EUCTR2017-003490-33-AT进行中（未招募）1 期
A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide DosesWhen Added to Metformin in Patients with Type 2 Diabetes Mellitus - AWARD 11
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
- 1,800
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
- •Have had T2D for =6 months according to the World Health Organization (WHO) classification treated with stable doses of metformin for at least 3 months.
- •Men or nonpregnant women aged =18 years;
- •Have HbA1c =7.5% and =11.0% inclusive;
- •Treated with stable doses of metformin for at least 3 months prior to screening, and between screening and randomisation;
- •Have stable body weight for at least 3 months prior to screening;
- •Have a body mass index (BMI) =25 kg/m2;
- •In the investigator’s opinion, are well-motivated, capable, and willing to:
- •[a] self-inject treatment as required (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject)the study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study drug);
- •[b] perform finger stick PG monitoring at least once daily every day and up to 6 times one day per week at designated times throughout the trial;
- •[c] maintain a study diary
- •women of childbearing potential participating must agree to remain abstinent, or use 1 highly effective method of contraception, or a combination of 2 effective methods of contraception starting at screening and continuing until 4 weeks after the last dose of the randomized therapy;
- •Women of childbearing potential participating must test negative for pregnancy at screening followed by a negative urine pregnancy test within 24 hours prior to exposure;
- •Women must not be breastfeeding;
- •Women not of childbearing potential may participate;
- •Have given written consent to participate in this study.
- •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 1380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 420
排除标准
- •Have type 1 diabetes;
- •Have had any of the following CV conditions within 2 months prior to screening: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke);
- •Have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®) or chronically take drugs that directly reduce gastrointestinal motility;
- •Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or alanine aminotransferase level >2.5 times the upper limit of the reference range;
- •Have had chronic or acute pancreatitis any time prior to study entry;
- •Have an eGFR <30 mL/min/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label);
- •Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2;
- •Have serum calcitonin =20 ng/L,
- •Have evidence of significant, active autoimmune abnormality (eg, lupus, rheumatoid arthritis);
- •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;
- •Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator;
- •Have used any GLP-1 RAs (including investigational agents with GLP-1 RA activity) or insulin at any time in the past, except for short-term (=14 consecutive days) use of insulin for acute conditions;
- •Have used any other glucose-lowering medications other than metformin (including insulin) 3 months prior to study entry or during the Screening/Lead-In Periods;
研究者
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