Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes
2015년 4월 20일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
105
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국
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Arizona
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Green Valley, Arizona, 미국
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Tempe, Arizona, 미국
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Tucson, Arizona, 미국
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California
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Buena Park, California, 미국
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Hawaiian Gardens, California, 미국
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Norwalk, California, 미국
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Paramount, California, 미국
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Rancho Cucamonga, California, 미국
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Sacramento, California, 미국
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San Diego, California, 미국
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Tustin, California, 미국
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Colorado
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Denver, Colorado, 미국
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Florida
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Bradenton, Florida, 미국
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Brooksville, Florida, 미국
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Hallandale Beach, Florida, 미국
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Jupiter, Florida, 미국
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Miami, Florida, 미국
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Orlando, Florida, 미국
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Pembroke Pines, Florida, 미국
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St Petersburg, Florida, 미국
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Tampa, Florida, 미국
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Winter Park, Florida, 미국
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Georgia
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Roswell, Georgia, 미국
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Illinois
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Chicago, Illinois, 미국
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Evergreen Park, Illinois, 미국
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Gurnee, Illinois, 미국
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Indiana
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Avon, Indiana, 미국
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Greenfield, Indiana, 미국
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Kentucky
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Lexington, Kentucky, 미국
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Paducah, Kentucky, 미국
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Maryland
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Baltimore, Maryland, 미국
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Missouri
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Columbia, Missouri, 미국
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Nebraska
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Omaha, Nebraska, 미국
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Nevada
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Las Vegas, Nevada, 미국
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New Jersey
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Margate, New Jersey, 미국
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New Mexico
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Albuquerque, New Mexico, 미국
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New York
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Brooklyn, New York, 미국
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North Carolina
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Calabash, North Carolina, 미국
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Greensboro, North Carolina, 미국
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Lenoir, North Carolina, 미국
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Morehead City, North Carolina, 미국
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Salisbury, North Carolina, 미국
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Wilmington, North Carolina, 미국
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Winston-Salem, North Carolina, 미국
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Ohio
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Centerville, Ohio, 미국
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Cincinnati, Ohio, 미국
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Oklahoma
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Oklahoma City, Oklahoma, 미국
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Pennsylvania
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Downingtown, Pennsylvania, 미국
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Fleetwood, Pennsylvania, 미국
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Reading, Pennsylvania, 미국
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Rhode Island
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Providence, Rhode Island, 미국
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South Carolina
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Anderson, South Carolina, 미국
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Tennessee
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Chattanooga, Tennessee, 미국
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Kingsport, Tennessee, 미국
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Nashville, Tennessee, 미국
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Texas
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Dallas, Texas, 미국
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Houston, Texas, 미국
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Irving, Texas, 미국
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North Richland Hills, Texas, 미국
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Pearland, Texas, 미국
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San Antonio, Texas, 미국
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Utah
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Salt Lake City, Utah, 미국
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Virginia
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Burke, Virginia, 미국
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Manassas, Virginia, 미국
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Richmond, Virginia, 미국
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Virginia Beach, Virginia, 미국
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Wisconsin
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Wauwatosa, Wisconsin, 미국
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Was male or female and ≥18 years.
- Had type 2 diabetes mellitus with HbA1c of ≥7.5 to ≤9.5% at Screening.
- 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.
- 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.
- 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:
- Had a mean, trough, sitting clinic diastolic blood pressure (DBP) ≥ 100 mm Hg at Day -1.
- Had type 1 or poorly controlled type 2 diabetes mellitus (HbA1c >9.5%) at Screening.
- Was taking or expected to take an excluded medication.
- 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.
- Had clinically significant cardiac conduction defects (for example, 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation).
- Had hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
- Had secondary hypertension of any etiology (e.g., renovascular disease, pheochromocytoma, Cushing's syndrome).
- Had renal dysfunction defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening.
- Had albuminuria defined as >200 mg/g at Screening.
- Had known or suspected unilateral or bilateral renal artery stenosis.
- Had unexplained microhematuria ≥3 RBCs/HPF or macrohematuria at Screening and confirmed on repeat testing.
- 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.
- Had hyperkalemia as defined by central laboratory normal reference range at Screening.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Placebo QD
Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
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실험적: Azilsartan Medoxomil 40 mg QD
Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
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다른 이름들:
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실험적: Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure
기간: Baseline and Week 8
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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.
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Baseline and Week 8
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Glycosylated Hemoglobin (HbA1c)
기간: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure
기간: Baseline and Week 8
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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.
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Baseline and Week 8
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Change From Baseline in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
기간: Baseline and Week 8
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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.
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Baseline and Week 8
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Change From Baseline in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
기간: Baseline and Week 8
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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.
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Baseline and Week 8
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Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
기간: 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.
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Baseline and Week 8
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Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
기간: 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.
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Baseline and Week 8
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Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
기간: 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.
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Baseline and Week 8
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Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
기간: 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.
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Baseline and Week 8
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Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
기간: 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.
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Baseline and Week 8
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Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
기간: 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.
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Baseline and Week 8
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Change From Baseline in the Trough (22 to 24 Hours After Dosing) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
기간: Baseline and Week 8
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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.
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Baseline and Week 8
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Change From Baseline in the Trough (22 to 24 Hours After Dosing) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
기간: 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.
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Baseline and Week 8
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Percentage of Participants Requiring Rescue Glycemic Therapy
기간: 24 Weeks
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Percentage of participants requiring rescue glycemic therapy during study.
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24 Weeks
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Time to First Glycemic Rescue
기간: 24 Weeks
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The time to the first instance of participants requiring glycemic rescue during study.
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24 Weeks
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Change From Baseline in HbA1c
기간: Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20
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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.
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Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20
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Change From Baseline in Fasting Plasma Glucose
기간: Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24
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The change between the fasting plasma glucose value collected at each week indicated relative to baseline.
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Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24
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Change From Baseline to Week 6 and Week 24 in 2h Glucose During Oral Glucose Tolerance Testing (OGTT)
기간: Baseline and Weeks 6 and 24
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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.
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Baseline and Weeks 6 and 24
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Change From Baseline to Week 6 and Week 24 in the Area Under the Plasma Concentration-time Curve (AUC) for Glucose During OGTT
기간: 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.
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Baseline and Weeks 6 and 24
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Change From Baseline to Week 6 and Week 24 in AUC for Insulin During OGTT
기간: 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.
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Baseline and Weeks 6 and 24
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Change From Baseline to Week 6 and Week 24 in AUC for C-peptide During OGTT
기간: 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.
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Baseline and Weeks 6 and 24
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Change From Baseline to Week 6 and Week 24 in AUC for Insulin/Glucose Ratio During OGTT
기간: 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
|
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Change From Baseline to Week 6 and Week 24 in AUC for Glucagon During OGTT
기간: 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.
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Baseline and Weeks 6 and 24
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Director, Clinical Science, Takeda
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 1월 1일
기본 완료 (실제)
2013년 5월 1일
연구 완료 (실제)
2013년 5월 1일
연구 등록 날짜
최초 제출
2011년 12월 18일
QC 기준을 충족하는 최초 제출
2011년 12월 20일
처음 게시됨 (추정)
2011년 12월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 4월 20일
마지막으로 확인됨
2015년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TAK-491_304
- U1111-1125-1197 (레지스트리 식별자: WHO)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .