Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment

NCT01164501 | Completed Phase 3 Results

• 2 other identifiers: 1245.362009-016179-31
• Study Type: interventional
• Target: 741
• Locations: 15 countries
• Sites: 127

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.

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency

Outcome Measures

Primary Outcomes (3)

• HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment

  Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided.

  Baseline and 24 weeks

• HbA1c Change From Baseline in Patients With Mild Renal Impairment

  Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment. Note adjusted means are provided.

  Baseline and 24 weeks

• HbA1c Change From Baseline in Patients With Moderate Renal Impairment

  Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment. Note adjusted means are provided.

  Baseline and 24 weeks

Other Outcomes (1)

• Hypoglycaemic Events

  From first drug administration until 7 days after last trial medication intake, up to 458 days

Study Arms (3)

BI 10773 low dose

EXPERIMENTAL

BI 10773 tablets once daily

Drug: BI 10773; Drug: Placebo

BI 10773 high dose

EXPERIMENTAL

BI 10773 tablets once daily

Drug: Placebo; Drug: BI 10773

Placebo

PLACEBO COMPARATOR

Placebo tablets matching BI 10773

Drug: Placebo

Interventions

BI 10773 DRUG

BI 10773 tablets once daily

BI 10773 low dose

Placebo DRUG

Placebo tablets identical to BI 10773 low dose

BI 10773 high dose

Eligibility Criteria

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

You may qualify if:

• Diagnosis of type 2 diabetes mellitus prior to informed consent and an estimated glomerular filtration rate of \<90 ml/min.
• 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.
• HbA1c greater than or equal to 7.0% and less than or equal to 10.0% .
• Aged 18 years or above.
• Body Mass Index less than or equal to 45 kg/m2

You may not qualify if:

• Uncontrolled hyperglycaemia defined as \>13.3 mmol/L after an overnight fast during placebo run-in.
• Impaired renal function, defined as an estimated glomerular filtration rate \<15 ml/min.
• Renal impairment requiring any form of chronic dialysis.
• Requiring acute dialysis within three months prior to informed consent.
• Renal transplant recipient.
• Myocardial infarction, stroke or Transient Ischemic Attack within three months prior to informed consent.
• Indication of liver disease.
• Bariatric surgery within the past two years.
• Medical history of cancer.
• Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell.
• Contraindications to pre-existing background antidiabetic therapy.
• Treatment with anti-obesity drugs.
• 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.
• Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and are not practising an acceptable method of birth control.

Sponsors & Collaborators

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

Study Sites (127)

1245.36.10014 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Location

1245.36.10019 Boehringer Ingelheim Investigational Site

Lomita, California, United States

Location

1245.36.10017 Boehringer Ingelheim Investigational Site

Plantation, Florida, United States

Location

1245.36.10009 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

1245.36.10018 Boehringer Ingelheim Investigational Site

Honolulu, Hawaii, United States

Location

1245.36.10015 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

1245.36.10021 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Location

1245.36.10008 Boehringer Ingelheim Investigational Site

Greenville, North Carolina, United States

Location

1245.36.10005 Boehringer Ingelheim Investigational Site

Bethlehem, Pennsylvania, United States

Location

1245.36.10003 Boehringer Ingelheim Investigational Site

Melrose Park, Pennsylvania, United States

Location

1245.36.10004 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1245.36.10012 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

Location

1245.36.10013 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1245.36.10002 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1245.36.10007 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1245.36.10023 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Location

1245.36.10011 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1245.36.10006 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1245.36.20052 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1245.36.20054 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1245.36.20023 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1245.36.20055 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1245.36.20048 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1245.36.20051 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Location

1245.36.20086 Boehringer Ingelheim Investigational Site

Thornhill, Ontario, Canada

Location

1245.36.20053 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1245.36.20056 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1245.36.33001 Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, France

Location

1245.36.33042 Boehringer Ingelheim Investigational Site

Nanterre, France

Location

1245.36.33041 Boehringer Ingelheim Investigational Site

Nice, France

Location

1245.36.33036 Boehringer Ingelheim Investigational Site

Paris, France

Location

1245.36.33040 Boehringer Ingelheim Investigational Site

Poitiers, France

Location

1245.36.33037 Boehringer Ingelheim Investigational Site

Reims, France

Location

1245.36.33038 Boehringer Ingelheim Investigational Site

Reims, France

Location

1245.36.33043 Boehringer Ingelheim Investigational Site

Rennes, France

Location

1245.36.33044 Boehringer Ingelheim Investigational Site

Saint-Mandé, France

Location

1245.36.85201 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1245.36.85204 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1245.36.85205 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1245.36.85206 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1245.36.85202 Boehringer Ingelheim Investigational Site

Kowloon, Hong Kong

Location

1245.36.91209 Boehringer Ingelheim Investigational Site

Aligarh, Uttar Pradesh, India

Location

1245.36.91202 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1245.36.91204 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1245.36.91205 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1245.36.91208 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1245.36.91201 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1245.36.91214 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1245.36.91213 Boehringer Ingelheim Investigational Site

Gūrgaon, India

Location

1245.36.91203 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

1245.36.91211 Boehringer Ingelheim Investigational Site

Kolkata, India

Location

1245.36.91210 Boehringer Ingelheim Investigational Site

Mangalore, India

Location

1245.36.91215 Boehringer Ingelheim Investigational Site

Mumbai, Maharastra, India

Location

1245.36.91216 Boehringer Ingelheim Investigational Site

Nashik, India

Location

1245.36.91212 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

1245.36.91207 Boehringer Ingelheim Investigational Site

Pune, India

Location

1245.36.60003 Boehringer Ingelheim Investigational Site

Johor Baru, Malaysia

Location

1245.36.60006 Boehringer Ingelheim Investigational Site

Kelantan Kota Bahru, Malaysia

Location

1245.36.60005 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

1245.36.60009 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

1245.36.60004 Boehringer Ingelheim Investigational Site

Kuala Pahang, Malaysia

Location

1245.36.60007 Boehringer Ingelheim Investigational Site

Perak, Malaysia

Location

1245.36.60011 Boehringer Ingelheim Investigational Site

Perak, Malaysia

Location

1245.36.60010 Boehringer Ingelheim Investigational Site

Pulau Piang, Malaysia

Location

1245.36.60008 Boehringer Ingelheim Investigational Site

Sabak Bernam, Malaysia

Location

1245.36.60001 Boehringer Ingelheim Investigational Site

Selangor Darul Ehsan, Malaysia

Location

1245.36.31015 Boehringer Ingelheim Investigational Site

Amersfoort, Netherlands

Location

1245.36.31012 Boehringer Ingelheim Investigational Site

Geleen, Netherlands

Location

1245.36.31017 Boehringer Ingelheim Investigational Site

Hardenberg, Netherlands

Location

1245.36.31009 Boehringer Ingelheim Investigational Site

Maastricht, Netherlands

Location

1245.36.31004 Boehringer Ingelheim Investigational Site

The Hague, Netherlands

Location

1245.36.31002 Boehringer Ingelheim Investigational Site

Utrecht, Netherlands

Location

1245.36.31003 Boehringer Ingelheim Investigational Site

Zaandam, Netherlands

Location

1245.36.63008 Boehringer Ingelheim Investigational Site

Cavite City, Philippines

Location

1245.36.63006 Boehringer Ingelheim Investigational Site

Cebu, Philippines

Location

1245.36.63005 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1245.36.63007 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1245.36.63009 Boehringer Ingelheim Investigational Site

Marikina City, Philippines

Location

1245.36.63010 Boehringer Ingelheim Investigational Site

Tacloban City, Philippines

Location

1245.36.48006 Boehringer Ingelheim Investigational Site

Gdansk, Poland

Location

1245.36.48003 Boehringer Ingelheim Investigational Site

Lodz, Poland

Location

1245.36.48004 Boehringer Ingelheim Investigational Site

Lodz, Poland

Location

1245.36.48001 Boehringer Ingelheim Investigational Site

Lublin, Poland

Location

1245.36.48002 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

1245.36.48007 Boehringer Ingelheim Investigational Site

Ruda Śląska, Poland

Location

1245.36.48005 Boehringer Ingelheim Investigational Site

Torun, Poland

Location

1245.36.35003 Boehringer Ingelheim Investigational Site

Faro, Portugal

Location

1245.36.35002 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1245.36.35004 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1245.36.35001 Boehringer Ingelheim Investigational Site

Vila Nova de Gaia, Portugal

Location

1245.36.70008 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.36.70009 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.36.70011 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.36.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1245.36.70006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1245.36.70002 Boehringer Ingelheim Investigational Site

Vsevolozhsk, Russia

Location

1245.36.74011 Boehringer Ingelheim Investigational Site

Moldava nad Bodvou, Slovakia

Location

1245.36.74013 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1245.36.74008 Boehringer Ingelheim Investigational Site

Nové Mesto nad Váhom, Slovakia

Location

1245.36.74012 Boehringer Ingelheim Investigational Site

Prešov, Slovakia

Location

1245.36.74007 Boehringer Ingelheim Investigational Site

Trenčín, Slovakia

Location

1245.36.74009 Boehringer Ingelheim Investigational Site

Žilina, Slovakia

Location

1245.36.76021 Boehringer Ingelheim Investigational Site

Plumstead, South Africa

Location

1245.36.76020 Boehringer Ingelheim Investigational Site

Somerset West, South Africa

Location

1245.36.76022 Boehringer Ingelheim Investigational Site

Somerset West, South Africa

Location

1245.36.34015 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1245.36.34009 Boehringer Ingelheim Investigational Site

Granada, Spain

Location

1245.36.34014 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1245.36.34012 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1245.36.34013 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1245.36.34020 Boehringer Ingelheim Investigational Site

Manresa, Spain

Location

1245.36.34021 Boehringer Ingelheim Investigational Site

San Sebastián de los Reyes, Spain

Location

1245.36.34016 Boehringer Ingelheim Investigational Site

Santiago de Compostela, Spain

Location

1245.36.34017 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1245.36.34019 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1245.36.44018 Boehringer Ingelheim Investigational Site

Bath, United Kingdom

Location

1245.36.44010 Boehringer Ingelheim Investigational Site

Birmingham, United Kingdom

Location

1245.36.44013 Boehringer Ingelheim Investigational Site

Blackpool, United Kingdom

Location

1245.36.44016 Boehringer Ingelheim Investigational Site

Blackpool, United Kingdom

Location

1245.36.44026 Boehringer Ingelheim Investigational Site

Chester, United Kingdom

Location

1245.36.44012 Boehringer Ingelheim Investigational Site

Chesterfield, United Kingdom

Location

1245.36.44025 Boehringer Ingelheim Investigational Site

Doncaster, United Kingdom

Location

1245.36.44036 Boehringer Ingelheim Investigational Site

Epsom, United Kingdom

Location

1245.36.44001 Boehringer Ingelheim Investigational Site

Frome, United Kingdom

Location

1245.36.44007 Boehringer Ingelheim Investigational Site

Midsomer Norton, United Kingdom

Location

1245.36.44023 Boehringer Ingelheim Investigational Site

Nantwich, United Kingdom

Location

1245.36.44024 Boehringer Ingelheim Investigational Site

Welwyn Garden City, United Kingdom

Location

Related Publications (4)

• Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

  PMID: 38770818 DERIVED

• 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

• 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.

  PMID: 27316632 DERIVED

• 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.

  PMID: 24795251 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

In this trial, only patients with mild or moderate renal impairment were analysed. Patients with severe or no renal impairment were not analysed.

Results Point of Contact

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

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 16, 2014
• Results First Posted: June 16, 2014

Record last verified: 2014-05

Locations

CA (9); IN (15); SL (6); PH (6); PT (4); ES (10); NL (7); ZA (3); RU (6); HK (5); US (18); PL (7); FR (9); GB (12); MY (10)