None listed
Conditions
Brief summary
This will be the first time VRS-859 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data from type 2 diabetic patients administered a subcutaneous dose of VRS-859. The study will also provide data on the single dose pharmacokinetics. Assessment of the activity of VRS-859 will be measured by testing fasting plasma glucose (FPG) and response to oral GTTs at selected times post-dose. This combined data will help establish the best dose and optimum dosage regimen for administration to patients. The study design provides an opportunity to evaluate the potential of VRS-859 to be administered monthly to patients that are already on a diet and exercise program with a well established standard of care, metformin. Interim safety assessments of each treatment group (cohort dose) will be made prior to escalating to the next higher dose thus providing additional opportunity to evaluate the overall safety of each dose and to define the safest monthly dose.
Interventions
The drug being studied is called VRS-859, and it is administered subcutaneously (into tissue under the skin).
It is being studied for its effectiveness in the treatment of Type 2 Diabetes Mellitus.
a) There are 5 potential dose groups (12.5mg, 25mg, 50mg, 100mg and 150mg) of VRS-859. There is also a placebo (a simulated medical intervention) that patients may receive.
b) Patients will be assessed in groups of 11, beginning with the lowest dose of VRS-859 or placebo.
c) Doses will be administered
The drug being studied is called VRS-859, and it is administered subcutaneously (into tissue under the skin). It is being studied for its effectiveness in the treatment of Type 2 Diabetes Mellitus. a) There are 5 potential dose groups (12.5mg, 25mg, 50mg, 100mg and 150mg) of VRS-859. There is also a placebo (a simulated medical intervention) that patients may receive. b) Patients will be assessed in groups of 11, beginning with the lowest dose of VRS-859 or placebo. c) Doses will be administered once only. Patients will receive either one, two or three injections depending on the cohort. d) Each patient will be monitored at regular intervals for a period of 30 days after treatment and then followed-up 60 days after treatment. Only 1 dose group will be dosed at a time, once safety and tolerability are assessed for that group and it is deemed safe to continue, the next dose group will be dosed.
Sponsors
Versartis Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
21 Years to 62 Years
Healthy volunteers
No
Inclusion criteria
1. Age 21 to 62 years 2. Body Mass Index (BMI) between 25 and 40 kg/m2 inclusive and a minimum body weight of 50 kg 3. Negative serum pregnancy test for females of childbearing potential 4. Diagnosis of Type 2 diabetes at least 6 months prior to dosing as documented in the patient’s medical history 5. Fasting plasma glucose level (inclusive) of 130-260 mg/dL (7.22 – 14.44 mM inclusive) AND glycosylated hemoglobin (HbA1c) range (inclusive) of 7 – 10.5% for patients on metformin alone or 6.5-10% for patients on metformin and sulfonylurea [Patients on sulfonylurea will stop taking it for 2 weeks prior to dosing and will receive metformin during study] 6. Diet and exercise program and on a fixed dose of oral diabetic agent (metformin alone or metformin and sulfonylurea) for at least 3 months prior to enrollment 7. Willing and able to give informed consent 8. QT correction (QTc) value of less than 450 msec by ECG
Exclusion criteria
1. Patients who have received treatment for any bacterial, viral or fungal infection within 30 days of prior to study drug dosing 2. Any oral antidiabetic monotherapy (except metformin or sulfonylurea) within 3 months prior to enrollment 3. Currently taking or have been on treatment with thiazolidinedione (TZD) within the past 3 months 4. Pancreatitis within 5 yrs prior to enrollment 5. Documented history of or current significant cardiovascular, cerebrovascular, renal or hepatobillary disease 6. Pancreatic enzymes (amylase, lipase) outside laboratory normal range 7. Fasting serum triglycerides > 500 mg/dL (5.6 mmol/L) 8. Use of gastric motility drugs within one week prior to study enrollment 9. Positive drugs screen and alcohol breath test at screening or at admission 10. Positive serology for Hepatitis B (HBV), Hepatitis C (HCV), or Human Immunodeficiency Virus (HIV). Must also have no prior history of HBV or HCV virus infection 11. Prior history of cancer excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix 12. Women who are pregnant or breastfeeding 13. Unwilling to use two effective birth control methods while on study 14. Unwilling to abstain from recreational drug use 15. Unwilling to refrain from alcohol use at least 48 hours prior to screening and enrollment. 16. Any prior treatment with glucagon-like peptide-1 (GLP-1) analog (e.g. Byetta, Victoza) 17. Treatment on dipeptidyl peptidase IV (DPP IV) inhibitor within 3 months prior to screening 18. Treatment with an investigational drug within past 30 days prior to screening 19. Treatment with insulin within the past 3 months prior to screening
Outcome results
None listed