NCT02091362已完成2 期
The Effect of LY2409021 on Blood Pressure and Pulse Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 18
- 主要终点
- Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure
研究概览
简要总结
The main purpose of the trial is to determine the effect of a study drug known as LY2409021 on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when compared to placebo. The study has two periods. Each participant will receive LY2409021 or placebo in each period. At least 4 weeks will pass between periods. The study will last about 23 weeks for each participant. Participants may remain on stable dose metformin, as prescribed by their personal physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes mellitus (according to the World Health Organization diagnostic criteria) and use diet and exercise alone or in combination with a stable dose of metformin ( >/=1000 mg/day [or <1000 mg, if documented intolerance to 1000 mg or higher dosages] immediate-release metformin or extended-release metformin for at least 2 months before screening).
- •Have glycated hemoglobin (HbA1c) values >/=6.5% and </=8.5%, as determined by the central laboratory at screening.
- •Have mean blood pressures >90/60 millimeters of mercury (mm Hg) and <140/90 mm Hg at screening.
- •If being treated for hypertension, are taking 3 or fewer antihypertensive medications and have been taking stable doses of the same medications for at least 1 month before screening.
- •Stable body weights (±5%) for >/=3 months before screening.
- •Body mass indexes >/=20 kilograms/meters squared (kg/m²) and <40 kg/m².
- •In the investigator's opinion, are well motivated, capable, and willing to:
- •Reliably administer the oral study drug once daily;
- •Maintain a study diary;
- •Perform self-monitored blood glucose testing; and
- •Wear an ambulatory blood pressure monitoring device for at least 24 hours (on multiple occasions).
- •Are women not of child-bearing potential due to:
- •Surgical sterilization, hysterectomy, or bilateral oophorectomy (at least 6 weeks postsurgery) or tubal ligation (confirmed by medical history); or
- •Menopause. Women with an intact uterus are deemed menopausal if they have a cessation of menses for at least 1 year with follicle stimulating hormone >40 milli-international units per milliliter (mIU/mL), are not taking hormones or oral contraceptives within 1 year, and are otherwise healthy.
- •Males who are sexually active and/or have partners of child-bearing age must use reliable methods of birth control during the study and until 3 months after the last doses of study medication. These requirements do not apply if a participant or his partner has been surgically sterilized or is not between menarche and 1 year postmenopausal.
排除标准
- •Have severe gastrointestinal disease that may significantly affect gastric emptying or motility.
- •Previous histories or active diagnoses of pancreatitis.
- •Acute or chronic hepatitis, signs or symptoms of any other liver disease, or alanine aminotransferase (ALT) level greater than 2.5 times the upper limit of normal (ULN).
- •Elevated total bilirubin (greater than 2 times ULN), clinically suspicious signs or symptoms of cirrhosis or history of cirrhosis.
- •Mean resting pulse rate (PR) less than 60 beats per minute (bpm) or greater than 100 bpm.
- •Current diagnosis or personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia, or Von Hippel-Lindau disease.
研究组 & 干预措施
Placebo
Placebo Comparator
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods.
干预措施: Metformin (Drug)
LY2409021
Experimental
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods.
干预措施: LY2409021 (Drug)
LY2409021
Experimental
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods.
干预措施: Metformin (Drug)
结局指标
主要结局
Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure
时间窗: Baseline, 6 Weeks
Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).
次要结局
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, 6 Weeks)
- Population Pharmacokinetics: Apparent Clearance of LY2409021(Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.)
- Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021(Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.)
- Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure(Baseline, 6 Weeks)
- Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate(Baseline, 6 Weeks)
- Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures(Baseline, 6 Weeks)
- Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)(Baseline, 6 Weeks)
研究者
研究点 (18)
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