NCT03985293已完成2 期
A 16-WEEK, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWICE DAILY PF-06882961 ADMINISTRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN OR DIET AND EXERCISE
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
- 412
- 试验地点
- 81
- 主要终点
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16
研究概览
简要总结
This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2DM who are treated with metformin and/or diet and exercise
- •HbA1c greater than or equal to 7% and less than or equal to 10.5%
- •Total body weight >50 kg (110 lb) with BMI 24.5 to 45.4 kg/m^2
排除标准
- •Any condition possibly affecting drug absorption
- •Diagnosis of Type 1 diabetes
- •History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening
- •Any malignancy not considered cured
- •Personal or family history of MTC or MEN2, or participants with suspected MTC
- •Acute pancreatitis or history of chronic pancreatitis
- •Symptomatic gallbladder disease
- •Known medical history of active proliferative retinopathy and/or macular edema
- •Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
- •Known history of HIV
- •Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
- •Clinically relevant ECG abnormalities
- •Positive urine drug test
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PF-06882961 2.5 milligrams (mg)
Experimental
干预措施: PF-06882961 (Drug)
PF-06882961 10 mg
Experimental
干预措施: PF-06882961 (Drug)
PF-06882961 40 mg
Experimental
Participants will be titrated up to 2 weeks to reach desired dose level
干预措施: PF-06882961 (Drug)
PF-06882961 80 mg
Experimental
Participants will be titrated up to 4 weeks to reach desired dose level
干预措施: PF-06882961 (Drug)
PF-06882961 120 mg
Experimental
Participants will be titrated up to 6 weeks to reach desired dose level
干预措施: PF-06882961 (Drug)
结局指标
主要结局
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16
时间窗: Baseline, Week 16
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
次要结局
- Change From Baseline in Fasting Plasma Glucose at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels(Baseline, Week 16)
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2(Baseline, Week 2)
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4(Baseline, Week 4)
- Change From Baseline in Fasting Plasma Glucose at Week 2(Baseline, Week 2)
- Change From Baseline in Fasting Plasma Glucose at Week 6(Baseline, Week 6)
- Change From Baseline in Body Weight at Week 2(Baseline, Week 2)
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6(Baseline, Week 6)
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12(Baseline, Week 12)
- Change From Baseline in Fasting Plasma Glucose at Week 8(Baseline, Week 8)
- Change From Baseline in Body Weight at Week 6(Baseline, Week 6)
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8(Baseline, Week 8)
- Change From Baseline in Fasting Plasma Glucose at Week 4(Baseline, Week 4)
- Change From Baseline in Fasting Plasma Glucose at Week 12(Baseline, Week 12)
- Change From Baseline in Body Weight at Week 4(Baseline, Week 4)
- Change From Baseline in Body Weight at Week 16(Baseline, Week 16)
- Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])(Baseline up to Week 21)
- Change From Baseline in Body Weight at Week 8(Baseline, Week 8)
- Change From Baseline in Body Weight at Week 12(Baseline, Week 12)
- Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality(Baseline Through Week 21)
- Number of Participants With Treatment Emergent ECG Abnormalities(Baseline Through Week 21)
- Number of Participants With Treatment Emergent Vital Signs Abnormalities(Baseline through Week 21)
研究者
研究点 (81)
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