A 52-Week, Open-Label, Long-Term Safety Study of LY2189265 in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
- •Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening
- •Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (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 within the 3 months before screening
- •Participants who are currently taking insulin or have had previous insulin treatment within the 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 + Sulfonylureas (SU)
LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
干预措施: LY2189265 (Drug)
LY2189265 + Sulfonylureas (SU)
LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
干预措施: Sulfonylureas (SU) (Drug)
LY2189265 + Biguanides (BG)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
干预措施: LY2189265 (Drug)
LY2189265 + Biguanides (BG)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
干预措施: Biguanides (BG) (Drug)
LY2189265 + alpha-glucosidase inhibitor (a-GI)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
干预措施: LY2189265 (Drug)
LY2189265 + alpha-glucosidase inhibitor (a-GI)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
干预措施: alpha-glucosidase inhibitor (a-GI) (Drug)
LY2189265 + Thiazolidinedione (TZD)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
干预措施: LY2189265 (Drug)
LY2189265 + Thiazolidinedione (TZD)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
干预措施: Thiazolidinedione (TZD) (Drug)
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
干预措施: LY2189265 (Drug)
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
干预措施: Glinides (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Baseline through 52 Weeks
A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Percentage of Participants With Hypoglycemic Episodes
时间窗: Baseline through 52 Weeks
The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. 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 in Glycosylated Hemoglobin (HbA1c)(Baseline, up to 26 Weeks and up to 52 Weeks)
- Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)(Baseline, up to 26 weeks and up to 52 weeks)
- Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%(26 weeks and 52 weeks)
- Change From Baseline in Body Weight(Baseline, up to 26 weeks and up to 52 weeks)
- Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)(Baseline, up to 26 weeks and up to 52 weeks)
- Change From Baseline in Fasting Blood Glucose (FBG)(Baseline, up to 26 weeks and up to 52 weeks)