A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 636
- 试验地点
- 46
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The reason for this study is to see if the study drug tirzepatide (LY3298176) is effective and safe compared to dulaglutide in participants with type 2 diabetes in Japan.
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
- •Participant must:
- •Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.
- •Have HbA1c meeting the following criteria, as determined by the central laboratory at screening and baseline:
- •for participants who are oral antihyperglycemic medication (OAM)-naïve at screening, ≥7.0% to ≤10.0% at both screening and baseline.
- •for participants who have been taking OAM monotherapy at screening, ≥6.5% to ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline.
- •Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.
- •Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment.
排除标准
- •Participant must not:
- •Have type 1 diabetes mellitus.
- •Have had chronic or acute pancreatitis any time prior to study entry.
- •Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment.
- •Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
- •Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range.
- •Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
- •Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type
- •Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
研究组 & 干预措施
5 mg Tirzepatide
Participants received 5 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 52 weeks.
干预措施: Tirzepatide (Drug)
10 mg Tirzepatide
Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks.
干预措施: Tirzepatide (Drug)
15 mg Tirzepatide
Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.
干预措施: Tirzepatide (Drug)
0.75 mg Dulaglutide
Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks.
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 52
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Baseline BMI Group (\<25 or \>=25 kg/m\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\*Time (Type III sum of squares).
次要结局
- Percentage of Participants With HbA1c of <7.0%(Week 52)
- Change From Baseline in Fasting Serum Glucose(Baseline, Week 52)
- Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 52)
- Change From Baseline in Body Weight(Baseline, Week 52)
- Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline(Week 52)
- Change From Baseline in Fasting Insulin(Baseline, Week 52)
- Change From Baseline in Fasting C-Peptide(Baseline, Week 52)
- Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin)(Baseline, Week 52)
- Change From Baseline in HOMA-2S (Insluin)(Baseline, Week 52)
- Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe Hypoglycemia(Baseline through Week 52)
- Number of Participants With Anti-Tirzepatide Antibodies(Baseline through Week 52)