Clinical trial NCT01649297: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2012-07-25
Enrollment: 983
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

1. confirmed diagnosis of T2DM
2. Glycated hemoglobin (HbA1c) \>=7.0 and \<=10/0% at Visit 1
3. Metformin therapy (at least 1500 mg/day, BID)
4. age\>=18 at Visit 1
5. body mass index \<=45 kg/m2

Exclusion criteria:

1. estimated creatinine clearance rate (eCCr) \<60 ml/min (Cockcroft-Gault formula) screening and/or run-in
2. a confirmed glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in

Primary outcomes:
measure: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Florence
country: United States
facility: 1276.10.11036 Boehringer Ingelheim Investigational Site
state: Alabama
city: Jonesboro
country: United States
facility: 1276.10.11049 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Lomita
country: United States
facility: 1276.10.11040 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1276.10.11033 Boehringer Ingelheim Investigational Site
state: California
city: Rancho Cucamonga
country: United States
facility: 1276.10.11002 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 1276.10.11050 Boehringer Ingelheim Investigational Site
state: California
city: West Hills
country: United States
facility: 1276.10.11015 Boehringer Ingelheim Investigational Site
state: California
city: Norwalk
country: United States
facility: 1276.10.11012 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: 1276.10.11047 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Bradenton
country: United States
facility: 1276.10.11010 Boehringer Ingelheim Investigational Site
state: Florida
city: Davie
country: United States
facility: 1276.10.11005 Boehringer Ingelheim Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: 1276.10.11004 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1276.10.11051 Boehringer Ingelheim Investigational Site
state: Florida
city: Oakland Park
country: United States
facility: 1276.10.11009 Boehringer Ingelheim Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: 1276.10.11044 Boehringer Ingelheim Investigational Site
state: Florida
city: Dunwoody
country: United States
facility: 1276.10.11030 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1276.10.11027 Boehringer Ingelheim Investigational Site
state: Illinois
city: Elwood
country: United States
facility: 1276.10.11020 Boehringer Ingelheim Investigational Site
state: Indiana
city: Bangor
country: United States
facility: 1276.10.11001 Boehringer Ingelheim Investigational Site
state: Maine
city: Sterling Heights
country: United States
facility: 1276.10.11048 Boehringer Ingelheim Investigational Site
state: Michigan
city: Jackson
country: United States
facility: 1276.10.11058 Boehringer Ingelheim Investigational Site
state: Mississippi
city: Edison
country: United States
facility: 1276.10.11055 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: 1276.10.11011 Boehringer Ingelheim Investigational Site
state: New York
city: North Myrtle Beach
country: United States
facility: 1276.10.11035 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 1276.10.11041 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 1276.10.11018 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 1276.10.11043 Boehringer Ingelheim Investigational Site
state: Ohio
city: Kettering
country: United States
facility: 1276.10.11017 Boehringer Ingelheim Investigational Site
state: Ohio
city: Fleetwood
country: United States
facility: 1276.10.11022 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Johnson City
country: United States
facility: 1276.10.11003 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: 1276.10.11042 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1276.10.11013 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1276.10.11026 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1276.10.11031 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1276.10.11034 Boehringer Ingelheim Investigational Site
state: Texas
city: Pearland
country: United States
facility: 1276.10.11028 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1276.10.11029 Boehringer Ingelheim Investigational Site
state: Texas
city: Port Orchard
country: United States
facility: 1276.10.11016 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 1276.10.11024 Boehringer Ingelheim Investigational Site
state: Washington
city: Wollongong
country: Australia
facility: 1276.10.61002 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Box Hill
country: Australia
facility: 1276.10.61001 Boehringer Ingelheim Investigational Site
state: Victoria
city: Calgary
country: Canada
facility: 1276.10.20008 Boehringer Ingelheim Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: 1276.10.20005 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 1276.10.20010 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Bathurst
country: Canada
facility: 1276.10.20002 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Brampton
country: Canada
facility: 1276.10.20001 Boehringer Ingelheim Investigational Site
state: Ontario
city: Corunna
country: Canada
facility: 1276.10.20007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: 1276.10.20006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Drummondville
country: Canada
facility: 1276.10.20004 Boehringer Ingelheim Investigational Site
state: Quebec
city: Point Claire
country: Canada
facility: 1276.10.20003 Boehringer Ingelheim Investigational Site
state: Quebec
city: Victoriaville
country: Canada
facility: 1276.10.20009 Boehringer Ingelheim Investigational Site
state: Quebec
city: Pärnu
country: Estonia
facility: 1276.10.37203 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1276.10.37201 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1276.10.37202 Boehringer Ingelheim Investigational Site
city: Viljandi County
country: Estonia
facility: 1276.10.37204 Boehringer Ingelheim Investigational Site
city: Aire sur l'Adour
country: France
facility: 1276.10.33002 Boehringer Ingelheim Investigational Site
city: Bischheim
country: France
facility: 1276.10.33003 Boehringer Ingelheim Investigational Site
city: Bourg des Comptes
country: France
facility: 1276.10.33009 Boehringer Ingelheim Investigational Site
city: Bourges
country: France
facility: 1276.10.33014 Boehringer Ingelheim Investigational Site
city: Broglie
country: France
facility: 1276.10.33007 Boehringer Ingelheim Investigational Site
city: Mont de Marsan
country: France
facility: 1276.10.33001 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1276.10.33008 Boehringer Ingelheim Investigational Site
city: Saint Vinecnt de Tyrosse
country: France
facility: 1276.10.33006 Boehringer Ingelheim Investigational Site
city: Segre
country: France
facility: 1276.10.33011 Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1276.10.33004 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1276.10.99501 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1276.10.99502 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1276.10.99503 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1276.10.99504 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1276.10.99505 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1276.10.99506 Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1276.10.49001 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1276.10.49006 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1276.10.49007 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1276.10.49005 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1276.10.49004 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1276.10.49002 Boehringer Ingelheim Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: 1276.10.49003 Boehringer Ingelheim Investigational Site
city: Guatemala Ciudad
country: Guatemala
facility: 1276.10.50201 Boehringer Ingelheim Investigational Site
city: Guatemala Ciudad
country: Guatemala
facility: 1276.10.50203 Boehringer Ingelheim Investigational Site
city: Guatemala Ciudad
country: Guatemala
facility: 1276.10.50204 Boehringer Ingelheim Investigational Site
city: Guatemala Ciudad
country: Guatemala
facility: 1276.10.50205 Boehringer Ingelheim Investigational Site
city: Quetzaltenango Ciudad
country: Guatemala
facility: 1276.10.50202 Boehringer Ingelheim Investigational Site
city: Arenzano (GE)
country: Italy
facility: 1276.10.39004 Boehringer Ingelheim Investigational Site
city: Bologna
country: Italy
facility: 1276.10.39003 Boehringer Ingelheim Investigational Site
city: Catanzaro
country: Italy
facility: 1276.10.39007 Boehringer Ingelheim Investigational Site
city: Catanzaro
country: Italy
facility: 1276.10.39009 Boehringer Ingelheim Investigational Site
city: Napoli
country: Italy
facility: 1276.10.39002 Boehringer Ingelheim Investigational Site
city: Palermo
country: Italy
facility: 1276.10.39006 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1276.10.39001 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1276.10.39008 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1276.10.39005 Boehringer Ingelheim Investigational Site
city: Daugavpils
country: Latvia
facility: 1276.10.37102 Boehringer Ingelheim Investigational Site
city: Ogre
country: Latvia
facility: 1276.10.37104 Boehringer Ingelheim Investigational Site
city: Riga
country: Latvia
facility: 1276.10.37101 Boehringer Ingelheim Investigational Site
city: Tukums
country: Latvia
facility: 1276.10.37103 Boehringer Ingelheim Investigational Site
city: Kaunas
country: Lithuania
facility: 1276.10.37003 Boehringer Ingelheim Investigational Site
city: Kaunas
country: Lithuania
facility: 1276.10.37004 Boehringer Ingelheim Investigational Site
city: Klaipeda
country: Lithuania
facility: 1276.10.37002 Boehringer Ingelheim Investigational Site
city: Vilnius
country: Lithuania
facility: 1276.10.37001 Boehringer Ingelheim Investigational Site
city: Ciudad de Mexico
country: Mexico
facility: 1276.10.52001 Boehringer Ingelheim Investigational Site
city: Ciudad de Mexico
country: Mexico
facility: 1276.10.52002 Boehringer Ingelheim Investigational Site
city: Durango
country: Mexico
facility: 1276.10.52003 Boehringer Ingelheim Investigational Site
city: Pachuca
country: Mexico
facility: 1276.10.52005 Boehringer Ingelheim Investigational Site
city: Tijuana
country: Mexico
facility: 1276.10.52004 Boehringer Ingelheim Investigational Site
city: Christchurch
country: New Zealand
facility: 1276.10.64001 Boehringer Ingelheim Investigational Site
city: Greenlane East Auckland NZ
country: New Zealand
facility: 1276.10.64002 Boehringer Ingelheim Investigational Site
city: Bialystok
country: Poland
facility: 1276.10.48001 Boehringer Ingelheim Investigational Site
city: Bialystok
country: Poland
facility: 1276.10.48002 Boehringer Ingelheim Investigational Site
city: Gizycko
country: Poland
facility: 1276.10.48008 Boehringer Ingelheim Investigational Site
city: Katowice
country: Poland
facility: 1276.10.48005 Boehringer Ingelheim Investigational Site
city: Katowice
country: Poland
facility: 1276.10.48006 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1276.10.48004 Boehringer Ingelheim Investigational Site
city: Warszawa
country: Poland
facility: 1276.10.48003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1276.10.70001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1276.10.70002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1276.10.70003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1276.10.70004 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1276.10.70005 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1276.10.70007 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1276.10.70008 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1276.10.70009 Boehringer Ingelheim Investigational Site
city: Paarl
country: South Africa
facility: 1276.10.27004 Boehringer Ingelheim Investigational Site
city: Parow
country: South Africa
facility: 1276.10.27003 Boehringer Ingelheim Investigational Site
city: Plumstead, Cape Town
country: South Africa
facility: 1276.10.27006 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1276.10.27001 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1276.10.27005 Boehringer Ingelheim Investigational Site
city: Somerset West
country: South Africa
facility: 1276.10.27002 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1276.10.34005 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat
country: Spain
facility: 1276.10.34001 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat
country: Spain
facility: 1276.10.34003 Boehringer Ingelheim Investigational Site
city: Les Borges del Camp
country: Spain
facility: 1276.10.34002 Boehringer Ingelheim Investigational Site
city: Sant Adria del Besos
country: Spain
facility: 1276.10.34004 Boehringer Ingelheim Investigational Site
city: Vic
country: Spain
facility: 1276.10.34006 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1276.10.38002 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1276.10.38007 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1276.10.38001 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1276.10.38004 Boehringer Ingelheim Investigational Site
city: Kyiv
country: Ukraine
facility: 1276.10.38005 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.