A RANDOMIZED, PARALLEL-GROUP, OPEN-LABEL, PLACEBO CONTROLLED STUDY OF THE EFFECT OF OAP-189 ON THE PHARMACOKINETICS AND PHARMACODYNAMICS OF METFORMIN IN DIABETIC SUBJECTS.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Number of Participants With Injection Site Reactions
研究概览
简要总结
This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects with type 2 diabetes who are taking metformin for their diabetes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have been diagnosed with type 2 diabetes, with HbA1c level >=7.0% and <=11.0% and a fasting glucose level <=280 mg/dL.
- •Men or women of nonchildbearing potential (WONCBP), aged 18 to 65 years inclusive on study day
- •Body mass index in the range of 27 to 40kg/m² (inclusive) and body weight >=50 kg.
- •Subjects must be otherwise generally healthy, but may be enrolled with a stable chronic illness, if it is well controlled and does not interfere with the primary objective of the study.
- •Subjects must currently be treated for diabetes with metformin alone at a total daily dose of >=1gm (administered QD or BID) and that dose must have been stable for at least 4 weeks before study day
- •Nonsmoker.
排除标准
- •Any significant disease with the exception of diabetes mellitus.
- •Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
- •Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day
- •Any clinically important problems in physical examination results, vitals sign measurements, ECGs, or clinical laboratory test results.
- •Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- •Positive findings of urine drug screen
- •Use of any investigational or non-permitted prescription drug within 30 days before investigational product administration.
研究组 & 干预措施
OAP-189
干预措施: OAP-189 (Drug)
2
干预措施: placebo comparator (Drug)
结局指标
主要结局
Number of Participants With Injection Site Reactions
时间窗: Baseline up to 17 days after last dose of study drug (Day 31)
Injection site reactions included irritation, erythema, pain, hematoma, inflammation.
Number of Participants With Clinically Significant Fasting Glucose Level Abnormalities
时间窗: Baseline up to 17 days after last dose of study drug (Day 31)
Criteria: Blood glucose levels \>15 milligram per deciliter (mg/dL) above ULN or \>15 mg/dL below LLN.
Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
时间窗: Baseline up to 17 days after last dose of study drug (Day 31)
Criteria for clinically significant ECG abnormalities: PR interval \>=220 millisecond (msec) or a change of \>=20 msec from baseline values, QRS interval \>=120 msec, QTc interval \>450 msec (in males) and \>470 msec (in females).
Number of Participants With Clinically Significant Physical Examination Abnormalities
时间窗: Baseline up to 17 days after last dose of study drug (Day 31)
Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), heart, lungs, abdomen, extremities, neurological function, back and lymph nodes. Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.
Change From Baseline in Predose Fasting Glucose Levels at Day 8
时间窗: Baseline, Day 8
Fasting glucose levels were determined before administration of OAP-189 using a glucometer.
Number of Participants With Clinically Significant Vital Signs Abnormalities
时间窗: Baseline up to 17 days after last dose of study drug (Day 31)
Criteria for clinically significant vital sign abnormalities: sitting systolic blood pressure (SBP) of (greater than equal to) \>=160 millimeter of mercury (mmHg), (less than equal to) \<=90 mmHg, \>=20 mmHg increase and decrease from baseline; sitting diastolic blood pressure (DBP) of \>=100 mmHg, \<=50 mmHg, \>=15 mmHg increase and decrease from baseline; heart rate of \>=120 beats per minute (bpm), \<=45 bpm, (greater than) \>15 bpm increase and decrease from baseline, orthostatic SBP: decrease of \>=20 mm Hg from sitting value, orthostatic DBP: decrease of \>=20 mm Hg from sitting value, orthostatic heart rate: increase of \>=30 bpm from sitting value, oral temperature of (less than) \<35 or \>38.3 degree celsius, respiratory rate of \<10 or \>25 breaths per minute, weight: maximum increase or decrease of \>=7 percent (%) from baseline.
Number of Participants With Clinically Significant Laboratory Abnormalities
时间窗: Baseline up to 17 days after last dose of study drug (Day 31)
Hematocrit, haemoglobin: decrease of \>=0.05 L/L and \>=20 g/L from baseline respectively, WBC count:\<3\*10\^9 /L, neutrophils: \<1.5\*10\^9 /L, platelet count: \<100\*10\^9 /L, eosinophil: \<0.5\*10\^9 /L; prothrombin time, partial thromboplastin time \>1.5\*upper limit of normal (ULN); sodium:\>5 mmol/L above ULN or below lower limit of normal(LLN), potassium \>0.5 mmol/L above ULN or below LLN, creatinine \>1.36\*ULN, blood urea nitrogen \>1.5\*ULN, glucose (fasting) \>0.83 mmol/L above ULN or below LLN, glucose (non-fasting) \>5 mmol/L above ULN or \>0.56 below LLN, calcium, magnesium: Change of \>=0.25 and \>=0.21 mmol/L from baseline respectively, phosphorus \>0.162 mmol/L above ULN or below LLN, total protein, albumin, uric acid: change of \>=20g/L, \>=10 g/L, \>0.119 mmol/L from baseline respectively, creatinine kinase \>3\*ULN, total cholesterol \>7.77 mmol/L, triglycerides \>3.39 mmol/L: AST, ALT, total bilirubin \>2\*ULN, alkaline phosphatase \>1.5\*ULN, alpha-glumatyl transferase, lactate dehydrogenase \>3\*ULN.
Number of Participants With Hypoglycaemia
时间窗: Baseline up to 17 days after last dose of study drug (Day 31)
Hypoglycaemia is a condition characterized by abnormally low blood glucose (blood sugar) levels, usually \<=50 mg/dL.
Number of Participants With Drug-Induced Liver Injury
时间窗: Baseline up to 17 days after last dose of study drug (Day 31)
Criteria for drug induced liver injury: Levels of aspartate transaminase (AST) or alanine transaminase (ALT) should be \>= 3 times ULN concurrent with a total bilirubin of \>=2 times ULN with no evidence of hemolysis and an alkaline phosphatase should be \<=2 times ULN.
Change From Baseline in Predose Fasting Glucose Levels at Day 15
时间窗: Baseline, Day 15
Fasting glucose levels were determined before administration of OAP-189 using a glucometer.
次要结局
未报告次要终点