, Poland

Location

1276.10.48005 Boehringer Ingelheim Investigational Site

Katowice, Poland

Location

1276.10.48006 Boehringer Ingelheim Investigational Site

Katowice, Poland

Location

1276.10.48004 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1276.10.48003 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1276.10.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1276.10.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1276.10.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1276.10.70004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1276.10.70005 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1276.10.70007 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1276.10.70008 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1276.10.70009 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1276.10.27004 Boehringer Ingelheim Investigational Site

Paarl, South Africa

Location

1276.10.27003 Boehringer Ingelheim Investigational Site

Parow, South Africa

Location

1276.10.27006 Boehringer Ingelheim Investigational Site

Plumstead, Cape Town, South Africa

Location

1276.10.27001 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

1276.10.27005 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

1276.10.27002 Boehringer Ingelheim Investigational Site

Somerset West, South Africa

Location

1276.10.34005 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1276.10.34001 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1276.10.34003 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1276.10.34002 Boehringer Ingelheim Investigational Site

les Borges del Camp, Spain

Location

1276.10.34004 Boehringer Ingelheim Investigational Site

Sant Adria Del Besos, Spain

Location

1276.10.34006 Boehringer Ingelheim Investigational Site

Vic, Spain

Location

1276.10.38002 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1276.10.38007 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1276.10.38001 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1276.10.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1276.10.38005 Boehringer Ingelheim Investigational Site

Kyiv, Ukraine

Location

Related Publications (1)

• Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

  PMID: 35472672 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; BID protein, human

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 23, 2015
• Results First Posted: July 23, 2015

Record last verified: 2015-06

Locations

UA (5); AU (2); ES (6); DE (7); LA (4); CA (10); LI (4); ME (5); GE (6); RU (8); ZA (6); PL (7); US (39); FR (10); NZ (2); GU (5); IT (9)