EUCTR2018-003422-84-HU进行中（未招募）1 期
A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 versus Titrated Insulin Degludec on Glycemic Control in Patients with Type 2 Diabetes - SURPASS-3
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[1] Have been diagnosed with T2DM based on the World Health Organization classification or other locally applicable diagnostic standards
- •[2] Have HbA1c =7.0% (53 mmol/mol) to =10.5% (91 mmol/mol), as determined by the central laboratory at Visit 1
- •[3] Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use [=14 days] for acute conditions)
- •[4] Are on stable diabetes treatment with metformin or metformin plus an SGLT-2i (metformin =1500 mg/day and no more than the maximum approved dose per country-specific label) for at least 3 months prior to Visit 1 and between Visit 1 and Visit 3
- •[5] Are of stable weight (±5%) =3 months prior to Visit 1 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
- •[6] Have body mass index =25 kg/m2 at Visit 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •[10]Have type 1 diabetes mellitus (T1DM)
- •[11]Had chronic or acute pancreatitis any time prior to study entry (Visit 1)
- •[12]Have history of: proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy that requires acute treatment (a dilated fundoscopic examination performed by an ophthalmologist oroptometrist between Visit 2 and Visit 3 is required to confirm eligibility)
- •[13]Have a history of severe hypoglycemia and/or hypoglycemia unawareness within
- •the 6 months prior to Visit 1
- •[14]Have a history of ketoacidosis or hyperosmolar state/coma
- •[15]Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction), have undergone or plan to have during the course of the study:a gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, Lap-Band®), or chronically take drugs that directly affect GI motility
- •[16]Have any of the following CV conditions within 2 months prior to Visit 1: acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF)
- •[17]Have New York Heart Association Functional Classification III and IV CHF
- •[18]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 >3.0 times the upper limit of the reference range, as determined by the central laboratory at study entry; patients with NAFLD are eligible for participation in this trial only if their ALT level is =3.0 times the upper limit of normal (ULN) for the reference range
- •[19]Have an estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label), calculated by Chronic Kidney Disease-Epidemiology, as determined by central laboratory at Visit 1
- •[20]Have evidence of a significant, uncontrolled endocrine abnormality (for example, thyrotoxicosis or adrenal crises), in the opinion of the investigator
- •[21]Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2
- •[22]Have a serum calcitonin level of =35 ng/L, as determined by central laboratory at Visit 1
- •[23]Treatment with any glucose-lowering agent(s) other than stated in the inclusion criteria [4] in a period of 3 months prior to Visit 1 and between Visit 1 and Visit 3
- •[24]Have been treated with prescription drugs that promote weight loss (for example, Saxenda [liraglutide 3.0 mg], Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], Sanorex® [mazindol], Apidex® [phentermine], BELVIQ® [lorcaserin], Qsymia™ phentermine/topiramate combination], Contrave® [naltrexone/bupropion], or similar other body weight loss medications including over-the-counter medications [for example, alli®]) within 3 months
- •prior to Visit 1 and/or between study entry (Visit 1) and randomization (Visit 3)
- •[25] Are receiving chronic (>2 weeks or 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, or inhaled preparations) or have received such therapy within 1 month of Visit 1 or between Visits 1 and 3
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