Clinical trial NCT01164501: Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Renal Insufficiency
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-07-16
Enrollment: 741
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 study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.


Eligibility criteria: Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent and an estimated glomerular filtration rate of \<90 ml/min.
2. Male and female patients on diet and exercise regimen who are pre-treated with any antidiabetic therapy and are on the maximum tolerated dose which has been unchanged for 12 weeks prior to randomisation.
3. HbA1c greater than or equal to 7.0% and less than or equal to 10.0% .
4. Aged 18 years or above.
5. Body Mass Index less than or equal to 45 kg/m2

Exclusion criteria:

1. Uncontrolled hyperglycaemia defined as \>13.3 mmol/L after an overnight fast during placebo run-in.
2. Impaired renal function, defined as an estimated glomerular filtration rate \<15 ml/min.
3. Renal impairment requiring any form of chronic dialysis.
4. Requiring acute dialysis within three months prior to informed consent.
5. Renal transplant recipient.
6. Myocardial infarction, stroke or Transient Ischemic Attack within three months prior to informed consent.
7. Indication of liver disease.
8. Bariatric surgery within the past two years.
9. Medical history of cancer.
10. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell.
11. Contraindications to pre-existing background antidiabetic therapy.
12. Treatment with anti-obesity drugs.
13. Current treatment with systemic steroids or change in dosage of thyroid hormones within six weeks prior to informed consent or any other uncontrolled endocrine disorder except Type 2 Diabetes.
14. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and are not practising an acceptable method of birth control.

Primary outcomes:
measure: HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment
timeFrame: Baseline and 24 weeks
measure: HbA1c Change From Baseline in Patients With Mild Renal Impairment
timeFrame: Baseline and 24 weeks
measure: HbA1c Change From Baseline in Patients With Moderate Renal Impairment
timeFrame: Baseline and 24 weeks
Secondary outcomes:
Other outcomes:
measure: Hypoglycaemic Events
timeFrame: From first drug administration until 7 days after last trial medication intake, up to 458 days
Locations:
city: Anaheim
country: United States
facility: 1245.36.10014 Boehringer Ingelheim Investigational Site
state: California
city: Lomita
country: United States
facility: 1245.36.10019 Boehringer Ingelheim Investigational Site
state: California
city: Plantation
country: United States
facility: 1245.36.10017 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 1245.36.10009 Boehringer Ingelheim Investigational Site
state: Florida
city: Honolulu
country: United States
facility: 1245.36.10018 Boehringer Ingelheim Investigational Site
state: Hawaii
city: Shreveport
country: United States
facility: 1245.36.10015 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Endwell
country: United States
facility: 1245.36.10021 Boehringer Ingelheim Investigational Site
state: New York
city: Greenville
country: United States
facility: 1245.36.10008 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Bethlehem
country: United States
facility: 1245.36.10005 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Melrose Park
country: United States
facility: 1245.36.10003 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: 1245.36.10004 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Corpus Christi
country: United States
facility: 1245.36.10012 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1245.36.10013 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1245.36.10002 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1245.36.10007 Boehringer Ingelheim Investigational Site
state: Texas
city: Renton
country: United States
facility: 1245.36.10023 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 1245.36.10011 Boehringer Ingelheim Investigational Site
state: Washington
city: Tacoma
country: United States
facility: 1245.36.10006 Boehringer Ingelheim Investigational Site
state: Washington
city: Calgary
country: Canada
facility: 1245.36.20052 Boehringer Ingelheim Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: 1245.36.20054 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1245.36.20023 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1245.36.20055 Boehringer Ingelheim Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: 1245.36.20048 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Mississauga
country: Canada
facility: 1245.36.20051 Boehringer Ingelheim Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: 1245.36.20086 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1245.36.20053 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1245.36.20056 Boehringer Ingelheim Investigational Site
state: Quebec
city: Corbeil Essonnes
country: France
facility: 1245.36.33001 Boehringer Ingelheim Investigational Site
city: Nanterre Cedex
country: France
facility: 1245.36.33042 Boehringer Ingelheim Investigational Site
city: Nice
country: France
facility: 1245.36.33041 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1245.36.33036 Boehringer Ingelheim Investigational Site
city: Poitiers
country: France
facility: 1245.36.33040 Boehringer Ingelheim Investigational Site
city: Reims Cedex
country: France
facility: 1245.36.33038 Boehringer Ingelheim Investigational Site
city: Reims
country: France
facility: 1245.36.33037 Boehringer Ingelheim Investigational Site
city: Rennes
country: France
facility: 1245.36.33043 Boehringer Ingelheim Investigational Site
city: Saint Mandé
country: France
facility: 1245.36.33044 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1245.36.85201 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1245.36.85204 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1245.36.85205 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1245.36.85206 Boehringer Ingelheim Investigational Site
city: Kowloon
country: Hong Kong
facility: 1245.36.85202 Boehringer Ingelheim Investigational Site
city: Aligarh, Uttar Pradesh
country: India
facility: 1245.36.91209 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.36.91202 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.36.91204 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.36.91205 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.36.91208 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1245.36.91201 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1245.36.91214 Boehringer Ingelheim Investigational Site
city: Gurgaon
country: India
facility: 1245.36.91213 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 1245.36.91203 Boehringer Ingelheim Investigational Site
city: Kolkata
country: India
facility: 1245.36.91211 Boehringer Ingelheim Investigational Site
city: Mangalore
country: India
facility: 1245.36.91210 Boehringer Ingelheim Investigational Site
city: Mumbai, Maharastra
country: India
facility: 1245.36.91215 Boehringer Ingelheim Investigational Site
city: Nasik
country: India
facility: 1245.36.91216 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 1245.36.91212 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1245.36.91207 Boehringer Ingelheim Investigational Site
city: Johor Baru
country: Malaysia
facility: 1245.36.60003 Boehringer Ingelheim Investigational Site
city: Kelantan Kota Bahru
country: Malaysia
facility: 1245.36.60006 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1245.36.60005 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1245.36.60009 Boehringer Ingelheim Investigational Site
city: Pahang
country: Malaysia
facility: 1245.36.60004 Boehringer Ingelheim Investigational Site
city: Perak
country: Malaysia
facility: 1245.36.60007 Boehringer Ingelheim Investigational Site
city: Perak
country: Malaysia
facility: 1245.36.60011 Boehringer Ingelheim Investigational Site
city: Pulau Piang
country: Malaysia
facility: 1245.36.60010 Boehringer Ingelheim Investigational Site
city: Sabah
country: Malaysia
facility: 1245.36.60008 Boehringer Ingelheim Investigational Site
city: Selangor Darul Ehsan
country: Malaysia
facility: 1245.36.60001 Boehringer Ingelheim Investigational Site
city: Amersfoort
country: Netherlands
facility: 1245.36.31015 Boehringer Ingelheim Investigational Site
city: Den Haag
country: Netherlands
facility: 1245.36.31004 Boehringer Ingelheim Investigational Site
city: Geleen
country: Netherlands
facility: 1245.36.31012 Boehringer Ingelheim Investigational Site
city: Hardenberg
country: Netherlands
facility: 1245.36.31017 Boehringer Ingelheim Investigational Site
city: Maastricht
country: Netherlands
facility: 1245.36.31009 Boehringer Ingelheim Investigational Site
city: Utrecht
country: Netherlands
facility: 1245.36.31002 Boehringer Ingelheim Investigational Site
city: Zaandam
country: Netherlands
facility: 1245.36.31003 Boehringer Ingelheim Investigational Site
city: Cavite City
country: Philippines
facility: 1245.36.63008 Boehringer Ingelheim Investigational Site
city: Cebu
country: Philippines
facility: 1245.36.63006 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1245.36.63005 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1245.36.63007 Boehringer Ingelheim Investigational Site
city: Marikina
country: Philippines
facility: 1245.36.63009 Boehringer Ingelheim Investigational Site
city: Tacloban
country: Philippines
facility: 1245.36.63010 Boehringer Ingelheim Investigational Site
city: Gdansk
country: Poland
facility: 1245.36.48006 Boehringer Ingelheim Investigational Site
city: Lodz
country: Poland
facility: 1245.36.48003 Boehringer Ingelheim Investigational Site
city: Lodz
country: Poland
facility: 1245.36.48004 Boehringer Ingelheim Investigational Site
city: Lublin
country: Poland
facility: 1245.36.48001 Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: 1245.36.48002 Boehringer Ingelheim Investigational Site
city: Ruda Slaska
country: Poland
facility: 1245.36.48007 Boehringer Ingelheim Investigational Site
city: Torun
country: Poland
facility: 1245.36.48005 Boehringer Ingelheim Investigational Site
city: Faro
country: Portugal
facility: 1245.36.35003 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1245.36.35002 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1245.36.35004 Boehringer Ingelheim Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: 1245.36.35001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1245.36.70008 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1245.36.70009 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1245.36.70011 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1245.36.70004 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1245.36.70006 Boehringer Ingelheim Investigational Site
city: Vsevolozhsk
country: Russian Federation
facility: 1245.36.70002 Boehringer Ingelheim Investigational Site
city: Moldava nad Bodvou
country: Slovakia
facility: 1245.36.74011 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1245.36.74013 Boehringer Ingelheim Investigational Site
city: Nove Mesto Nad Vahom
country: Slovakia
facility: 1245.36.74008 Boehringer Ingelheim Investigational Site
city: Presov
country: Slovakia
facility: 1245.36.74012 Boehringer Ingelheim Investigational Site
city: Trencin
country: Slovakia
facility: 1245.36.74007 Boehringer Ingelheim Investigational Site
city: Zilina
country: Slovakia
facility: 1245.36.74009 Boehringer Ingelheim Investigational Site
city: Plumstead
country: South Africa
facility: 1245.36.76021 Boehringer Ingelheim Investigational Site
city: Somerset West
country: South Africa
facility: 1245.36.76020 Boehringer Ingelheim Investigational Site
city: Somerset West
country: South Africa
facility: 1245.36.76022 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1245.36.34015 Boehringer Ingelheim Investigational Site
city: Granada
country: Spain
facility: 1245.36.34009 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat
country: Spain
facility: 1245.36.34014 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1245.36.34012 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1245.36.34013 Boehringer Ingelheim Investigational Site
city: Manresa
country: Spain
facility: 1245.36.34020 Boehringer Ingelheim Investigational Site
city: San Sebastian de los Reyes
country: Spain
facility: 1245.36.34021 Boehringer Ingelheim Investigational Site
city: Santiago de Compostela
country: Spain
facility: 1245.36.34016 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1245.36.34017 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1245.36.34019 Boehringer Ingelheim Investigational Site
city: Bath
country: United Kingdom
facility: 1245.36.44018 Boehringer Ingelheim Investigational Site
city: Birmingham
country: United Kingdom
facility: 1245.36.44010 Boehringer Ingelheim Investigational Site
city: Blackpool
country: United Kingdom
facility: 1245.36.44013 Boehringer Ingelheim Investigational Site
city: Blackpool
country: United Kingdom
facility: 1245.36.44016 Boehringer Ingelheim Investigational Site
city: Chesterfield
country: United Kingdom
facility: 1245.36.44012 Boehringer Ingelheim Investigational Site
city: Chester
country: United Kingdom
facility: 1245.36.44026 Boehringer Ingelheim Investigational Site
city: Doncaster
country: United Kingdom
facility: 1245.36.44025 Boehringer Ingelheim Investigational Site
city: Epsom
country: United Kingdom
facility: 1245.36.44036 Boehringer Ingelheim Investigational Site
city: Frome
country: United Kingdom
facility: 1245.36.44001 Boehringer Ingelheim Investigational Site
city: Midsomer Norton
country: United Kingdom
facility: 1245.36.44007 Boehringer Ingelheim Investigational Site
city: Nantwich
country: United Kingdom
facility: 1245.36.44023 Boehringer Ingelheim Investigational Site
city: Welwyn Garden City
country: United Kingdom
facility: 1245.36.44024 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: Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.
citation: Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.