A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes - EXCEED

Hanmi Pharmaceutical Co., Ltd.0 个研究点目标入组 255 人开始时间: 2013年11月11日最近更新: 2015年8月4日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Hanmi Pharmaceutical Co., Ltd.
入组人数: 255

研究概览入排标准研究者记录与标识符相似试验

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)Aged =18 and <75 years at screening
•2)Diagnosed with T2DM for at least 3 months prior to screening
•3)Received diet and exercise therapy with or without metformin monotherapy for at least 3 months prior to screening; for subjects who have taken metformin monotherapy, the following minimum stable (i.e., at least 3 months on this dose) dose requirements apply:
•a)=1500 mg/day of metformin or
•b)maximum tolerated dose (the investigator must have documented the reason why up titration to e.g. = 1500 mg/day was not possible) or
•c)maximum dose according to the country-specific label
•4)HbA1c levels of between = 7.0% and = 10.0%, at screening
•5)BMI of < 40 kg/ m2 at screening
•6)Females of childbearing potential must test negative for serum pregnancy at screening and agree to use a highly effective method of birth control throughout the study and for at least 30 days after Visit 8/ET visit. Child-bearing potential is defined as women who have not been surgically sterilized 6 weeks prior to screening or are post-menopausal = 1 year.
•A highly effective method of birth control is considered to be one of the following:
•-An oral or implanted hormonal method of contraception (if it has been used for = 3 months prior to study drug administration) while also using a barrier method (i.e., a condom or diaphragm)
•-A hormone or copper intrauterine device if it has been in place for = 3 months prior to study drug administration (subjects using a nonhormonal or copper intrauterine device should also use a barrier method [i.e., a condom or a diaphragm])
•-A vasectomised partner
•-Total abstinence is acceptable; however, the subject must use a highly effective method of contraception if the subject subsequently decides not to abstain.
•7)Male subjects must agree to practice highly effective birth control methods during the conduct of the study and for at least 30 days after Visit 8/ET visit
•8)Written informed consent must be obtained before any assessment is performed
•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 245
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

排除标准

•1) Pregnant or nursing (lactating) women
•2)Diagnosis of type 1 diabetes mellitus
•3)Uncontrolled diabetes defined as a FPG level of > 240 mg/dL (13.3 mmol/L) at screening
•4)A significant change in body weight (at least ± 10%) in the 3 months before screening
•5)Medication exclusions apply
•6)Known history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
•7)Any history of GI intolerance (prolonged nausea and vomiting, chronic diarrhoea during the previous 6 months), gastric emptying abnormality, inflammatory bowel disease, partial bypass (ileal bypass) or gastric banding
•8)Any previous GI bleeding or ulceration related to the use of NSAIDswithin 3 months before screening
•9)Subjects with severe heart or circulatory disease within 6 months prior to screening, defined as any one of the following:
•a)Current symptomatic heart failure (New York Heart Association [NYHA] class III or IV) (NYHA 1994; Section 14, Appendix 2);
•b)A myocardial infarction, coronary artery bypass graft surgery, or angioplasty within 6 months of screening;
•c)Diagnosis of unstable angina requiring medication within 6 months of screening; or
•d)Any transient ischemic attack, cerebral infarct, or cerebral haemorrhage within 6 months of screening
•10)Poorly controlled hypertension (a resting systolic blood pressure [BP]>160 mmHg and/or diastolic BP >100 mmHg at screening)
•11)Long QT syndrome or prolongation of QTcF interval (QTcF interval >450 ms for males and >470 ms for females) at screening and baseline
•12)A history of additional risk factors for torsade de pointes (TdP; e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
•13)Liver disease, hepatitis, alanine transaminase (ALT) levels or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal, or total bilirubin > 1.5 times upper limit of normal unless the subject has a known history of Gilbert syndrome
•14)Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Cockcroft Gault formula, at screening
•15)Calcitonin levels > 20 pg/mL (> 20 ng/L) at screening
•16)Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC (i.e., multiple endocrine neoplasia type 2)
•17)Plan to or have had radioactive iodine test with intravenous administration of contrast material (such as intravenous pyelography, intravenous cholangiography, angiography, or computed tomography with contrast medium, etc) within 3 months of screening
•18)Any planned elective hospitalisations
•19)Known history of acute or chronic pancreatitis with presence of raised serum amylase and lipase (= 3 times the upper limit of normal at screening
•20)Fasting serum TG > 400 mg/dL (> 4.52 mmol/L) for at screening(Visit 1B)
•21)Proliferative retinopathy or maculopathy treated within the 6 months before screening or requiring acute treatment
•22)History of or positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibody
•23)History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years before screening. (Any history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)
•24)Use of or a positive screen for drugs of abuse (opiates, cocaine, amphetamines, cannabinoids), barbitura

研究者

发起方

Hanmi Pharmaceutical Co., Ltd.

相似试验

进行中（未招募）

不适用

An study conducted in multiple countres to assess the control of glucose in patients with Diabetes Type 2. This study will compare 5 different dose levels of HM11260C (the study medication) with placebo (no active drug) and a liraglutide (a treatment for diabetes type 2 available by prescription). This will be a twelve week study where the study physician nor the patient will know whether the treatment is placebo or study medication. There is an equal chance of being assigned to any group.Type 2 Diabetes Mellitus

EUCTR2013-003625-29-HUHanmi Pharmaceutical Co., Ltd.255

进行中（未招募）

1 期

EUCTR2013-003625-29-CZHanmi Pharmaceutical Co., Ltd.255

进行中（未招募）

不适用

EUCTR2013-003625-29-NLHanmi Pharmaceutical Co., Ltd.255

进行中（未招募）

不适用

EUCTR2013-003625-29-ESHanmi Pharmaceutical Co., Ltd.255

进行中（未招募）

1 期

EUCTR2013-003625-29-DEHanmi Pharmaceutical Co., Ltd.255