A Phase 2, Double-Blind, Placebo-Controlled, 3-Month Trial of LY3298176 Versus Placebo in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 13
- 主要终点
- Change From Baseline in Haemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (American Diabetes Association 2017).
- •Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.
- •If on metformin, have been treated with stable doses of metformin for at least 3 months.
- •Have a body mass index (BMI) between 23 and 45 (Inclusive) kilograms per square meter.
排除标准
- •Have type 1 diabetes (T1D).
- •Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past 12 months.
- •Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).
- •Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
- •Have had chronic or acute pancreatitis any time prior to study entry.
- •Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.
- •Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.
- •Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.
研究组 & 干预措施
4,8,12mg Tirzepatide
Participants received Tirzepatide by subcutaneous (SC) injection in three dose escalations starting with 4 milligrams (mg) for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
干预措施: Tirzepatide (Drug)
2.5,5,10,15mg Tirzepatide
Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
干预措施: Tirzepatide (Drug)
2.5,7.5,15mg Tirzepatide
Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
干预措施: Tirzepatide (Drug)
Placebo
Placebo administered by SC injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Haemoglobin A1c (HbA1c)
时间窗: Baseline, 3 Months
Least squares (LS) mean was calculated using mixed model repeated measures model (MMRM) with baseline + baseline BMI group + baseline metformin flag + treatment + time + treatment\*time as fixed factors.
次要结局
- Change From Baseline in Waist Circumference(Baseline, 3 Months)
- Change From Baseline in Body Weight(Baseline, 3 Months)
- Number of Participants With Anti Drug Antibodies(Baseline through 3 Months)
- Percentage of Participants Achieving HbA1c Target of <7.0%(3 Months)
- Change From Baseline in Fasting Blood Glucose (FBG)(Baseline, 3 Months)
- Number of Episodes of Total Hypoglycemia Episodes(Baseline through 3 Months)
- Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide(Week 4, 8 12: Pre-dose)