12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus

NCT01370005 | Completed Phase 3 Results

• 2 other identifiers: 1245.482011-000347-25
• Study Type: interventional
• Target: 825
• Locations: 12 countries
• Sites: 120

Brief Summary

This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

Conditions

Diabetes Mellitus, Type 2; Hypertension

Outcome Measures

Primary Outcomes (2)

• HbA1c Change From Baseline

  Change from baseline in HbA1c after 12 weeks of treatment.

  Baseline and 12 weeks

• Mean 24-hour Systolic Blood Pressure Change From Baseline

  Change from baseline of mean 24-hour systolic blood pressure (SBP).

  Baseline and 12 weeks

Secondary Outcomes (13)

• Mean 24-hour Diastolic Blood Pressure Change From Baseline

  Baseline and 12 weeks

• Proportion of Patients With HbA1c <7%

  Baseline and 12 weeks

• Fasting Plasma Glucose (FPG) Change From Baseline

  Baseline and 12 weeks

• Body Weight Change From Baseline

  Baseline and 12 weeks

• Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline

  Baseline and 12 weeks

Other Outcomes (1)

• Confirmed Hypoglycaemic Adverse Events

  From drug administration until last drug administration plus seven days, up to 171 days

Study Arms (3)

BI 10773 low dose

EXPERIMENTAL

BI 10773 low dose once daily

Drug: Placebo; Drug: BI 10773

BI 10773 high dose

EXPERIMENTAL

BI 10773 high dose once daily

Drug: BI 10773; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo tablets matching BI 10773

Drug: Placebo

Interventions

Placebo DRUG

Placebo matching BI 10773 low dose

BI 10773 low dose

BI 10773 DRUG

BI 10773 high dose once daily

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:

• Patients \>=18 years with type 2 diabetes
• HbA1c of \>= 7.0% (53 mmol/mol) and =\< 10% (86 mmol/mol)
• Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg

You may not qualify if:

• Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast before randomization
• Known or suspected secondary hypertension
• Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent

Sponsors & Collaborators

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

Study Sites (120)

1245.48.10024 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

1245.48.10002 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1245.48.10014 Boehringer Ingelheim Investigational Site

Lincoln, California, United States

Location

1245.48.10030 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1245.48.10033 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1245.48.10027 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1245.48.10041 Boehringer Ingelheim Investigational Site

Tustin, California, United States

Location

1245.48.10039 Boehringer Ingelheim Investigational Site

West Hills, California, United States

Location

1245.48.10008 Boehringer Ingelheim Investigational Site

Davie, Florida, United States

Location

1245.48.10025 Boehringer Ingelheim Investigational Site

Edgewater, Florida, United States

Location

1245.48.10001 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1245.48.10016 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1245.48.10035 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

Location

1245.48.10018 Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

Location

1245.48.10032 Boehringer Ingelheim Investigational Site

Pinellas Park, Florida, United States

Location

1245.48.10012 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

1245.48.10011 Boehringer Ingelheim Investigational Site

Addison, Illinois, United States

Location

1245.48.10019 Boehringer Ingelheim Investigational Site

Arlington Heights, Illinois, United States

Location

1245.48.10022 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1245.48.10017 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

1245.48.10010 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1245.48.10036 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1245.48.10005 Boehringer Ingelheim Investigational Site

Akron, Ohio, United States

Location

1245.48.10004 Boehringer Ingelheim Investigational Site

Kettering, Ohio, United States

Location

1245.48.10013 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

Location

1245.48.10020 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1245.48.10029 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Location

1245.48.10015 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

1245.48.10034 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1245.48.10007 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1245.48.10009 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1245.48.10042 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1245.48.10026 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1245.48.10003 Boehringer Ingelheim Investigational Site

Orem, Utah, United States

Location

1245.48.10023 Boehringer Ingelheim Investigational Site

Port Orchard, Washington, United States

Location

1245.48.20002 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1245.48.20001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

1245.48.20004 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

Location

1245.48.20006 Boehringer Ingelheim Investigational Site

Etobicoke, Ontario, Canada

Location

1245.48.20007 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Location

1245.48.20005 Boehringer Ingelheim Investigational Site

Thornhill, Ontario, Canada

Location

1245.48.20003 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1245.48.42003 Boehringer Ingelheim Investigational Site

Benešov, Czechia

Location

1245.48.42005 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1245.48.42002 Boehringer Ingelheim Investigational Site

Mladá Boleslav, Czechia

Location

1245.48.42006 Boehringer Ingelheim Investigational Site

Neratovice, Czechia

Location

1245.48.42008 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

1245.48.42004 Boehringer Ingelheim Investigational Site

Opočno, Czechia

Location

1245.48.42007 Boehringer Ingelheim Investigational Site

Příbram, Czechia

Location

1245.48.42001 Boehringer Ingelheim Investigational Site

Slaný, Czechia

Location

1245.48.45006 Boehringer Ingelheim Investigational Site

Aalborg, Denmark

Location

1245.48.45009 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1245.48.45002 Boehringer Ingelheim Investigational Site

Elsinore, Denmark

Location

1245.48.45008 Boehringer Ingelheim Investigational Site

Hellerup, Denmark

Location

1245.48.45010 Boehringer Ingelheim Investigational Site

Hillerød, Denmark

Location

1245.48.45003 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

1245.48.45001 Boehringer Ingelheim Investigational Site

Rødovre Municipality, Denmark

Location

1245.48.45004 Boehringer Ingelheim Investigational Site

Rødovre Municipality, Denmark

Location

1245.48.45005 Boehringer Ingelheim Investigational Site

Vaerløse, Denmark

Location

1245.48.45007 Boehringer Ingelheim Investigational Site

Vojens, Denmark

Location

1245.48.37203 Boehringer Ingelheim Investigational Site

Pärnu, Estonia

Location

1245.48.37201 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.48.37202 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.48.37204 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.48.35802 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

1245.48.35805 Boehringer Ingelheim Investigational Site

Joensuu, Finland

Location

1245.48.35806 Boehringer Ingelheim Investigational Site

Kouvola, Finland

Location

1245.48.35803 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1245.48.35804 Boehringer Ingelheim Investigational Site

Pori, Finland

Location

1245.48.35801 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1245.48.35807 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1245.48.33004 Boehringer Ingelheim Investigational Site

Angers, France

Location

1245.48.33008 Boehringer Ingelheim Investigational Site

Bourges, France

Location

1245.48.33005 Boehringer Ingelheim Investigational Site

Mont-de-Marsan, France

Location

1245.48.33001 Boehringer Ingelheim Investigational Site

Nantes, France

Location

1245.48.33006 Boehringer Ingelheim Investigational Site

Orthez, France

Location

1245.48.33003 Boehringer Ingelheim Investigational Site

Tiercé, France

Location

1245.48.33007 Boehringer Ingelheim Investigational Site

Tours, France

Location

1245.48.49001 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1245.48.49008 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1245.48.49003 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1245.48.49004 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1245.48.49005 Boehringer Ingelheim Investigational Site

Lüneburg, Germany

Location

1245.48.49002 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1245.48.49010 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1245.48.49009 Boehringer Ingelheim Investigational Site

Pirna, Germany

Location

1245.48.49007 Boehringer Ingelheim Investigational Site

Schkeuditz, Germany

Location

1245.48.49006 Boehringer Ingelheim Investigational Site

Teuchern, Germany

Location

1245.48.96003 Boehringer Ingelheim Investigational Site

Baabda, Lebanon

Location

1245.48.96001 Boehringer Ingelheim Investigational Site

Beirut, Lebanon

Location

1245.48.96002 Boehringer Ingelheim Investigational Site

Lebanon, Lebanon

Location

1245.48.31011 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1245.48.31012 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1245.48.31009 Boehringer Ingelheim Investigational Site

Etten-Leur, Netherlands

Location

1245.48.31014 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

Location

1245.48.31013 Boehringer Ingelheim Investigational Site

Leiderdorp, Netherlands

Location

1245.48.31003 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

1245.48.31016 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1245.48.31006 Boehringer Ingelheim Investigational Site

Soerendonk, Netherlands

Location

1245.48.31008 Boehringer Ingelheim Investigational Site

Spijkenisse, Netherlands

Location

1245.48.31002 Boehringer Ingelheim Investigational Site

Swifterbant, Netherlands

Location

1245.48.31015 Boehringer Ingelheim Investigational Site

Velp, Netherlands

Location

1245.48.31010 Boehringer Ingelheim Investigational Site

Woerden, Netherlands

Location

1245.48.31019 Boehringer Ingelheim Investigational Site

Zijndrecht, Netherlands

Location

1245.48.31017 Boehringer Ingelheim Investigational Site

Zoetermeer, Netherlands

Location

1245.48.47009 Boehringer Ingelheim Investigational Site

Ålesund, Norway

Location

1245.48.47008 Boehringer Ingelheim Investigational Site

Elverum, Norway

Location

1245.48.47007 Boehringer Ingelheim Investigational Site

Hamar, Norway

Location

1245.48.47002 Boehringer Ingelheim Investigational Site

Kløfta, Norway

Location

1245.48.47001 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1245.48.47003 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1245.48.47004 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1245.48.47005 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1245.48.47006 Boehringer Ingelheim Investigational Site

Sørumsand, Norway

Location

1245.48.46002 Boehringer Ingelheim Investigational Site

Härnösand, Sweden

Location

1245.48.46004 Boehringer Ingelheim Investigational Site

Järfälla, Sweden

Location

1245.48.46003 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

1245.48.46007 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1245.48.46006 Boehringer Ingelheim Investigational Site

Skene, Sweden

Location

1245.48.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

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

• Mancia G, Cannon CP, Tikkanen I, Zeller C, Ley L, Woerle HJ, Broedl UC, Johansen OE. Impact of Empagliflozin on Blood Pressure in Patients With Type 2 Diabetes Mellitus and Hypertension by Background Antihypertensive Medication. Hypertension. 2016 Dec;68(6):1355-1364. doi: 10.1161/HYPERTENSIONAHA.116.07703. Epub 2016 Oct 10.

  PMID: 27977392 DERIVED

• Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, Woerle HJ; EMPA-REG BP Investigators. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care. 2015 Mar;38(3):420-8. doi: 10.2337/dc14-1096. Epub 2014 Sep 30.

  PMID: 25271206 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

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

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: June 8, 2011
• First Posted: June 9, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 22, 2016
• Results First Posted: June 17, 2014

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

CA (7); CZ (8); FR (7); DK (10); ES (4); DE (10); FI (7); NO (9); NL (14); LE (3); SE (6); US (35)