Patients with Type 2 Diabetes aged 18-65 are needed for a paid clinical trial testing a new drug which may be useful in the treatment of Type 2 Diabetes Mellitus.
To see if you qualify for the trial, complete the form on the right.
The drug being tested is AZP-531. It is hoped that the drug will lower blood sugar in people with Type 2 Diabetes without causing hypoglycaemia which is a side affect of many treatments in use at present.
The purpose of the study is to examine the safety, tolerability and the way the body handles increasing doses of the drug.
The study involves a 17 night inpatient stay at the unit. Participants will be compensated £3,875 for their time and inconvenience.
Travel expenses will also be paid.
To be eligible to part, you must:
Patients cannot be vegetarian or vegan and must be able to consume meals provided while resident in the clinic.
Screening is to determine whether you are eligible for the study. It will involve a doctor discussing your medical history with you, recording any medications you are currently taking, and performing a physical examination.
Tests you will have during screening will include vital signs (heart rate and blood pressure), a height and weight check, an electrocardiogram (ECG - a non-painful recording of the electrical impulses generated by the heart), blood tests which include a test for the virus that causes hepatitis B and C (inflammation of the liver) and HIV (the virus that causes AIDS) and urine tests including a urine drug and alcohol screen.
A waist circumference check will be performed and for female volunteers a urine pregnancy test and hormonal blood sample will be taken at the same time as your other blood samples.
Admission will involve a single admission of 18 days and 17 nights. Throughout the study you will continue to take your usual dose of metformin at approximately the usual time. You will be admitted to Quintiles two days before dosing (Day –2). On the day of admission you will have a medical examination, vital signs, an electrocardiogram, a height and weight check, a waist circumference measurement and blood and urine samples will be taken for a safety assessment and in order to re-assess your suitability to participate in the trial. Trained staff will insert an interstitial tissue glucose sensor, a fine specialised sterile needle-like device approximately 2 cm long which is injected under the skin of your abdomen and remains in place until Day 2, following which it is removed, with an overlying plastic disc from which glucose data are uploaded via a USB connector. The device is convenient to wear and watertight. Inserting the sensor is straightforward and takes only a few minutes.
On the next morning following admission (Day -1) an intravenous cannula (a fine plastic tube) will be inserted into one of the veins in your forearm, through which we will take blood samples to measure glucose, insulin, fructosamine (another measure of diabetes control) other safety tests and concentrations of AZP-531 (the study drug) in your blood.
On Days 1 to 14 the study drug or placebo (dummy drug) will be administered. The drug will be injected under the skin of your abdomen. By the end of the study you will have received up to 28 doses of AZP-531 or placebo.
Blood samples for safety, drug concentrations and drug effects will be taken at intervals during the 14 day dosing period, and before day 14 another interstitial fluid glucose monitor will be inserted under the skin of your abdomen for glucose monitoring at the end of the dosing period. This will be removed before you are discharged from the Unit. You will receive a standard diet throughout the residential period, and in particular will receive an identical menu for each meal (breakfast, lunch, afternoon snack and dinner) on days -1, 1 and 14. You must not consume any other food or beverage except for water. You will be discharged from the unit on day 16 approximately 48 hours after receiving your final dose (Day 14) providing your safety tests are satisfactory.
You will be asked to return for a follow up appointment, 12-15 days after receiving your final dose. This will involve the collection of blood and urine samples, a physical examination, medical history update since discharge, ECG, vital signs and measurement of your body weight.