A Phase 1, single dose, dose-ascending study of VRS-859, to observe the safety, tolerability and effect in Patients with Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12610000839000
• Lead Sponsor: Versartis Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: To determine the safety and tolerability of a single dose of VRS-859 in Type 2 Diabetes Mellitus patients.[Timepoint 1: VRS-859 is administered as a single dose on Day 1. Safety and tolerability will be regularly assessed with the patient confined to the site for 48 hrs after administration. Out-patient follow-up visits will then be performed on Days 4, 8, 11, 15, 18, 22, 25 and 30. A follow-up visit will then take place at Day 60 after study drug is administered. <br>Safety and Tolerability will be measured by vital signs, an electrocardiogram (ECG), a physical exam, blood and urine tests performed through-out all visits.]