NCT01149421已完成2 期
The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients 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
- 755
- 试验地点
- 1
- 主要终点
- Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)
研究概览
简要总结
The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening
- •Glycosylated hemoglobin (HbA1c) value ≥7% and ≤9.5% at screening
- •Mean blood pressure >90/60 millimeters of mercury (mmHg) and <140/90 mmHg at screening
- •If treated for hypertension, are taking 3 or less antihypertensive medications and have been taking these medications for at least 1 month prior to screening
- •Stable weight for 3 months prior to screening
- •Body mass index (BMI) greater than or equal to 23 kilogram-meter squared (kg/m^2)
- •Willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions
- •Women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control
- •Male participants must use a reliable method of birth control
排除标准
- •Myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure Class III or IV at screening
- •Ongoing or history of frequent intermittent tachyarrhythmia
- •Resting heart rate <60 beats per minute (bpm) or >100 bpm at screening
- •Work rotating shifts or work during the hours of 2200 to 0700
- •Chronic insulin therapy
- •Use of a glucagon-like peptide 1 (GLP-1) receptor agonist within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening
- •Nondominant arm circumference >42 centimeter (cm)
- •Use of drugs to promote weight loss
- •Chronic use of systemic steroids
- •Gastric emptying abnormality or bariatric surgery
- •Hepatitis, other liver disease, or alanine transaminase (ALT) >3 times the upper limit of normal
- •Acute or chronic pancreatitis
- •Severe renal impairment
- •Active autoimmune disease or uncontrolled endocrine abnormality
- •Self or family history of thyroid cancer, medullary C-cell hyperplasia, or type 2A or 2B multiple endocrine neoplasia
- •Calcitonin value greater than or equal to 20 picograms per milliliter (pg/ml) at screening
- •Transplanted organ except corneal transplants
- •Active or untreated cancer or in remission <5 years, except skin, in situ cervical, or prostate cancer
- •Sickle-cell disease, hemolytic anemia, or another hematological condition that may interfere with HbA1c testing
研究组 & 干预措施
1.5 milligram (mg) LY2189265
Experimental
LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)
干预措施: LY2189265 (Drug)
0.75 milligram (mg) LY2189265
Experimental
LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW)
干预措施: LY2189265 (Drug)
Placebo
Placebo Comparator
Placebo: subcutaneous (SC), once weekly (QW)
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)
时间窗: Baseline, 16 weeks
Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.
次要结局
- Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)(Baseline, 16 and 26 weeks)
- Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%(Baseline and 16 and 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)(Baseline, 16 and 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)(Baseline, 16 and 26 weeks)
- Change From Baseline to 16 and 26 Weeks on Serum Calcitonin(Baseline, 16 and 26 weeks)
- Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)(Baseline, 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)(Baseline, 16 and 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)(Baseline, 16 and 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)(Baseline, 16 and 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure(Baseline, 16 and 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure(Baseline, 16 and 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)(Baseline, 16 and 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)(Baseline, 16 and 26 weeks)
- Rate of Hypoglycemic Episodes(Baseline, 16 and 26 weeks)
- Number of Participants With Treatment Emergent Adverse Events at 26 Weeks(Baseline through 26 weeks)
- Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)(Baseline, 16 weeks)
- Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval(Baseline, 16 and 26 weeks)
- Anti-LY2189265 Antibodies(Baseline, 16, 26, and 30 weeks)
- Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)(Baseline, 16 and 26 weeks)
- Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks(Baseline through 26 weeks)
- Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC)(4, 8, 12, 16, and 26 weeks)
- Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes(Baseline, 16 and 26 weeks)
- Number of Events of Adjudicated Pancreatitis up to 26 Weeks(Baseline through 26 weeks)
- Change From Baseline to 16 and 26 Weeks in Body Weight(Baseline, 16 and 26 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients with Type 2 Diabetes Mellitus - GBDMedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitusType 2 Diabetes MellitusEUCTR2010-019581-82-DEEli Lilly & Company693
已完成
2 期
A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 DiabetesCTRI/2010/091/001444Eli Lilly683
进行中（未招募）
不适用
To know how LY2189265 affects (that is, increases, decreases or no change) blood pressure and heart rate in patients with type 2 diabetes mellitusType 2 Diabetes MellitusEUCTR2010-019581-82-DKEli Lilly & Company693
进行中（未招募）
不适用
To know how LY2189265 affects (that is, increases, decreases or no change) blood pressure and heart rate in patients with type 2 diabetes mellitusMedDRA version: 14.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2010-019581-82-CZEli Lilly & Company693
已完成
2 期
A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT02091362Eli Lilly and Company270