EUCTR2016-001857-42-DE进行中（未招募）1 期
A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 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
- •-Participants must be at least 18 years of age at the time of signing the informed consent.
- •-Participants with T2DM, and treated with diet and exercise.
- •-Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.
- •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 640
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •-Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal Reflux disease within 6 months prior to Screening or history of surgery
- •affecting gastric emptying.
- •-History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and
- •pancreatectomy.
- •-Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
- •--Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
- •-Body weight change of =5 kg within the last 3 months prior to Screening.
- •-Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Randomization
- •-End-stage renal disease as defined by estimated glomerular Filtration rate (eGFR , by Modification of Diet in Renal Disease [MDRD]) of <15 mL/min/1.73 m2.
- •-Laboratory findings at the Screening Visit:
- •- Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) >3 times the upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case of documented Gilbert's syndrome).
- •- Amylase and/or lipase: >3 times the ULN laboratory range.
- •- Calcitonin =5.9 pmol/L (20 pg/mL).
- •-Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
- •-History of drug or alcohol abuse within 6 months prior to the time of Screening.
- •-Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
- •-Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention.
研究者
相似试验
进行中（未招募）
1 期
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and ExerciseType 2 diabetes mellitusMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2016-001857-42-GBsanofi-aventis recherche & développement800
进行中（未招募）
1 期
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and ExerciseEUCTR2016-001857-42-PLsanofi-aventis recherche & développement800
进行中（未招募）
1 期
Study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in patients with chronic plaque psoriasis.Chronic plaque psoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2016-001892-57-PLCB Biopharma SPR217
进行中（未招募）
1 期
Study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in patients with chronic plaque psoriasis.Chronic plaque psoriasisMedDRA version: 19.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2016-001892-57-HUCB Biopharma SPR240
进行中（未招募）
1 期
Study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in patients with chronic plaque psoriasis.Chronic plaque psoriasisMedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858EUCTR2016-001892-57-CZCB Biopharma SPR217