NCT00871572已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of LY2409021 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
- 87
- 试验地点
- 1
- 主要终点
- Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
研究概览
简要总结
This drug is being evaluated for possible treatment of type 2 diabetes mellitus. Participation in this study is expected to last up to 18 weeks. A goal of this study is to determine the safety and effectiveness of LY2409021.
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
- 未提供
排除标准
- •Insulin, exenatide, or any diabetic medication other than metformin 3 months prior to screening to control you diabetes,
- •Medications to increase movement in your digestive tract or that slow movement in your digestive tract
- •Over-the-counter drugs or drugs prescribed by your doctor that cause weight loss or high or low blood sugar,
- •Chronically use oral glucocorticoids therapy or have received this type of medication within 8 weeks prior to beginning this study,
- •Class II and III antiarrhythmic agents (commonly used to prevent or relieve an irregular heartbeat),
- •Drugs that damage the liver
- •Fibrates and niacin (both commonly used to treat high cholesterol) more than 1 gram/day (gm/day),
- •Central nervous stimulants, alcohol intake for males that is more than 2 units per day and for females that is more than 1 unit per day [1 unit=12 ounces (oz) or 360 milliliter (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits].
- •You have had one (1) or more cases of uncontrolled diabetes (very high blood sugars) which required hospitalization in the 6 months prior to the screening visit or have a diagnosis of hypoglycemia (low blood sugar) unawareness.
- •You had two (2) or more emergency room visits or were hospitalized for poor control of your diabetes (for example, keto-acidotic episode) in the last 6 months.
- •Participants have a problem with your stomach such that it empties slowly (diabetic gastroparesis) or you have had gastric bypass (bariatric) surgery.
- •Participants have a personal or family history of pancreatic neoplasia.
- •Participants have abnormal lipids (for example triglycerides).
- •Participants have had problems with your heart in the past 6 months, such as a heart attack, chest pain (angina), heart failure, heart bypass operation, angioplasty (a medical procedure to open a narrow or clogged blood vessel of the heart) or stent insertion (a procedure to insert a wire mesh tube to prop open a blood vessel after angioplasty), a heart rhythm problem, or a stroke.
- •Participants have an elevated or uncontrolled blood pressure.
- •Participant's electrocardiogram (ECG, a test that measures the electrical activity of your heart) is outside the normal limits, as determined by the study doctor.
- •Participants have a problem with your kidneys or are on dialysis.
- •Participants have a problem with your pancreas.
- •Participants must not have nor had liver disease (for example, Hepatitis B or C).
- •Participants have cancer, except for skin cancer or have been in remission (the absence of disease activity) from cancer for less than 5 years.
- •Participants have a serious or uncontrolled health problems (other than type 2 diabetes), blood disorders or laboratory tests that in the opinion of the doctor, could interfere with understanding the results of this study. The doctor will let you know if this applies to you.
- •Participants previously completed or withdrew from this study or any other study investigating LY
- •Participants are allergic to the study drug or other related drugs. You cannot be in this study if you are a woman and you possibly could become pregnant during this study.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
LY2409021 10 milligrams (mg)
Experimental
干预措施: LY2409021 (Drug)
LY2409021 30 mg
Experimental
干预措施: LY2409021 (Drug)
LY2409021 60 mg
Experimental
干预措施: LY2409021 (Drug)
结局指标
主要结局
Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 12
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
次要结局
- Change From Baseline to Endpoint for Fasting Triglycerides(Baseline, Week 12)
- Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)(Baseline, Week 12)
- Change From Baseline Values for Fasting Insulin(Baseline, Week 12)
- Change From Baseline to Endpoint for Total Cholesterol(Baseline, Week 12)
- Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)(Baseline, Week 12)
- Change From Baseline Values for Fasting Glucagon(Baseline, Week 12)
- Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)(Baseline, Week 12)
- Change From Baseline for Insulin AUC From OGTT(Baseline, Week 12)
- Change From Baseline to Endpoint for High Density Lipoprotein (HDL)(Baseline, Week 12)
- Change From Baseline Values for Fasting Blood Glucose (FBG)(Baseline, Week 12)
- Change From Baseline to Endpoint for Non-HDL Cholesterol(Baseline, Week 12)
- Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles(Baseline, Week 12)
- Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)(Baseline, Week 12)
- Change From Baseline for C-Peptide AUC From OGTT(Baseline, Week 12)
- Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)(Baseline, Week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of LY2409021 in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01241448Eli Lilly and Company263
已完成
1 期
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes PatientsType 2 Diabetes PatientsNCT01298518Pfizer48
终止
1 期
Multiple Dose Escalation Trial Of PF-04603629 Given To Subjects With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT00637338Pfizer42
已完成
1 期
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01285518Pfizer84
已完成
1 期
Safety and Tolerability of Ascending Intravenous Doses of PF-05231023 In Adult Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01396187Pfizer50