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Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes

20 aprile 2015 aggiornato da: Takeda

A Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy and Safety of TAK-491 Compared to Placebo When Used in Combination With Metformin in Subjects With Hypertension and Type 2 Diabetes

The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study included a Screening Period of up to 4 weeks, which coincided with a 2-week single-blind, placebo Run-in Period, a 24 week Treatment Period, and a 2-week Follow-up Period. The duration of the study was approximately 30 weeks. The planned number of participants (n=450) was not reached; actual enrollment consisted of 105 particpants. Due to low enrollment this study was terminated early by Takeda.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

105

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti
    • Arizona
      • Green Valley, Arizona, Stati Uniti
      • Tempe, Arizona, Stati Uniti
      • Tucson, Arizona, Stati Uniti
    • California
      • Buena Park, California, Stati Uniti
      • Hawaiian Gardens, California, Stati Uniti
      • Norwalk, California, Stati Uniti
      • Paramount, California, Stati Uniti
      • Rancho Cucamonga, California, Stati Uniti
      • Sacramento, California, Stati Uniti
      • San Diego, California, Stati Uniti
      • Tustin, California, Stati Uniti
    • Colorado
      • Denver, Colorado, Stati Uniti
    • Florida
      • Bradenton, Florida, Stati Uniti
      • Brooksville, Florida, Stati Uniti
      • Hallandale Beach, Florida, Stati Uniti
      • Jupiter, Florida, Stati Uniti
      • Miami, Florida, Stati Uniti
      • Orlando, Florida, Stati Uniti
      • Pembroke Pines, Florida, Stati Uniti
      • St Petersburg, Florida, Stati Uniti
      • Tampa, Florida, Stati Uniti
      • Winter Park, Florida, Stati Uniti
    • Georgia
      • Roswell, Georgia, Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti
      • Evergreen Park, Illinois, Stati Uniti
      • Gurnee, Illinois, Stati Uniti
    • Indiana
      • Avon, Indiana, Stati Uniti
      • Greenfield, Indiana, Stati Uniti
    • Kentucky
      • Lexington, Kentucky, Stati Uniti
      • Paducah, Kentucky, Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti
    • Missouri
      • Columbia, Missouri, Stati Uniti
    • Nebraska
      • Omaha, Nebraska, Stati Uniti
    • Nevada
      • Las Vegas, Nevada, Stati Uniti
    • New Jersey
      • Margate, New Jersey, Stati Uniti
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti
    • New York
      • Brooklyn, New York, Stati Uniti
    • North Carolina
      • Calabash, North Carolina, Stati Uniti
      • Greensboro, North Carolina, Stati Uniti
      • Lenoir, North Carolina, Stati Uniti
      • Morehead City, North Carolina, Stati Uniti
      • Salisbury, North Carolina, Stati Uniti
      • Wilmington, North Carolina, Stati Uniti
      • Winston-Salem, North Carolina, Stati Uniti
    • Ohio
      • Centerville, Ohio, Stati Uniti
      • Cincinnati, Ohio, Stati Uniti
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti
    • Pennsylvania
      • Downingtown, Pennsylvania, Stati Uniti
      • Fleetwood, Pennsylvania, Stati Uniti
      • Reading, Pennsylvania, Stati Uniti
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti
    • South Carolina
      • Anderson, South Carolina, Stati Uniti
    • Tennessee
      • Chattanooga, Tennessee, Stati Uniti
      • Kingsport, Tennessee, Stati Uniti
      • Nashville, Tennessee, Stati Uniti
    • Texas
      • Dallas, Texas, Stati Uniti
      • Houston, Texas, Stati Uniti
      • Irving, Texas, Stati Uniti
      • North Richland Hills, Texas, Stati Uniti
      • Pearland, Texas, Stati Uniti
      • San Antonio, Texas, Stati Uniti
    • Utah
      • Salt Lake City, Utah, Stati Uniti
    • Virginia
      • Burke, Virginia, Stati Uniti
      • Manassas, Virginia, Stati Uniti
      • Richmond, Virginia, Stati Uniti
      • Virginia Beach, Virginia, Stati Uniti
    • Wisconsin
      • Wauwatosa, Wisconsin, Stati Uniti

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Was male or female and ≥18 years.
  2. Had type 2 diabetes mellitus with HbA1c of ≥7.5 to ≤9.5% at Screening.
  3. Was treated with metformin alone (no treatment with any antidiabetic agents other than metformin within the 3 months prior to Screening) and was experiencing inadequate glycemic control. The participant should have received metformin monotherapy for ≥8 weeks prior to Screening at a stable dose ≥1500 mg). Participants with a maximum tolerated dose (MTD) that was documented to be less than 1500 mg of metformin could also be enrolled if this dose had been stable for 8 weeks prior to Screening.
  4. Was treated with antihypertensive therapy and had a mean, trough, sitting clinic systolic blood pressure (SBP) ≥135 and < 160 mm Hg on Day -1 (after washout of prior antihypertensive therapy) or the participant had not received antihypertensive treatment within 28 days before Screening and had a mean sitting clinic SBP ≥135 and < 160 mm Hg at the Screening Visit and on Day -1.
  5. Had clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or results that were deemed not clinically significant in this participant population for inclusion in this study, by the investigator.

Exclusion Criteria:

  1. Had a mean, trough, sitting clinic diastolic blood pressure (DBP) ≥ 100 mm Hg at Day -1.
  2. Had type 1 or poorly controlled type 2 diabetes mellitus (HbA1c >9.5%) at Screening.
  3. Was taking or expected to take an excluded medication.
  4. Had a history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
  5. Had clinically significant cardiac conduction defects (for example, 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation).
  6. Had hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
  7. Had secondary hypertension of any etiology (e.g., renovascular disease, pheochromocytoma, Cushing's syndrome).
  8. Had renal dysfunction defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening.
  9. Had albuminuria defined as >200 mg/g at Screening.
  10. Had known or suspected unilateral or bilateral renal artery stenosis.
  11. Had unexplained microhematuria ≥3 RBCs/HPF or macrohematuria at Screening and confirmed on repeat testing.
  12. Treatment with antidiabetic agents (sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides, thiazolidinediones (TZDs), and/or insulin) other than metformin during the 3 months prior to Screening.
  13. Had hyperkalemia as defined by central laboratory normal reference range at Screening.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo QD
Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
Droga: Placebo
Sperimentale: Azilsartan Medoxomil 40 mg QD
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
Droga: Azilsartan medoxomil
Altri nomi:
  • TAK-491
Sperimentale: Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
Droga: Azilsartan medoxomil
Altri nomi:
  • TAK-491

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure
Lasso di tempo: Baseline and Week 8
The change in trough systolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
Baseline and Week 8

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Lasso di tempo: Baseline and Week 24
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.
Baseline and Week 24
Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure
Lasso di tempo: Baseline and Week 8
The change in trough diastolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.
Baseline and Week 8
Change From Baseline in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Baseline and Week 8
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Baseline and Week 8
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in daytime (6am to 10pm) mean systolic blood pressure measured week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Baseline and Week 8
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Baseline and Week 8
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Baseline and Week 8
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Baseline and Week 8
Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.
Baseline and Week 8
Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.
Baseline and Week 8
Change From Baseline in the Trough (22 to 24 Hours After Dosing) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in trough systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Baseline and Week 8
Change From Baseline in the Trough (22 to 24 Hours After Dosing) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Lasso di tempo: Baseline and Week 8
The change in trough diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Baseline and Week 8
Percentage of Participants Requiring Rescue Glycemic Therapy
Lasso di tempo: 24 Weeks
Percentage of participants requiring rescue glycemic therapy during study.
24 Weeks
Time to First Glycemic Rescue
Lasso di tempo: 24 Weeks
The time to the first instance of participants requiring glycemic rescue during study.
24 Weeks
Change From Baseline in HbA1c
Lasso di tempo: Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.
Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20
Change From Baseline in Fasting Plasma Glucose
Lasso di tempo: Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24
The change between the fasting plasma glucose value collected at each week indicated relative to baseline.
Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Change From Baseline to Week 6 and Week 24 in 2h Glucose During Oral Glucose Tolerance Testing (OGTT)
Lasso di tempo: Baseline and Weeks 6 and 24
The change between the glucose value collected at weeks 6 and 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in the Area Under the Plasma Concentration-time Curve (AUC) for Glucose During OGTT
Lasso di tempo: Baseline and Weeks 6 and 24
The change between the AUC for glucose at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for Insulin During OGTT
Lasso di tempo: Baseline and Weeks 6 and 24
The change between the AUC for insulin at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for C-peptide During OGTT
Lasso di tempo: Baseline and Weeks 6 and 24
The change between the AUC for C-peptide at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for Insulin/Glucose Ratio During OGTT
Lasso di tempo: Baseline and Weeks 6 and 24
The change between the AUC for insulin/glucose ratio at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for Glucagon During OGTT
Lasso di tempo: Baseline and Weeks 6 and 24
The change between the AUC for glucagon at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Baseline and Weeks 6 and 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Takeda

Investigatori

  • Direttore dello studio: Director, Clinical Science, Takeda

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2012

Completamento primario (Effettivo)

1 maggio 2013

Completamento dello studio (Effettivo)

1 maggio 2013

Date di iscrizione allo studio

Primo inviato

18 dicembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

20 dicembre 2011

Primo Inserito (Stima)

21 dicembre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 maggio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 aprile 2015

Ultimo verificato

1 aprile 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TAK-491_304
  • U1111-1125-1197 (Identificatore di registro: WHO)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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