NCT02554877已完成2 期
A 12-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-06291874 Administration In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 206
- 试验地点
- 37
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo
研究概览
简要总结
The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM
详细描述
This will be a randomized, double blind, stratified, placebo controlled, parallel group study conducted in T2DM subjects receiving background metformin therapy. Subjects will complete screening procedures to determine eligibility, followed by an 8 week metformin stabilization period prior to randomization. In addition, subjects taking other OADs, in combination with metformin, will undergo a washout during this period, in which non metformin OAD medications will be temporarily discontinued for the duration of the trial. Following confirmation of study eligibility criteria at randomization, subjects will be stratified into 2 groups based on the use of concomitant statin therapy. Each stratum will be randomized across treatment groups, such that the number of subjects taking concomitant statin therapy and those not taking statin therapy will be approximately balanced across treatment groups.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-childbearing potential females between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the screening visit (V1) with the diagnosis of T2DM;Female subjects who are not of childbearing potential
- •Subjects who have been on a stable dose of metformin either alone or in combination with one additional acceptable OAD
- •HbA1c at the Screen Visit (V1), as assessed by study specific central laboratory, is 7-11% if on metformin monotherapy; is 6.5-9.5% if on dual combination therapy (metformin plus 1)
排除标准
- •Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
- •Fasting plasma glucose levels >270 mg/dL (15.0 mmol/L) at the screening and run in visit, (as assessed by study specific central laboratory) confirmed by a single repeat, if deemed necessary
- •History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class III IV heart failure, or transient ischemic attack within 6 months of screening;
- •Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency
- •Subjects with a creatinine clearance <60 mL/min as determined by the Cockcroft Gault equation (listed below) using serum creatinine measured at screening, confirmed via a single repeat, if deemed necessary
- •Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies
- •Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >105 mm Hg after at least a 5 minute rest. Blood pressure determined as the mean of triplicate measurements collected with approximately 2 minutes of rest between measurements
- •Screening supine 12 lead ECG demonstrating a corrected QT (QTc) >470 msec; or a QRS interval >120 msec. If QTc exceeds 470 msec or QRS exceeds 120 msec, the ECG may be repeated 2 more times with an interval of 2-4 minutes between each measurement and the mean of the 3 values used to determine the subject's eligibility
- •Subjects with an arm circumference >52 cm measured at the midpoint of the length of the upper arm;
- •History (within the last 6 months) of regular alcohol consumption exceeding 14 drinks per week for men and 7 drinks a week for women. (1 drink = 5 ounces of wine (150 mL) or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor);
- •Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;
- •Subjects with a known hypersensitivity or intolerance to a glucagon receptor antagonist, or known prior participation in a trial involving PF 06291874;
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PF-06291874, 30 mg
Experimental
干预措施: PF-06291874 (Drug)
PF-06291874, 60 mg
Experimental
干预措施: PF-06291874 (Drug)
PF-06291874, 100 mg
Experimental
干预措施: PF-06291874 (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo
时间窗: Baseline, Week 12
HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.
次要结局
- Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8(Baseline, Weeks 2, 4, 8)
- Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria(Baseline up to Day 98)
- Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12(Baseline, Weeks 2, 4, 8 and 12)
- Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.(Week 12)
- Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12(Baseline, Weeks 2, 4, 8 and 12)
- Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12(Baseline, Weeks 2,4,8 and 12)
- Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria(Baseline up to Day 98)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).(Baseline up to Day 119)
- Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12(Baseline, Weeks 2, 4, 8 and 12)
- Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.(Baseline, Weeks 2, 4, 8 and 12)
- Number of Participants With Laboratory Test Abnormalities(Baseline up to 98 days)
- Percent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12(Baseline, Weeks 2, 4, 8 and 12)
- Percent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12(Baseline, Weeks 2, 4, 8 and 12)
研究者
研究点 (37)
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