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

NCT ID: NCT01370005

Last Updated: 2016-02-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

825 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-07-31

Brief Summary

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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

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24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension

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A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication

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Type 2 Diabetes
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A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 10773 low dose

BI 10773 low dose once daily

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

BI 10773

Intervention Type DRUG

BI 10773 low dose once daily

BI 10773 high dose

BI 10773 high dose once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 high dose once daily

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

Placebo

Placebo tablets matching BI 10773

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

Interventions

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Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

BI 10773

BI 10773 high dose once daily

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

BI 10773

BI 10773 low dose once daily

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1245.48.10024 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Site Status

1245.48.10002 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

1245.48.10014 Boehringer Ingelheim Investigational Site

Lincoln, California, United States

Site Status

1245.48.10030 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Site Status

1245.48.10033 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Site Status

1245.48.10027 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1245.48.10041 Boehringer Ingelheim Investigational Site

Tustin, California, United States

Site Status

1245.48.10039 Boehringer Ingelheim Investigational Site

West Hills, California, United States

Site Status

1245.48.10008 Boehringer Ingelheim Investigational Site

Davie, Florida, United States

Site Status

1245.48.10025 Boehringer Ingelheim Investigational Site

Edgewater, Florida, United States

Site Status

1245.48.10001 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Site Status

1245.48.10016 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1245.48.10035 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

Site Status

1245.48.10018 Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

Site Status

1245.48.10032 Boehringer Ingelheim Investigational Site

Pinellas Park, Florida, United States

Site Status

1245.48.10012 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Site Status

1245.48.10011 Boehringer Ingelheim Investigational Site

Addison, Illinois, United States

Site Status

1245.48.10019 Boehringer Ingelheim Investigational Site

Arlington Heights, Illinois, United States

Site Status

1245.48.10022 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1245.48.10017 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Site Status

1245.48.10010 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Site Status

1245.48.10036 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

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1245.48.10005 Boehringer Ingelheim Investigational Site

Akron, Ohio, United States

Site Status

1245.48.10004 Boehringer Ingelheim Investigational Site

Kettering, Ohio, United States

Site Status

1245.48.10013 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

Site Status

1245.48.10020 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

1245.48.10029 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Site Status

1245.48.10015 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Site Status

1245.48.10034 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1245.48.10007 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1245.48.10009 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1245.48.10042 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1245.48.10026 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1245.48.10003 Boehringer Ingelheim Investigational Site

Orem, Utah, United States

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1245.48.10023 Boehringer Ingelheim Investigational Site

Port Orchard, Washington, United States

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1245.48.20002 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

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1245.48.20001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

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1245.48.20004 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

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1245.48.20006 Boehringer Ingelheim Investigational Site

Etobicoke, Ontario, Canada

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1245.48.20007 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

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1245.48.20005 Boehringer Ingelheim Investigational Site

Thornhill, Ontario, Canada

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1245.48.20003 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1245.48.42003 Boehringer Ingelheim Investigational Site

Benešov, , Czechia

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1245.48.42005 Boehringer Ingelheim Investigational Site

Brno, , Czechia

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1245.48.42002 Boehringer Ingelheim Investigational Site

Mladá Boleslav, , Czechia

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1245.48.42006 Boehringer Ingelheim Investigational Site

Neratovice, , Czechia

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1245.48.42008 Boehringer Ingelheim Investigational Site

Olomouc, , Czechia

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1245.48.42004 Boehringer Ingelheim Investigational Site

Opočno, , Czechia

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1245.48.42007 Boehringer Ingelheim Investigational Site

Příbram, , Czechia

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1245.48.42001 Boehringer Ingelheim Investigational Site

Slaný, , Czechia

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1245.48.45006 Boehringer Ingelheim Investigational Site

Aalborg, , Denmark

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1245.48.45009 Boehringer Ingelheim Investigational Site

Aarhus C, , Denmark

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1245.48.45002 Boehringer Ingelheim Investigational Site

Elsinore, , Denmark

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1245.48.45008 Boehringer Ingelheim Investigational Site

Hellerup, , Denmark

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1245.48.45010 Boehringer Ingelheim Investigational Site

Hillerød, , Denmark

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1245.48.45003 Boehringer Ingelheim Investigational Site

København NV, , Denmark

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1245.48.45001 Boehringer Ingelheim Investigational Site

Rødovre Municipality, , Denmark

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1245.48.45004 Boehringer Ingelheim Investigational Site

Rødovre Municipality, , Denmark

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1245.48.45005 Boehringer Ingelheim Investigational Site

Vaerløse, , Denmark

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1245.48.45007 Boehringer Ingelheim Investigational Site

Vojens, , Denmark

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1245.48.37203 Boehringer Ingelheim Investigational Site

Pärnu, , Estonia

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1245.48.37201 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1245.48.37202 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1245.48.37204 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1245.48.35802 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

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1245.48.35805 Boehringer Ingelheim Investigational Site

Joensuu, , Finland

Site Status

1245.48.35806 Boehringer Ingelheim Investigational Site

Kouvola, , Finland

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1245.48.35803 Boehringer Ingelheim Investigational Site

Oulu, , Finland

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1245.48.35804 Boehringer Ingelheim Investigational Site

Pori, , Finland

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1245.48.35801 Boehringer Ingelheim Investigational Site

Turku, , Finland

Site Status

1245.48.35807 Boehringer Ingelheim Investigational Site

Turku, , Finland

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1245.48.33004 Boehringer Ingelheim Investigational Site

Angers, , France

Site Status

1245.48.33008 Boehringer Ingelheim Investigational Site

Bourges, , France

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1245.48.33005 Boehringer Ingelheim Investigational Site

Mont-de-Marsan, , France

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1245.48.33001 Boehringer Ingelheim Investigational Site

Nantes, , France

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1245.48.33006 Boehringer Ingelheim Investigational Site

Orthez, , France

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1245.48.33003 Boehringer Ingelheim Investigational Site

Tiercé, , France

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1245.48.33007 Boehringer Ingelheim Investigational Site

Tours, , France

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1245.48.49001 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1245.48.49008 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1245.48.49003 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1245.48.49004 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1245.48.49005 Boehringer Ingelheim Investigational Site

Lüneburg, , Germany

Site Status

1245.48.49002 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1245.48.49010 Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Site Status

1245.48.49009 Boehringer Ingelheim Investigational Site

Pirna, , Germany

Site Status

1245.48.49007 Boehringer Ingelheim Investigational Site

Schkeuditz, , Germany

Site Status

1245.48.49006 Boehringer Ingelheim Investigational Site

Teuchern, , Germany

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1245.48.96003 Boehringer Ingelheim Investigational Site

Baabda, , Lebanon

Site Status

1245.48.96001 Boehringer Ingelheim Investigational Site

Beirut, , Lebanon

Site Status

1245.48.96002 Boehringer Ingelheim Investigational Site

Lebanon, , Lebanon

Site Status

1245.48.31011 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

Site Status

1245.48.31012 Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

Site Status

1245.48.31009 Boehringer Ingelheim Investigational Site

Etten-Leur, , Netherlands

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1245.48.31014 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

Site Status

1245.48.31013 Boehringer Ingelheim Investigational Site

Leiderdorp, , Netherlands

Site Status

1245.48.31003 Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

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1245.48.31016 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

Site Status

1245.48.31006 Boehringer Ingelheim Investigational Site

Soerendonk, , Netherlands

Site Status

1245.48.31008 Boehringer Ingelheim Investigational Site

Spijkenisse, , Netherlands

Site Status

1245.48.31002 Boehringer Ingelheim Investigational Site

Swifterbant, , Netherlands

Site Status

1245.48.31015 Boehringer Ingelheim Investigational Site

Velp, , Netherlands

Site Status

1245.48.31010 Boehringer Ingelheim Investigational Site

Woerden, , Netherlands

Site Status

1245.48.31019 Boehringer Ingelheim Investigational Site

Zijndrecht, , Netherlands

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1245.48.31017 Boehringer Ingelheim Investigational Site

Zoetermeer, , Netherlands

Site Status

1245.48.47009 Boehringer Ingelheim Investigational Site

Ålesund, , Norway

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1245.48.47008 Boehringer Ingelheim Investigational Site

Elverum, , Norway

Site Status

1245.48.47007 Boehringer Ingelheim Investigational Site

Hamar, , Norway

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1245.48.47002 Boehringer Ingelheim Investigational Site

Kløfta, , Norway

Site Status

1245.48.47001 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1245.48.47003 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1245.48.47004 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1245.48.47005 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1245.48.47006 Boehringer Ingelheim Investigational Site

Sørumsand, , Norway

Site Status

1245.48.46002 Boehringer Ingelheim Investigational Site

Härnösand, , Sweden

Site Status

1245.48.46004 Boehringer Ingelheim Investigational Site

Järfälla, , Sweden

Site Status

1245.48.46003 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

1245.48.46007 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

Site Status

1245.48.46006 Boehringer Ingelheim Investigational Site

Skene, , Sweden

Site Status

1245.48.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

Countries

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United States Canada Czechia Denmark Estonia Finland France Germany Lebanon Netherlands Norway Sweden

References

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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.

Reference Type DERIVED
PMID: 38770818 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35472672 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27977392 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25271206 (View on PubMed)

Other Identifiers

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2011-000347-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.48

Identifier Type: -

Identifier Source: org_study_id

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