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Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03887416
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
LM Diagnósticos S.L.

Brief Summary:

Centres: Three university hospitals and the primary care centres in their area in Madrid (Clínico San Carlos, La Paz, 12 de Octubre) Type of study: Randomized, multicentric, placebo-controlled, single-blind pilot study Main outcome: Nighttime blood pressure in type 2 diabetic patients Objective: To investigate the effect of the addition of 10 mg daily of dapagliflozin to the treatment of diabetic patients compared to the addition of placebo on the change in nighttime blood pressure (measured by ABPM) over 12 weeks among patients withalbuminuria levels ≥ 30 and < 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2..

Patients: 225 patients with a previous diagnosis of type 2 diabetes and eGFR> 30mL/min x1,73m2, office BP above 140/70 mmHg, HbA1C 7.5-10%, albuminuria levels between 30 mg/g creatinine and 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2.

Intervention: 10 mg once daily of dapagliflozin or placebo resembling dapagliflozin.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Drug: Dapagliflozin 10 MG Oral Tablet [Farxiga] Drug: Placebo Oral Tablet Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Type of study: Randomized, multicentric, placebo-controlled, single-blind pilot study.

Primary Objective: To investigate the effect of the addition of 10 mg daily of dapagliflozin to the treatment of diabetic patients compared to the addition of placebo on the change in nighttime blood pressure (measured by ABPM) over 12 weeks among patients with albuminuria levels ≥ 30 and < 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2.

Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes
Actual Study Start Date : April 12, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dapagliflozin

The investigational medicinal product (IMP) is Dapagliflozin 10 MG Oral Tablet [Farxiga] given once daily (film coated tablets, oral use).

Dapagliflozin 10 MG Oral Tablet [Farxiga] will be administered through out the planned intervention period of the study (12 weeks).

Dosage form and strength: 10 mg, Green, plain, diamond shaped, film coated tablet (orally)

Drug: Dapagliflozin 10 MG Oral Tablet [Farxiga]

The investigational medicinal product (IMP) is dapagliflozin10 mg given once daily (film coated tablets, oral use).

Dapagliflozin will be administered through out the planned intervention period of the study (12 weeks).

Dosage form and strength: 10 mg, Green, plain, diamond shaped, film coated tablet (orally)

Other Name: Dapagliflozin

Placebo Comparator: Placebo matching dapagliflozin

The comparator will be placebo oral tablet matching dapagliflozin 10 mg. Placebo will be administered through out the planned intervention period of the study (12 weeks).

Dosage form and strength: Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient

Drug: Placebo Oral Tablet

The comparator will be placebo oral tablet matching dapagliflozin 10 mg. Placebo will be administered through out the planned intervention period of the study (12 weeks).

Dosage form and strength: Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient

Other Name: Placebo




Primary Outcome Measures :
  1. Changes in nighttime blood pressure [ Time Frame: 12 weeks ]
    Changes in mean nighttime blood pressure (systolic and diastolic) between baseline and last visit (units: mmHg)


Secondary Outcome Measures :
  1. Changes in office blood pressure. Both systolic and diastolic blood pressure will be assessed [ Time Frame: 12 weeks ]
    Changes in office blood pressure. Both systolic and diastolic blood pressure will be assessed (units: mmHg)

  2. Changes in albuminuria [ Time Frame: 12 weeks ]
    Changes in albuminuria (units:mg/g creatinine)

  3. Changes in HBA1C [ Time Frame: 12 weeks ]
    Changes in HBA1C (units: %)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with a previous diagnosis of type 2 diabetes and

  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min x1.73m2and
  • Diagnosis of essential hypertension established at least one year before inclusion visit and suboptimal BP control (office BP above 140/70 mmHg)
  • HbA1C 7.5-10%
  • Albuminuria levels ≥ 30 mg/g of creatinine

Exclusion Criteria:

  • Age < 18 years old or ≥ 75 years old.
  • Women of childbearing potential. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • Type 1 diabetes
  • Albuminuria above 3000 mg/g of creatinine
  • Established cardiovascular disease (stable heart failure, peripheral arterial disease or myocardial infarction or stroke within the previous 6 months)
  • Intolerance to dapagliflozin
  • On treatment with loop diuretic
  • On treatment with SGLT2 inhibitors.
  • On treatment with pioglitazone.
  • Patients diagnosed of hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
  • Patients who routinely work during nightime (period between 11.00 p.m. and 7.00 a.m.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887416


Contacts
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Contact: Luis M Ruilope Urioste 629175770 ruilope@icloud.com

Locations
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Spain
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: José A García Donaire         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Julián M Segura de la Morena         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Aquilino Sánchez         
Sponsors and Collaborators
LM Diagnósticos S.L.
AstraZeneca
Investigators
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Study Director: Luis M Ruilope Urioste Hospital Universitario 12 de Octubre de Madrid
  Study Documents (Full-Text)

Documents provided by LM Diagnósticos S.L.:

Publications:
Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, Amann M, Anderson HR, Andrews KG, Aryee M, Atkinson C, Bacchus LJ, Bahalim AN, Balakrishnan K, Balmes J, Barker-Collo S, Baxter A, Bell ML, Blore JD, Blyth F, Bonner C, Borges G, Bourne R, Boussinesq M, Brauer M, Brooks P, Bruce NG, Brunekreef B, Bryan-Hancock C, Bucello C, Buchbinder R, Bull F, Burnett RT, Byers TE, Calabria B, Carapetis J, Carnahan E, Chafe Z, Charlson F, Chen H, Chen JS, Cheng AT, Child JC, Cohen A, Colson KE, Cowie BC, Darby S, Darling S, Davis A, Degenhardt L, Dentener F, Des Jarlais DC, Devries K, Dherani M, Ding EL, Dorsey ER, Driscoll T, Edmond K, Ali SE, Engell RE, Erwin PJ, Fahimi S, Falder G, Farzadfar F, Ferrari A, Finucane MM, Flaxman S, Fowkes FG, Freedman G, Freeman MK, Gakidou E, Ghosh S, Giovannucci E, Gmel G, Graham K, Grainger R, Grant B, Gunnell D, Gutierrez HR, Hall W, Hoek HW, Hogan A, Hosgood HD 3rd, Hoy D, Hu H, Hubbell BJ, Hutchings SJ, Ibeanusi SE, Jacklyn GL, Jasrasaria R, Jonas JB, Kan H, Kanis JA, Kassebaum N, Kawakami N, Khang YH, Khatibzadeh S, Khoo JP, Kok C, Laden F, Lalloo R, Lan Q, Lathlean T, Leasher JL, Leigh J, Li Y, Lin JK, Lipshultz SE, London S, Lozano R, Lu Y, Mak J, Malekzadeh R, Mallinger L, Marcenes W, March L, Marks R, Martin R, McGale P, McGrath J, Mehta S, Mensah GA, Merriman TR, Micha R, Michaud C, Mishra V, Mohd Hanafiah K, Mokdad AA, Morawska L, Mozaffarian D, Murphy T, Naghavi M, Neal B, Nelson PK, Nolla JM, Norman R, Olives C, Omer SB, Orchard J, Osborne R, Ostro B, Page A, Pandey KD, Parry CD, Passmore E, Patra J, Pearce N, Pelizzari PM, Petzold M, Phillips MR, Pope D, Pope CA 3rd, Powles J, Rao M, Razavi H, Rehfuess EA, Rehm JT, Ritz B, Rivara FP, Roberts T, Robinson C, Rodriguez-Portales JA, Romieu I, Room R, Rosenfeld LC, Roy A, Rushton L, Salomon JA, Sampson U, Sanchez-Riera L, Sanman E, Sapkota A, Seedat S, Shi P, Shield K, Shivakoti R, Singh GM, Sleet DA, Smith E, Smith KR, Stapelberg NJ, Steenland K, Stöckl H, Stovner LJ, Straif K, Straney L, Thurston GD, Tran JH, Van Dingenen R, van Donkelaar A, Veerman JL, Vijayakumar L, Weintraub R, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams W, Wilson N, Woolf AD, Yip P, Zielinski JM, Lopez AD, Murray CJ, Ezzati M, AlMazroa MA, Memish ZA. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2224-60. doi: 10.1016/S0140-6736(12)61766-8. Erratum in: Lancet. 2013 Apr 13;381(9874):1276. Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].
Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Böhm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F, Redon J, Dominiczak A, Narkiewicz K, Nilsson PM, Burnier M, Viigimaa M, Ambrosioni E, Caufield M, Coca A, Olsen MH, Schmieder RE, Tsioufis C, van de Borne P, Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S, Clement DL, Coca A, Gillebert TC, Tendera M, Rosei EA, Ambrosioni E, Anker SD, Bauersachs J, Hitij JB, Caulfield M, De Buyzere M, De Geest S, Derumeaux GA, Erdine S, Farsang C, Funck-Brentano C, Gerc V, Germano G, Gielen S, Haller H, Hoes AW, Jordan J, Kahan T, Komajda M, Lovic D, Mahrholdt H, Olsen MH, Ostergren J, Parati G, Perk J, Polonia J, Popescu BA, Reiner Z, Rydén L, Sirenko Y, Stanton A, Struijker-Boudier H, Tsioufis C, van de Borne P, Vlachopoulos C, Volpe M, Wood DA. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J. 2013 Jul;34(28):2159-219. doi: 10.1093/eurheartj/eht151. Epub 2013 Jun 14.

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Responsible Party: LM Diagnósticos S.L.
ClinicalTrials.gov Identifier: NCT03887416     History of Changes
Other Study ID Numbers: DAPA-ESR-16-12460
2017-002125-38 ( EudraCT Number )
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by LM Diagnósticos S.L.:
Nighttime blood pressure
Dapagliflozin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs