A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM)

A Phase IIa Study to Build an Understanding of the Pharmacokinetic-Pharmacodynamic Relationship of PSN821 in Type 2 Diabetes Patients (T2DM).

The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of PSN821 in patients with type 2 diabetes.

Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the start of treatment and at the end of a 12 week treatment period as the primary endpoint. HbA1c, fasting plasma glucose and body weight are secondary endpoints.

Inclusion Criteria:

• Patients with Type 2 diabetes according to the American Diabetes Association criteria, diagnosed at least 12 months prior to screening.
• Male or female, between 18 and 75 years of age, inclusive.
• Body Mass Index of 25 - 45 kg/m2, inclusive.
• Diabetes managed on a stable regimen of diet, exercise and metformin monotherapy (without dosage adjustments within 4 weeks prior to screening).
• Haemoglobin A1c (HbA1c) of 7.5 10% at screening.
• Fasting plasma glucose (FPG) of between 7 - 13.3 mmol/L at screening and Day -1.
• Males who are, and whose partners are able to comply with contraceptive advice.
• Females of non child-bearing potential.
• Willing to sign the written Informed Consent Form (ICF) to participate in the study and to abide by the study restrictions.

Exclusion Criteria:

• Patients with Type 1 diabetes or maturity onset diabetes of the young or secondary forms of diabetes, such as due to pancreatitis.
• Marked diabetic complications.
• Illness or medication that impacts on the scientific integrity of the study.