A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 917
- 试验地点
- 67
- 主要终点
- Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
研究概览
简要总结
The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months
- •Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use [≤14 consecutive days] for acute conditions)
- •HbA1c ≥7.5% to ≤11.0% at screening
- •Stable weight (±5%) ≥3 months, and agree to not initiate a 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
- •Body mass Index (BMI) ≥23 kilograms per meter squared
排除标准
- •Type 1 diabetes mellitus
- •Have history of chronic or acute pancreatitis
- •Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
- •Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
- •Have a history of ketoacidosis or hyperosmolar state/coma
- •Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility
- •Have acute myocardial infarction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months
- •Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 3 months
研究组 & 干预措施
5 mg Tirzepatide
Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).
干预措施: Tirzepatide (Drug)
10 mg Tirzepatide
Participants received 10 mg tirzepatide administered SC QW.
干预措施: Tirzepatide (Drug)
15 mg Tirzepatide
Participants received 15 mg tirzepatide administered SC QW.
干预措施: Tirzepatide (Drug)
Insulin Glargine
Participants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
时间窗: Baseline, Week 40
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 with covariates Baseline + Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus Sulfonylurea (SU)) + Treatment + Time + Treatment\*Time (Type III sum of squares).
次要结局
- Percentage of Participants Achieving an HbA1c Target Value of <7.0%(Week 40)
- Mean Change From Baseline in Body Weight(Baseline, Week 40)
- Mean Change From Baseline in HbA1c (5 mg)(Baseline, Week 40)
- Percentage of Participants Achieving an HbA1c Target Value of <5.7%(Week 40)
- Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 40)
- Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score(Baseline, Week 40)
- Mean Change From Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss ≥5%(Week 40)
- Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia(Baseline through end of safety follow-up (Up To Week 44))