A Phase 3 Study of LY2189265 Monotherapy Compared to Placebo and Liraglutide in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 492
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
研究概览
简要总结
The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.
详细描述
Rescue therapy (defined as alternative antihyperglycemic medication use or dose modification of oral antihyperglycemic medication [OAM]) may have been initiated during the planned treatment period if the participant discontinued study drug or met prespecified thresholds for severe, persistent hyperglycemia. Efficacy data, as well as data for hypoglycemic episodes from participants who permanently discontinued study treatment but switched to another diabetes medication and remained in the study, were censored from the point of initiating new treatment onwards.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have had a diagnosis of type 2 diabetes mellitus before screening.
- •Participants who have been Oral Antihyperglycemic Medication (OAM)-naïve (diet and exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and are willing to discontinue this medication. Participants taking OAM monotherapy must complete 8-week washout period prior to randomization.
- •Participants who are OAM naïve with a screening glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value of 7.0% to 10.0%.
- •Participants who have a body mass index (BMI) of 18.5 kilograms per meter squared (kg/m^2) to 35.0 kg/m^2.
排除标准
- •Participants who have a diagnosis of type 1 diabetes.
- •Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog.
- •Participants who have been receiving more than half of the maximum dose of sulfonylureas at screening.
- •Participants who have been currently taking insulin or TZD, or have had previous insulin or TZD treatment within 3 months before screening.
- •Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening.
- •Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC).
研究组 & 干预措施
LY2189265
Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
干预措施: LY2189265 (Drug)
Placebo/LY2189265
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
干预措施: LY2189265 (Drug)
Placebo/LY2189265
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
干预措施: Placebo (Drug)
Liraglutide
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
干预措施: Liraglutide (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
时间窗: Baseline, 26 weeks
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, prestudy therapy (oral antihyperglycemic medication \[OAM\] yes/no), baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks(Baseline, 52 weeks)
- Percentage of Participants Who Achieved HbA1c <=6.5% or <7%(Up to 26 and 52 weeks)
- Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks(Baseline through 26 weeks and Baseline through 52 weeks)
- Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Change From Baseline in Body Weight at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Percentage of Participants With Hypoglycemic Episodes(Baseline through 26 weeks and Baseline through 52 weeks)
- Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks(Baseline through 26 weeks and Baseline through 52 weeks)
- Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks(Baseline through 26 weeks and Baseline through 52 weeks)
- Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- 30-Day Rate of Hypoglycemic Episodes(Baseline through 26 weeks and Baseline through 52 weeks)
- Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks(Baseline through 26 weeks and Baseline through 52 weeks)