NCT01869959已完成1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2405319 With 28 Days of Subcutaneous Injections in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It was given as a daily injection under the skin to participants with type 2 diabetes mellitus (T2DM) for 28 days. This study determined how long the drug stays in the body and how it affects blood sugar levels. After screening, the study lasted about 2 months for each participant. Participants continued their prestudy regimen of diet and exercise alone or in combination with metformin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Have a diagnosis of T2DM.
- •Are on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days) regimen.
- •Have a glycosylated hemoglobin A1c (HbA1c) value of 7.0% to 10.0%, inclusive, or are on metformin and an additional oral antidiabetic medication (OAM) with an HbA1c value of 6.5% to 9.5%, inclusive.
- •Participants on another OAM in addition to metformin therapy may be randomized if removed from treatment of the other OAM ≥14 days prior to study drug administration and fasting blood glucose is ≥145 mg per deciliter (mg/dL) and ≤270 mg/dL.
- •Are females not of child-bearing potential due to surgical sterilization or are postmenopausal.
- •Have a body mass index (BMI) ≥25 and ≤
- •Have clinical laboratory test results within normal reference range for the population.
排除标准
- •Use insulin, thiazolidinediones (TZDs), dipeptidyl peptidase (DPP) IV inhibitors, or exenatide during the 3 months prior to screening.
- •Have had more than 1 episode of severe hypoglycemia requiring assistance of another person to administer a resuscitative action within 6 months prior to entry into the study or are currently diagnosed with having hypoglycemia unawareness.
- •Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
- •Have any abnormality of the electrocardiogram (ECG) that will, in the opinion of the investigator, impair the ability to measure the QT (a corrected QC [QTc] [Bazett's correction] interval >450 milliseconds [msec] for men and >470 msec for women or a PR interval >220 msec are specifically excluded) or have conduction abnormalities that may confound the QTc analysis.
- •Have a personal or family history of long QT syndrome, family history of sudden death, personal history of unexplained syncope within the last year; or use prescription or over-the-counter medications known to prolong the QT or QTc interval.
- •Have diastolic blood pressure (DBP) ≥95 millimeters of mercury (mm Hg) and/or systolic blood pressure (SBP) ≥160 mm Hg.
- •Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for <5 years.
- •Have a history of a transplanted organ.
- •Evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator, at screening.
- •Have a history of human immunodeficiency virus (HIV).
- •Have a known allergy to yeast or yeast proteins, history of anaphylaxis with bronchospasm, or atopic dermatitis with chronic urticaria.
- •Have any other condition (including known drug or alcohol abuse or psychiatric disorder within the last 6 months) that may preclude the participant from following and completing the protocol.
- •Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (including pancreatitis), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
- •Are women who are breastfeeding.
- •Have had a significant change in weight, defined as a gain or loss of at least 4 kilograms (kg) (9 pounds) in the 90 days prior to randomization.
- •Have taken in the 30 days prior to randomization, a medication, herbal product, or nutritional supplement that affects adipose mass or distribution or energy balance.
- •Are receiving chronic (>2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to second screening appointment.
- •Have current or recent (within the past 3 months) use of gemfibrozil or fenofibrate, niacin, ezetimibe, or bile acid binding resins (for example, cholestyramines). Stable statin therapy of ≥3 months will be allowed.
- •Are currently taking central nervous system (CNS) stimulant.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.
干预措施: Placebo (Drug)
3 mg LY2405319
Experimental
Participants received 3 milligrams (mg) LY2405319 injected SC once daily for 28 days.
干预措施: LY2405319 (Drug)
10 mg LY2405319
Experimental
Participants received 10 mg LY2405319 injected SC once daily for 28 days.
干预措施: LY2405319 (Drug)
20 mg LY2405319
Experimental
Participants received 20 mg LY2405319 injected SC once daily for 28 days.
干预措施: LY2405319 (Drug)
结局指标
主要结局
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 56
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
次要结局
- Change From Baseline to Day 28 in Fasting Glucose(Baseline, Day 28)
- 7 Point Self-monitored Blood Glucose (SMBG)(Baseline (Day -5, -4, or -3) and Week 4 (Days 24, 25, or 26))
- Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC)(Predose and 2 hours postdose (Baseline, Week 4))
- Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC)(Predose and 2 hours postdose (Baseline, Week 4))
- Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC)(Predose and 2 hours postdose (Baseline, Week 4))
- Change From Baseline to Day 28 in Fasting Lipid Profile(Baseline, Day 28)
- Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319(Predose through Day 28 (48 hours postdose))
- Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319(Predose through Day 28 (48 hours postdose))
- The Number of Participants With Anti-LY2405319 Antibodies(Day 1 through Day 56)
- Change From Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger(Baseline, Day 28)
- Change From Baseline to Day 28 in Body Weight(Baseline, Day 28)
- Change From Baseline to Day 28 in Adiponectin(Baseline, Day 28)
- Change From Baseline to Day 28 in C-Reactive Protein(Baseline, Day 28)
- Change From Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score(Baseline, Day 28)
- Change From Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score(Baseline, Day 28)
研究者
研究点 (1)
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