A Randomised, Placebo-controlled, Double-blind, Semi-sequential Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Escalating Subcutaneous Doses of Glutazumab in Subjects with Type 2 Diabetes

Gmax Biopharm Australia Pty Ltd0 个研究点目标入组 44 人开始时间: 2017年6月2日最近更新: 2019年10月22日

适应症

试验速览

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•Type 2 Diabetes diagnosed >6 months ago and controlled with diet or exercise alone or on stable doses of 1 or 2 of the following classes of OAMs:
•Metformin; Sulfonylureas;Glinides; Thiazolidinediones; Acarbose.
•-If more than 2 of the permitted OAMs listed above are taken at Screening a wash-out period of 3 weeks will be needed.
•- Body Mass Index (BMI) greater than or equal to 27 kg/m squared2 and less than or equal to 40 kg/m squared2
•- Glycated haemoglobin (HbA1c) greater than or equal to 6.5% and less than or equal to 10.5%
•- Fasting C-peptide greater than or equal to 0.8 ng/mL (greater than or equal to 0.26 nmol/L)
•-Lipids, untreated or controlled with lipid-lowering drugs:
•a.Total cholesterol less than 200 mg/dL
•b.Low-density lipoprotein less than 100 mg/dL
•c.Fasting triglyceride level less than 400 mg/dL
•- Females must be non-lactating
•-Females or female partners of male study subjects must be surgically sterile or at least 2-years postmenopausal, or if of childbearing potential, have a negative urine pregnancy test at Screening and be willing to practice sexual abstinence or use an accepted form of contraception with her partner during treatment and for at least 30 days following the last dose of study drug.

•- Type 1 diabetes
•- Any insulin use within 30 days prior to Screening or less than 7 days of consecutive insulin use in the 3 months prior to Screening
•-Clinically significant cardiovascular and/or cerebrovascular diseases including, but not limited to stroke or transient ischemic attack, Active, unstable coronary heart disease, Unstable angina etc.
•-Clinically significant laboratory abnormalities, including but not limited to Bilirubin, Aspartate aminotransferase (AST), glomerular filtration rate, etc.
•- Lipase and amylase at Screening > upper limit of normal (ULN)
•- History of acute or chronic liver disease
•- Positive hepatitis B surface antigen or positive hepatitis C virus testing or positive for HIV
•- Currently ongoing symptomatic biliary disease or history of acute/chronic pancreatitis.
•- Poorly controlled hyperthyroidism (thyroid-stimulating hormone greater than 2 times ULN).
•- Use of any GLP-1 analogue and/or DPP4 inhibitor within the last 30 days.
•- Significant allergies to humanised monoclonal antibodies or allergies to other components of the study medication
•- Females who are pregnant or breast-feeding and subjects of both sexes of childbearing potential who are not willing to use adequate contraceptive methods.

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