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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prosidion Ltd.

Criteria

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.