A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination With a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients With Type 2 Diabetes Mellitus (AWARD-JPN: Assessment of Weekly Administration of LY2189265 in Diabetes - JAPAN)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 591
- 试验地点
- 44
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.
- •Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.
- •Have the following HbA1c result at screening.
- •Participants taking DPP-4i: ≥7.5% and ≤9.5%,
- •Participants taking another OAM: ≥8.0% and ≤10.0%
- •Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks
- •Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and <35 kg/m² at Day 1.
排除标准
- •Have type 1 diabetes (T1D)
- •Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
- •Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)
- •Have a known clinically significant gastric empty abnormality
- •Have acute or chronic hepatitis
- •Have had chronic or acute pancreatitis
- •Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia
- •Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)
- •Have evidence of significant, active autoimmune abnormality
- •Have evidence of significant, uncontrolled endocrine abnormality
- •Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
- •Have any hematologic condition that may interfere with HbA1c measurement
研究组 & 干预措施
Dulaglutide 1.5 milligram (mg)
Participants received 1.5 mg of dulaglutide given weekly subcutaneously (SC) during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 oral antihyperglycemic medication (OAM). Participants on dipeptidyl peptidase-4 inhibitors (DPP-4i) discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
干预措施: Dulaglutide (Drug)
Dulaglutide 1.5 milligram (mg)
Participants received 1.5 mg of dulaglutide given weekly subcutaneously (SC) during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 oral antihyperglycemic medication (OAM). Participants on dipeptidyl peptidase-4 inhibitors (DPP-4i) discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
干预措施: Oral antihyperglycemics (Drug)
Dulaglutide 0.75 mg
Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
干预措施: Dulaglutide (Drug)
Dulaglutide 0.75 mg
Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
干预措施: Oral antihyperglycemics (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
时间窗: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pre-study oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment × Time as variables.
次要结局
- Change From Baseline in Fasting Serum Glucose (FSG)(Baseline, Week 52)
- Change From Baseline in HbA1c at Week 52(Baseline, Week 52)
- Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%(Week 52)
- Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)(Baseline, Week 26)
- Change From Baseline in Body Weight(Baseline, Week 52)