Clinical trial NCT01306214: Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2011-03-01
Enrollment: 566
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: 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.


Eligibility criteria: Inclusion criteria:

1. Diagnosis of T2DM prior to informed consent
2. 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
3. Stable metformin therapy: daily dose \>=1500 mg/day or maximum tolerated dose
4. HbA1c \>=7.5% and \<=10% at screening

Exclusion criteria:

1. Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in
2. Any contraindications to metformin according to the local label
3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent

Primary outcomes:
measure: Change From Baseline in HbA1c After 18 Weeks of Treatment
timeFrame: Baseline and 18 weeks
Secondary outcomes:
measure: Change From Baseline in Insulin Dose After 52 Weeks of Treatment
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in Body Weight After 52 Weeks of Treatment
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in HbA1c After 52 Weeks of Treatment
timeFrame: Baseline and 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1245.49.10005 Boehringer Ingelheim Investigational Site
state: Alabama
city: Chandler
country: United States
facility: 1245.49.10011 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: 1245.49.10004 Boehringer Ingelheim Investigational Site
state: Arizona
city: Corona
country: United States
facility: 1245.49.10002 Boehringer Ingelheim Investigational Site
state: California
city: El Cajon
country: United States
facility: 1245.49.10013 Boehringer Ingelheim Investigational Site
state: California
city: Lomita
country: United States
facility: 1245.49.10030 Boehringer Ingelheim Investigational Site
state: California
city: Spring Valley
country: United States
facility: 1245.49.10014 Boehringer Ingelheim Investigational Site
state: California
city: Westlake Village
country: United States
facility: 1245.49.10019 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 1245.49.10024 Boehringer Ingelheim Investigational Site
state: Colorado
city: Hialeah
country: United States
facility: 1245.49.10018 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1245.49.10016 Boehringer Ingelheim Investigational Site
state: Florida
city: Blue Ridge
country: United States
facility: 1245.49.10021 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1245.49.10009 Boehringer Ingelheim Investigational Site
state: Illinois
city: Evansville
country: United States
facility: 1245.49.10015 Boehringer Ingelheim Investigational Site
state: Indiana
city: Greenville
country: United States
facility: 1245.49.10023 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: 1245.49.10007 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Columbus
country: United States
facility: 1245.49.10006 Boehringer Ingelheim Investigational Site
state: Ohio
city: Greer
country: United States
facility: 1245.49.10025 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: 1245.49.10022 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Austin
country: United States
facility: 1245.49.10003 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1245.49.10001 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1245.49.10031 Boehringer Ingelheim Investigational Site
state: Texas
city: Bountiful
country: United States
facility: 1245.49.10033 Boehringer Ingelheim Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: 1245.49.10032 Boehringer Ingelheim Investigational Site
state: Utah
city: Norfolk
country: United States
facility: 1245.49.10026 Boehringer Ingelheim Investigational Site
state: Virginia
city: Renton
country: United States
facility: 1245.49.10020 Boehringer Ingelheim Investigational Site
state: Washington
city: Bonheiden
country: Belgium
facility: 1245.49.32010 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 1245.49.32002 Boehringer Ingelheim Investigational Site
city: Huy
country: Belgium
facility: 1245.49.32007 Boehringer Ingelheim Investigational Site
city: Jette
country: Belgium
facility: 1245.49.32014 Boehringer Ingelheim Investigational Site
city: La Louvière
country: Belgium
facility: 1245.49.32013 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1245.49.32012 Boehringer Ingelheim Investigational Site
city: Pleven
country: Bulgaria
facility: 1245.49.59003 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1245.49.59004 Boehringer Ingelheim Investigational Site
city: Stara Zagora
country: Bulgaria
facility: 1245.49.59001 Boehringer Ingelheim Investigational Site
city: Barranquilla
country: Colombia
facility: 1245.49.57003 Boehringer Ingelheim Investigational Site
city: Bogota
country: Colombia
facility: 1245.49.57005 Boehringer Ingelheim Investigational Site
city: Bogota
country: Colombia
facility: 1245.49.57006 Boehringer Ingelheim Investigational Site
city: Bogotá
country: Colombia
facility: 1245.49.57004 Boehringer Ingelheim Investigational Site
city: Medellín
country: Colombia
facility: 1245.49.57002 Boehringer Ingelheim Investigational Site
city: Breclav
country: Czech Republic
facility: 1245.49.42013 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1245.49.42003 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1245.49.42010 Boehringer Ingelheim Investigational Site
city: Chrudim
country: Czech Republic
facility: 1245.49.42011 Boehringer Ingelheim Investigational Site
city: Hodonin
country: Czech Republic
facility: 1245.49.42009 Boehringer Ingelheim Investigational Site
city: Svitavy56802
country: Czech Republic
facility: 1245.49.42012 Boehringer Ingelheim Investigational Site
city: Kuopio
country: Finland
facility: 1245.49.72001 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 1245.49.72002 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1245.49.72003 Boehringer Ingelheim Investigational Site
city: Grenoble Cedex
country: France
facility: 1245.49.33001 Boehringer Ingelheim Investigational Site
city: Le Creusot
country: France
facility: 1245.49.33011 Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1245.49.33012 Boehringer Ingelheim Investigational Site
city: Nantes cedex 1
country: France
facility: 1245.49.33003 Boehringer Ingelheim Investigational Site
city: Narbonne Cedex
country: France
facility: 1245.49.33010 Boehringer Ingelheim Investigational Site
city: Pierre Benite
country: France
facility: 1245.49.33004 Boehringer Ingelheim Investigational Site
city: Point-à-Pitre Cedex
country: France
facility: 1245.49.33007 Boehringer Ingelheim Investigational Site
city: Saint Priest en Jarez
country: France
facility: 1245.49.33008 Boehringer Ingelheim Investigational Site
city: Vénissieux Cedex
country: France
facility: 1245.49.33009 Boehringer Ingelheim Investigational Site
city: Bosenheim
country: Germany
facility: 1245.49.49104 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1245.49.49013 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1245.49.49101 Boehringer Ingelheim Investigational Site
city: Neuwied
country: Germany
facility: 1245.49.49002 Boehringer Ingelheim Investigational Site
city: Saarbrücken
country: Germany
facility: 1245.49.49005 Boehringer Ingelheim Investigational Site
city: Wangen
country: Germany
facility: 1245.49.49102 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1245.49.50201 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1245.49.50202 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1245.49.50203 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1245.49.50204 Boehringer Ingelheim Investigational Site
city: Quetzaltenango
country: Guatemala
facility: 1245.49.50205 Boehringer Ingelheim Investigational Site
city: Aguascalientes
country: Mexico
facility: 1245.49.52011 Boehringer Ingelheim Investigational Site
city: Cuautla
country: Mexico
facility: 1245.49.52012 Boehringer Ingelheim Investigational Site
city: Durango
country: Mexico
facility: 1245.49.52003 Boehringer Ingelheim Investigational Site
city: Durango
country: Mexico
facility: 1245.49.52005 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1245.49.52004 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1245.49.52006 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1245.49.52008 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1245.49.52002 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1245.49.52009 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1245.49.52010 Boehringer Ingelheim Investigational Site
city: México, D.F.
country: Mexico
facility: 1245.49.52001 Boehringer Ingelheim Investigational Site
city: Arequipa
country: Peru
facility: 1245.49.51002 Boehringer Ingelheim Investigational Site
city: Arequipa
country: Peru
facility: 1245.49.51006 Boehringer Ingelheim Investigational Site
city: Jesus Maria
country: Peru
facility: 1245.49.51010 Boehringer Ingelheim Investigational Site
city: Lima
country: Peru
facility: 1245.49.51001 Boehringer Ingelheim Investigational Site
city: Lima
country: Peru
facility: 1245.49.51008 Boehringer Ingelheim Investigational Site
city: Lima
country: Peru
facility: 1245.49.51009 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1245.49.70008 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1245.49.70009 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1245.49.70006 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1245.49.70010 Boehringer Ingelheim Investigational Site
city: Avila
country: Spain
facility: 1245.49.34039 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1245.49.34038 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1245.49.34044 Boehringer Ingelheim Investigational Site
city: MBoadilla del Monte (Madrid)
country: Spain
facility: 1245.49.34043 Boehringer Ingelheim Investigational Site
city: Palma de Mallorca
country: Spain
facility: 1245.49.34047 Boehringer Ingelheim Investigational Site
city: pozuelo de Alarcon
country: Spain
facility: 1245.49.34045 Boehringer Ingelheim Investigational Site
city: Santiago de Compostela (La Coruña)
country: Spain
facility: 1245.49.34016 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1245.49.34041 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1245.49.75016 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1245.49.75007 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1245.49.75014 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1245.49.75015 Boehringer Ingelheim Investigational Site
city: Kyiv
country: Ukraine
facility: 1245.49.75013 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.
citation: Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, Broedl UC; EMPA-REG MDI Trial Investigators. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014 Jul;37(7):1815-23. doi: 10.2337/dc13-3055. Epub 2014 Jun 14.